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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...
Bacteriostatic 0.9% Sodium Chloride Vials 5/25/2019 8:00:00 PM Drug: Bacteriostatic 0.9% Sodium Chloride Vials, Revision Date: Sun, 26 May 2019 (Click for more...) Bupivacaine with Epinephrine Injection 5/25/2019 8:00:00 PM Drug: Bupivacaine with Epinephrine Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Copper Chloride Injection 5/25/2019 8:00:00 PM Drug: Copper Chloride Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Dexamethasone Sodium Phosphate Injection 5/25/2019 8:00:00 PM Drug: Dexamethasone Sodium Phosphate Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Diazepam Injection 5/25/2019 8:00:00 PM Drug: Diazepam Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Diltiazem Hydrochloride Injection 5/25/2019 8:00:00 PM Drug: Diltiazem Hydrochloride Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Diphenhydramine Injection 5/25/2019 8:00:00 PM Drug: Diphenhydramine Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Leucovorin Calcium Injection 5/25/2019 8:00:00 PM Drug: Leucovorin Calcium Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Lidocaine with Epinephrine Injection 5/25/2019 8:00:00 PM Drug: Lidocaine with Epinephrine Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Potassium Acetate Injection 5/25/2019 8:00:00 PM Drug: Potassium Acetate Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Potassium Phosphate Injection 5/25/2019 8:00:00 PM Drug: Potassium Phosphate Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Remifentanil Injection 5/25/2019 8:00:00 PM Drug: Remifentanil Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Ropivacaine Injection 5/25/2019 8:00:00 PM Drug: Ropivacaine Injection, Revision Date: Sun, 26 May 2019 (Click for more...) Oklahoma takes on drugmakers J&J, Teva in landmark opioid trial 5/24/2019 5:05:01 PM Oklahoma takes on drugmakers J&J, Teva in landmark opioid trial Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 A trial begins Tuesday in Norman, OK, pitting the state against two drugmakers it accuses of fueling the opioid epidemic: Johnson & Johnson and Teva Pharmaceutical Industries. Oklahoma Attorney General Mike Hunter’s $17 billion lawsuit will seek to convince Cleveland County District Judge Thad Balkman to find that the companies created a public nuisance by using deceptive marking that downplayed their drugs’ addictive risks while overstating their benefits. Balkman will rule following the trial, which will last 8 weeks. Oklahoma resolved related claims against OxyContin maker Purdue Pharma LP in March for $270 million. J&J and Teva deny wrongdoing, arguing the state lacks evidence linking any marketing they did to doctors writing unwarranted opioid prescriptions. They also argue that even if they falsely marketed their products, the state cannot prove they caused the opioid epidemic given the role doctors, patients, pharmacists, and drug dealers played in it. The state claims J&J and Teva deceptively marketed opioids with Purdue by retaining prominent doctors to give talks advocating use of opioids to treat chronic rather than short-term pain. It also says the companies funded groups that purported to be independent and these groups in turn promoted the misrepresentations. (Click for more...) Senate health package includes surprisingly aggressive drug pricing reforms 5/24/2019 5:05:01 PM Senate health package includes surprisingly aggressive drug pricing reforms Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA) on Thursday unveiled an unexpectedly ambitious plan to lower the price of prescription drugs. The draft legislation includes several proposals that have the potential to upend PBMs, such as banning spread pricing. The proposal would also mandate that PBMs report a swath of information to their clients, including the net and list price for each drug and the amount of the rebates they receive. The proposal would also require PBMs to pass on 100% of the rebates or discounts they negotiate to their clients. "This definitely reads like a straight-up ban. You can't put the language much more clearly," said Antonio Ciaccia, director of government and public affairs at the Ohio Pharmacists Association. The move was also applauded by the National Community Pharmacists Association, which has largely led the charge against spread pricing, which the group alleges often unfairly benefits pharmacies owned by PBMs, like CVS. Alexander and Murray are known for advancing policies that eventually become law, leading many observers to conclude their measure has a good chance of passage. Meanwhile, House Speaker Nancy Pelosi is reportedly coming closer to finalizing a drug-pricing plan aimed both at mollifying progressives and potentially earning support from Republicans. (Click for more...) Pharm D Solutions issues voluntary recall of all sterile compounded drugs 5/24/2019 5:05:01 PM Pharm D Solutions issues voluntary recall of all sterile compounded drugs Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Pharm D Solutions announced a voluntary recall of all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. The concerns were raised following a routine inspection by FDA. To date, Pharm Solutions is not aware of any adverse events related to the recall. According to the company, "This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority." The recall includes all compounded sterile drug products within expiry that were dispensed from October 24, 2018 to May 21, 2019. (Click for more...) Indy 500 officials to offer measles vaccine at race 5/24/2019 5:05:01 PM Indy 500 officials to offer measles vaccine at race Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Amid a growing number of measles cases in the United States this year, the medical director of the Indianapolis 500 said Thursday that some fans will be able get measles vaccines at the event. The race, which is expected to attract more than 275,000 fans, will be held this Sunday, May 26. According to IndyCar medical director Geoffrey Billows, a "very limited supply" of vaccines will be available at the medical facility near the Indianapolis Motor Speedway museum. However, he urged concerned individuals to get vaccinated prior to attending the race. (Click for more...) Long term tapering vs. standard prednisolone treatment for first episode of childhood nephrotic syndrome 5/24/2019 5:05:01 PM Long term tapering vs. standard prednisolone treatment for first episode of childhood nephrotic syndrome Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 A multisite U.K. trial explored whether prolonging initial prednisolone treatment in children with idiopathic steroid sensitive nephrotic syndrome would improve outcomes in this patient population. The Phase III study included 237 patients aged 1–14 years who experienced their first episode of the disease. Through a randomized process, each was allocated to receive either the usual 8-week course of prednisolone or an extended 16-week course. Study participants were followed for at least 24 months. The primary endpoint was time to first relapse, which ultimately did not differ significantly between the two groups. The rate of frequently relapsing nephrotic syndrome also was comparable, at 50% for patients receiving the standard course of steroids and 53% for those undergoing the longer treatment period. Secondary clinical outcomes, including the need for alternative immunosuppressive treatment and the rate of adverse events, were mostly similar between the groups; however, generic quality of life and cost savings were improved with the extended course of prednisolone. (Click for more...) Effects of antiplatelet therapy after stroke due to intracerebral hemorrhage 5/24/2019 5:05:01 PM Effects of antiplatelet therapy after stroke due to intracerebral hemorrhage Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 U.K. researchers speculated that antiplatelet or anticoagulant therapy might safely and effectively lower the risk of major vascular events in adult survivors of intracerebral hemorrhage. They designed a prospective trial, called RESTART, and populated it with patients meeting this profile who previously had been taking antithrombotic medicine for the prevention of occlusive vascular disease. Patients who discontinued the therapy after intracerebral hemorrhage and survived for at least 24 hours were randomly assigned to either remain off the antiplatelet regimen or to reinitiate it. The primary outcome, assessed after a median 2 years, was the rate of recurrent symptomatic intracerebral hemorrhage. Among 268 study participants who restarted antithrombotic therapy, 4% experienced the main endpoint compared with 9% of an equal number of participants who did not resume antiplatelet or anticoagulant treatment. The share in each group who suffered major hemorrhagic events was 7% and 9%, respectively. For major occlusive vascular events, the incidence rates were 15% and 14%, respectively. The results suggest that reinitiating antithrombotic therapy presents only a very small risk of recurrent intracerebral hemorrhage in this patient population—and likely not enough to offset the clear benefits of antiplatelet therapy as secondary prevention against occlusive vascular disease. (Click for more...) Pharmacy among industries Amazon could disrupt 5/24/2019 5:05:01 PM Pharmacy among industries Amazon could disrupt Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 A new CB Insights research brief outlines how Amazon will be a disruptive influence in the pharmacy industry as it works its way into the business of drug distribution. Amazon's 2018 acquisition of PillPack, a $100 million-plus business with pharmacy licenses in all 50 states represents its first significant move not just against the major community pharmacy chains, but against the powerful PBMs that manage the dispensation of drugs for major employers, and others in the health care supply chain. The full report can be found here. (Click for more...) FLAVORx now available at Walmart Neighborhood Markets 5/24/2019 5:05:01 PM FLAVORx now available at Walmart Neighborhood Markets Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Walmart announced this week that it is offering FLAVORx with certain liquid prescriptions for no additional cost at its Neighborhood Market pharmacies. "We know our customers face a lot of challenges during the day and getting your child to swallow necessary medications shouldn't be one of them," said Jay Picklesimer, senior director of Walmart Neighborhood Market Health & Wellness Operations. "While we have previously offered FLAVORx at a nominal fee to parents, we are now offering it at no additional cost to take the guesswork out of convenience and continuing our mission of offering affordable health care." FLAVORx reports that pediatric adherence rates of taking medication generally hold at about 60%; however, when medications are custom-flavored, the rates can jump to 90% or more. (Click for more...) Ex-FDA commissioner goes back to biotech investing 5/24/2019 5:05:01 PM Ex-FDA commissioner goes back to biotech investing Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Former FDA Commission Scott Gottlieb, MD, will return to his former life science venture capital firm, New Enterprise Associates (NEA), the company announced this week. Gottlieb, who left the FDA in early April, will be a "special partner" at NEA. He previously spent about a decade there before becoming FDA commissioner in 2017. "We are proud of his contributions to advancing innovation and increasing the quality of patient care as head of the FDA, and we're thrilled to have him rejoin NEA, this time as a full-time investing partner," said David Mott, general partner and head of health care investing at NEA. (Click for more...) Pharmacists phone home post-discharge 5/24/2019 5:05:01 PM Pharmacists phone home post-discharge Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 An Irish study found that having pharmacists make a series of follow-up phone calls to patients after hospital discharge achieved lower rates of readmission. Drawing from a 426-bed hospital in Northern Ireland, the study matched patients who received three pharmacist-led, post-discharge telephone calls with a control group. Each group consisted of 211 patients, two-thirds of whom were older than age 65 years, and all of whom took at least 10 medications for chronic illness, managed their own medications, and were not discharged to a nursing home, hospice, or different hospital. During each call, the pharmacist discussed patient concerns, assessed their ability to manage their medications, and provided advice for adherence. The intervention group saw 9.9% lower 30-day admission rates and 15.2% lower 90-day admission rates than the control group. The calls were also associated with shorter hospital stays and lower hospital costs if the patient was readmitted as well as improved medication adherence overall. (Click for more...) Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range 5/24/2019 5:05:01 PM Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 U.S. regulators are expected to decide this month whether or not to approve Novartis's onasemnogene abeparvovec (Zolgensma), a 1-time gene therapy for spinal muscular atrophy (SMA). Although the company originally said it expected to price the treatment in the $4 million to $5 million range, Novartis CEO Vas Narasimhan said it will price the therapy for much less. "We won't be announcing the price until we get the approval," he said. "But our overall goal is to be at a fraction of what is the current standard of care, and the current standard of care for treating these patients is $4 million to $5 million over 10 years." The current treatment for SMA is Biogen's nusinersen sodium (Spinraza), which has a list price of $750,000 for the first year and $375,000 annually thereafter. (Click for more...) Improper proton pump inhibitor prescriptions criticized 5/24/2019 5:05:01 PM Improper proton pump inhibitor prescriptions criticized Thu, 05/23/2019 - 20:00 cbaker_admin Fri, 05/24/2019 - 17:05 Patrick Meek, PharmD, from Albany College of Pharmacy and Health Sciences in New York, says prescriptions for proton pump inhibitors (PPIs) have surged over the past 2 decades, along with concerns over inappropriate use and adverse events. Prescriptions for PPIs increased from 1.6% of ambulatory care visits in 1998 to 7.6% in 2015, reported Meek, who presented an analysis of data from the National Center for Health Statistics at Digestive Disease Week 2019. Residents often have a "very poor" understanding of PPIs, which can lead to overprescription, said Chiemeziem Eke, MD, from the Baylor College of Medicine in Houston, who said data indicates that 77% of PPIs were overprescribed in a primary care clinic. Eke and his colleagues developed an intervention that discusses indications for PPIs and the consequences of long-term use. They also provided a taper tool in the electronic medical records and a 4-week PPI taper order, along with a deprescribing algorithm. The taper order called for a decrease to every other day for 2 weeks, then every 4 days for 2 weeks, and then cessation if the PPI was not prescribed for one of the following indications: Barrett's esophagus, severe esophagitis, peptic stricture from reflux esophagitis, Zollinger-Ellison syndrome, a history of a bleeding gastrointestinal ulcer, or chronic NSAID use in patients with bleeding risk factors. During the study period, there was a 16% drop in PPI dispensing—from 66,261 to 55,322—and a decline in PPI prescriptions deemed inappropriate from 77% to 52%. (Click for more...) Novartis slaps $2M-plus price tag on newly approved gene therapy Zolgensma—and cost watchdogs approve 5/24/2019 1:32:16 PM Industry watchers have been speculating for months about just how high Novartis would price gene therapy Zolgensma—and just how payers would cover the "transformative" spinal muscular atrophy treatment. Now, they have their answers. (Click for more...) Purdue funneled money to nonprofits, WHO employees to sway opioid guidance: report 5/24/2019 10:10:38 AM Since its inception in 1948, the World Health Organization’s role has been, in part, to provide international prescribing guidance without an eye on profits. But what happens when a fox is let loose in the henhouse, and that guidance is tainted by private money? (Click for more...) Mass exodus of Amgen sales reps sparks legal battle with multiple myeloma rival Karyopharm 5/24/2019 10:06:55 AM After 19 salespeople resigned from Amgen last year to join Karyopharm, which is preparing to launch a rival multiple myeloma drug, Amgen sued, alleging theft of trade secrets. Now, as it awaits an FDA decision on its multiple myeloma drug selinexor, Karyopharm is fighting to get the suit thrown out. (Click for more...) CDC reminds providers they don’t need to screen adults for measles immunity 5/24/2019 8:56:02 AM CDC reminds providers they don’t need to screen adults for measles immunity Fri, 05/24/2019 - 09:07 ehaberkorn@aph… Fri, 05/24/2019 - 08:56 In summary, CDC said: (Click for more...) Final NICE guidance issued for Akcea’s Tegsedi 5/24/2019 7:12:49 AM The drug should be available for routine use within 90 days for patients in England. (Click for more...) GSK updates its sales rep incentives 5/24/2019 7:12:25 AM The company implemented stricter rules in 2012 as part of a broad transparency initiative. (Click for more...) NHS to undergo ‘ambitious’ tech overhaul 5/24/2019 7:12:01 AM In the past three months alone, the NHS has prevented more than 21 million potential cyber attacks. (Click for more...) AZ’ HER2 drug hits mid-stage trial endpoints 5/24/2019 7:11:37 AM The drug has been granted US FDA Breakthrough Therapy Designation and Fast Track Designation. (Click for more...) LifeArc receives $1.2b in Keytruda royalties 5/24/2019 7:11:14 AM In 2016, LifeArc sold a small proportion of its Keytruda royalty interest for $150 million to a private equity fund. (Click for more...) FiercePharmaAsia—Shingrix's Chinese nod; Chugai's $1B R&D site; Lilly's Verzenio safety woes 5/24/2019 7:02:12 AM GlaxoSmithKline's Shingrix wins nod to tackle China but won't launch until 2020; Roche's Chugai plunks down $1 billion for a new R&D site in Japan; Eli Lilly's oncology rising star Verzenio faces a safety warning in Japan; and more. (Click for more...) School of Pharmacy graduate student wins award at global conference 5/24/2019 12:00:00 AM (Click for more...) Where Should I Publish? Using Library Resources for Manuscript Submission Decisions 5/24/2019 12:00:00 AM Find the right journal to publish your article in using library resources such as the Web of Science Core Collection, InCites Journal Citation Reports, and EndNote Match. Bring your completed or partial journal manuscript title/abstract and keywords to search and analyze the literature. (Click for more...) House committee proposes 6% increase in FDA funding for FY 2020 5/23/2019 4:05:01 PM House committee proposes 6% increase in FDA funding for FY 2020 Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 A draft fiscal year 2020 funding bill for the FDA calls for a $184 million increase in discretionary funding over this year's enacted level, according to the House Appropriations Committee. Total FDA funding would be $5.86 billion, slightly lower than the $6.1 billion that the Trump administration has requested for the agency. "Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation's blood supply and to enable faster responses to foodborne illness outbreaks. In addition, the bill includes a strong focus on continuing FDA's efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.," the committee said. The committee will hold a markup of the bill on Thursday. (Click for more...) Mallinckrodt sues U.S. health agencies, sees 10% hit to corticotropin gel sales 5/23/2019 4:05:01 PM Mallinckrodt sues U.S. health agencies, sees 10% hit to corticotropin gel sales Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 Mallinckrodt has filed a lawsuit against HHS and CMS following changes to Medicaid rebate calculations. Corticotropin (Acthar—Mallinckrodt), which is used to treat infantile spasms and multiple sclerosis, is the company's biggest revenue generator, but its annual sales growth has been slowing since 2016. CMS recently changed how it calculates Medicaid discounts for corticotropin gel. Mallinckrodt said the change could result in a 1-time charge of up to $600 million. "While it remains to be seen whether Mallinckrodt's lawsuit will allow it relief from CMS' ruling, this will be yet another near-term overhang on Acthar," said Ami Fadia, an analyst with SVB Leerink. (Click for more...) Baltimore files antitrust suit against biotech company 5/23/2019 4:05:01 PM Baltimore files antitrust suit against biotech company Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 In an antitrust lawsuit, the city of Baltimore says Jannsen Biotech inflated costs for its prostate cancer drug. The city says it filed suit to recover damages from the company, which is part of Johnson & Johnson. Among other things, Baltimore alleges that Janssen pursued "sham litigation" and attempted to inflate costs for abiraterone acetate (Zytiga—Janssen Biotech), a prostate cancer drug that has earned billions of dollars. Baltimore claims its prescription drug plans were unjustly compelled to pay "inflated" prices since 2016, when the company's original patent expired. Michelle Larkin, a Janssen spokeswoman, says the biotech company "stands by its decision to defend the validity and infringement of the relevant patent." (Click for more...) McConnell, Kaine introduce bill to raise tobacco purchasing age from 18 to 21 5/23/2019 4:05:01 PM McConnell, Kaine introduce bill to raise tobacco purchasing age from 18 to 21 Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 Legislation was introduced this week by Sens. Mitch McConnell (R-KY) and Tim Kaine (D-VA) to raise the minimum tobacco purchasing age from 18 years to 21. "We're proud of our past, and we're proud of who we are, but Kentucky farmers don't want their children to get hooked on tobacco products while they're in middle or high school any more than any parents anywhere want that to happen," McConnell said. FDA has warned it will clamp down on the e-cigarette industry if high youth vaping rates do not decline, such as by pulling products off the markets. Earlier this year, the agency issued a proposal requiring that stores only sell flavored e-cigarettes in areas that are off limits to anyone under age 18 years. (Click for more...) Congressional report: Pharmaceutical industry influenced WHO's opioid guidelines 5/23/2019 4:05:01 PM Congressional report: Pharmaceutical industry influenced WHO's opioid guidelines Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 A new congressional report from the offices of Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY) concludes that guidelines from the World Health Organization (WHO) on treating pain were directly influenced by the pharmaceutical industry, including a set of directions for prescribing opioid analgesics that appear to have been taken from Purdue Pharma. "The web of influence we uncovered, combined with the WHO's recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry," states the report, which was issued Wednesday. Purdue "strongly denies the claims" in the report, asserting that it "seeks to vilify the company through baseless allegations." Clark and Rogers's report also alleges that Purdue's marketing was based on the premise that prescription opioids were safe and effective and that addiction was rare, something the legislators say WHO also pushed in its guidelines. The report claims that both Purdue and the WHO played down the risk of addiction, with the global health organization saying there was an "unreasonable fear" of opioids. Clark says she wants WHO to explain the guidelines and whether they were influenced by corporate strategy. (Click for more...) Massive sequencing study links rare DNA alterations to type 2 diabetes 5/23/2019 4:05:01 PM Massive sequencing study links rare DNA alterations to type 2 diabetes Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 An analysis of protein-coding genes from more than 45,000 people links rare genetic variants with type 2 diabetes. The study, published in Nature, identified four genes with rare variants that affect diabetes risk. The research includes data from people of European, African American, Hispanic/Latino, East Asian, and South Asian ancestries. "These results demonstrate the importance of studying large samples of individuals from a wide range of ancestries," said senior study author Michael Boehnke, professor of biostatistics and director of the Center for Statistical Genetics at the University of Michigan School of Public Health. "Most large population studies focus on individuals of European ancestry, and that can make it hard to generalize the results globally. The more diverse the cohort makes for better, more informative science." Jason Flannick, first author on the study and an assistant professor of pediatrics at Harvard Medical School and the Division of Genetics and Genomics at Boston Children's Hospital, added: "These rare variants potentially provide a much more valuable resource for drug development than previously thought. We can actually detect evidence of their disease association in many genes that could be targeted by new medications or studied to understand the fundamental processes underlying disease." The researchers' findings are publicly available online through the Type 2 Diabetes Knowledge Portal. (Click for more...) Trends in levels of lipids and apolipoprotein B in U.S. youth 5/23/2019 4:05:01 PM Trends in levels of lipids and apolipoprotein B in U.S. youth Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 New research shows favorable trends in levels of lipids and apolipoprotein B in American youth in recent years. The serial cross-sectional analysis looked at U.S. population–weighted data for youth aged 6–19 years from the National Health and Nutrition Examination Surveys for 1999 through 2016. The researchers noted decreasing linear trends in mean levels of total cholesterol, non–high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and apolipoprotein B over the study period. Increasing linear trends were noted for mean levels of HDL cholesterol. Still, the researchers note that at the end of the study period, 19%–25% of the youth had at least one adverse level and only 47%–51% had all lipids at ideal levels. According to the authors, "It will be important to understand the reasons for the favorable lipid trends observed in this study to both acknowledge public health successes and plan future efforts." (Click for more...) Unique initiative to lower drug prices signs manufacturer 5/23/2019 4:05:01 PM Unique initiative to lower drug prices signs manufacturer Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 Civica announced a contract with Xellia Pharmaceutical, a Copenhagen drug company with manufacturing plants in the United States, to produce vancomycin and daptomycin used in the I.V. treatment of antibiotic-resistant infections. The generic drugs are the first two announced by Civica as part of a unique initiative that it launched last year to work directly with partner hospitals to identify needed medications that are often in short supply. Civica says the process is designed to help bring down cost as scare drugs can drive prices to "artificially high" levels. The two antibiotics should be available to member hospitals by the end of the summer. Civica hopes to deliver 14 drugs by 2020. About 900 hospitals have joined with Civica. (Click for more...) Doctors can estimate patient adherence by simply asking about medication routine 5/23/2019 4:05:01 PM Doctors can estimate patient adherence by simply asking about medication routine Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 A study in the Journal of General Internal Medicine says physicians were as likely to accurately estimate patients' adherence to medication from their descriptions of their medicine routines as by patients' direct reports of missed medication. Researchers asked patients to describe their daily routine for taking medication and to recall how many days during the last week they missed a dose. Researchers used a medication monitoring system to track compliance for the following month. The system attached to a medicine bottle and recorded the date and time when the bottle was opened. Of 156 patients, 75 took tablets for hypertension, and the other 81 were on medication for type 2 diabetes. Patients' own estimates of their medication-taking routines were shared with doctors, whose estimates were compared with adherence rates calculated by the monitoring system. Study co-author Alison Phillips, an associate professor of psychology at Iowa State University, intends to build upon the research by designing and testing interventions for doctors to share with patients they identify as less likely to adhere. Phillips says there are several reasons why patients do not take their medications, such as cost, access, and not trusting medications. Phillips adds: "Habit-focused interventions would target those who forget to regularly take their pills versus those who consciously decide not to take their pills. Still, if doctors ask about routines it may reveal other barriers they need to consider when prescribing medication." (Click for more...) Express Scripts plans formulary for apps, medical devices 5/23/2019 4:05:01 PM Express Scripts plans formulary for apps, medical devices Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 Express Scripts announced that it will launch a digital health formulary in 2020. The formulary will feature a list of digital health tools, including smartphone apps and software-enabled medical devices, to help patients manage their health. The company notes that Express Scripts clients will stlil be able to select which digital tools they will provide for members. The list will be curated by pharmacists, physicians, and others. "Much of this technology is still emerging, and there are many digital health solutions that require clinical review and validation," Mark Bini, Express Scripts VP of innovation and member experience, said in a statement. "We see a need to put mechanisms in place to help carefully manage these innovations." Express Scripts says its formulary will include digital health solutions for a host of chronic and complex conditions, including diabetes, cardiovascular, pulmonary and behavioral health issues. (Click for more...) New Colorado law caps monthly insulin copays at $100 5/23/2019 4:05:01 PM New Colorado law caps monthly insulin copays at $100 Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 Gov. Jared Polis of Colorado on Wednesday signed into law a bill that will cap monthly insulin copays at $100 for people with diabetes. Rep. Dylan Roberts (D-Avon), the prime sponsor of the legislation, says 25% of people with diabetes have been rationing insulin. "For Coloradans living with Type 1 diabetes, insulin is essential to their survival—it's the same as oxygen," says Roberts. "The skyrocketing cost of insulin is outrageous and it is literally putting people’s lives at risk." Roberts notes he was able to get the cooperation of health insurers in getting the measure through the legislature this year. He says part of the problem is only three multinational companies make insulin—and their prices have gone up almost in tandem in recent years, even though the cost of production has not changed. The also authorizes the state attorney general's office to investigate drug pricing, manufacturers, and PBMs. (Click for more...) Federal judge enters consent decree against compounder PharMedium Services 5/23/2019 4:05:01 PM Federal judge enters consent decree against compounder PharMedium Services Wed, 05/22/2019 - 20:00 cbaker_admin Thu, 05/23/2019 - 16:05 A U.S. district court judge, Virginia M. Kendall for the Northern District of Illinois, has entered a consent decree of permanent injunction between the United States and PharMedium Services and two company officials. The company, based in Lake Forest, IL, has four registered outsourcing facilities around the United States. The complaint holds that despite warnings from FDA and repeated promises from PharMedium to correct deficiencies, the company continued to violate the law. "PharMedium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable," said Acting FDA Commissioner Ned Sharpless, MD. Under the consent decree, PharMedium and the other defendants are prohibited from manufacturing, holding, or distributing the company's drugs at or from its Tennessee facility until it completes corrective actions and receives FDA authorization. Operations have already been halted at PharMedium's Mississippi facility, while its facilities in Texas and New Jersey must hire an independent expert to review operations to ensure compliance with the law. The government's complaint asserts that PharMedium manufactured and distributed drugs intended to be sterile, such as oxytocin and morphine sulfate, that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Additionally, the complaint alleges that PharMedium distributed unapproved new drugs and drugs that were misbranded because their labeling did not include adequate directions for use. (Click for more...) GSK tweaks ethics-based rep compensation rules to recruit and retain talent 5/23/2019 11:40:54 AM GlaxoSmithKline has the strictest sales pay rules in the industry, thanks to changes it made over the last several years to improve ethics and transparency. But it's loosening up. As of Thursday, the company will allow specialty salespeople to take home bigger paychecks. (Click for more...) Want bang for your buck? Don't look to Sarepta's pricey DMD therapy Exondys, ICER says 5/23/2019 10:31:14 AM As far as troubled backstories go, Sarepta Therapeutics’ Exondys 51 has a doozy with a contentious approval process and a major insurer backing away from the targeted therapy. Now the pricey Duchenne muscle dystrophy (DMD) treatment has a new problem: An influential gatekeeper says it simply isn’t cost-effective. (Click for more...) Daiichi Sankyo looking to sell OTC business for $900M? 'Not correct,' says company 5/23/2019 9:31:11 AM Is Daiichi Sankyo following in several Big Pharma companies’ footsteps out the consumer healthcare door? That's the word on the street. But according to the company, the answer is "no." (Click for more...) J&J's Invokana closes in on badly needed kidney disease nod with FDA 'priority' boost 5/23/2019 9:22:14 AM When it comes to Invokana sales, Johnson & Johnson needs a way to stop the bleeding. And it just got one step closer to a new indication in chronic kidney disease—a distinction its rival SGLT2 drugs don't have. (Click for more...) Novartis CEO says Zolgensma won't cost anywhere near the $4M to $5M once quoted 5/23/2019 9:11:16 AM Novartis made headlines last year by saying its forthcoming spinal muscular atrophy gene therapy could be cost-effective at up to $5 million. Now, its CEO says the price will be "far lower" than that range. (Click for more...) Boehringer Ingelheim plans 3-year, $84M expansion in Mexico 5/23/2019 8:04:53 AM Boehringer Ingelheim intends to make a significant investment in its three manufacturing sites in Mexico in the next three years, starting with its site near Mexico City where it makes diabetes drugs. (Click for more...) CMA accuses four pharmas of anticompetitive behaviour 5/23/2019 5:44:00 AM Four pharma companies stand accused in the UK of colluding to artificially inflate the price of prescription-only, anti-nausea and dizziness drug prochlorperazine, costing the NHS millions of pounds and breaking competition law. (Click for more...) Scancell, CR UK publish joint vaccine update 5/23/2019 5:06:28 AM SCIB2 is to be administered using a new nanoparticle formulation in a planned Phase I/II clinical trial. (Click for more...) Vulnerable children stuck in mental health hospitals for too long 5/23/2019 5:04:38 AM Too many children are being admitted to secure hospitals unnecessarily, and in some cases are spending months and years of their childhood in institutions. (Click for more...) New data highlights value of Janssen’s Spravato 5/23/2019 5:03:44 AM The approval of the drug is a new way of treating adults with TRD that is unlike other treatment options in psychiatry. (Click for more...) Insilico, ARK initiate health-span and longevity partnership 5/23/2019 5:03:07 AM The newly developed ‘ARK’ will develop a programme of events to facilitate networking in AI research across King’s. (Click for more...) WVU Cell & Molecular Biology and Biomedical Engineering Training Program 5/23/2019 12:00:00 AM WVU Cell & Molecular Biology and Biomedical Engineering Training Program (CBTP) (Click for more...) Dendreon commits to prostate cancer vaccine Provenge with new lease for manufacturing site 5/22/2019 10:03:04 PM Dendreon, which last summer changed ownership for a third time in as many years, signaled its faith in prostate drug Provenge by signing a lease extension for its Seal Beach, California, manufacturing facility and headquarters. (Click for more...) 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes 5/22/2019 8:00:00 PM Drug: 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes, Revision Date: Thu, 23 May 2019 (Click for more...) 25% Dextrose Injection 5/22/2019 8:00:00 PM Drug: 25% Dextrose Injection, Revision Date: Thu, 23 May 2019 (Click for more...) 50% Dextrose Injection 5/22/2019 8:00:00 PM Drug: 50% Dextrose Injection, Revision Date: Thu, 23 May 2019 (Click for more...) Fentanyl Citrate Injection 5/22/2019 8:00:00 PM Drug: Fentanyl Citrate Injection, Revision Date: Thu, 23 May 2019 (Click for more...) Indomethacin Capsules 5/22/2019 8:00:00 PM Drug: Indomethacin Capsules, Revision Date: Thu, 23 May 2019 (Click for more...) Magnesium Sulfate Injection 5/22/2019 8:00:00 PM Drug: Magnesium Sulfate Injection, Revision Date: Thu, 23 May 2019 (Click for more...) Nitrofurantoin Oral Suspension 5/22/2019 8:00:00 PM Drug: Nitrofurantoin Oral Suspension, Revision Date: Thu, 23 May 2019 (Click for more...) Vitamin K (Phytonadione) Injection 5/22/2019 8:00:00 PM Drug: Vitamin K (Phytonadione) Injection, Revision Date: Thu, 23 May 2019 (Click for more...) Lilly selling one-half-price version of popular insulin 5/22/2019 3:05:01 PM Lilly selling one-half-price version of popular insulin Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 Eli Lilly is now selling a one-half-price version of its insulin lispro recombinant (Humalog), following the company's promise in March to offer diabetics a more affordable option. The drugmaker said insulin lispro will cost $137.35 per vial, or $265.20 for a package of five KwikPens, an easier-to-inject option. The fast-acting insulin, which diabetics inject shortly before each meal, is used by approximately 700,000 Americans. Lilly said the biggest savings will go to patients who are uninsured, have high-deductible health insurance, or have Medicare Part D plans. Because insulin lispro is identical to Humalog, pharmacists will be able to substitute the half-price generic. (Click for more...) Out-of-pocket costs for MS, other neurology meds, soar 5/22/2019 3:05:01 PM Out-of-pocket costs for MS, other neurology meds, soar Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 A new study in Neurology indicates that out-of-pocket costs for medications used to treat neurologic diseases such as multiple sclerosis (MS), Parkinson disease (PD), peripheral neuropathy, epilepsy, and dementia have increased exponentially over the past 13 years. Researchers accessed a database of de-identified patient information for 73 million United Healthcare subscribers to evaluate the five most commonly prescribed medications for each condition, in addition to certain other high-cost treatments. The median monthly out-of-pocket cost for eight MS medications increased from $14 in 2004 to $59 in 2016, while monthly out-of-pocket and totals costs for many epilepsy agents remained stable during that period. Carbamazepine was an exception, with rising costs between 2014 and 2016. When investigators evaluated how high-deductible insurance plans contributed to patient costs, they found that for patients with MS and a high-deductible insurance plan, monthly out-of-pocket costs were $661 in 2016, compared with $246 for those not in high-deductible health plans. The investigators called on neurologists to have better patient-specific information about medication costs at the point-of-care. (Click for more...) NCPA Foundation, AmerisourceBergen Foundation to support pharmacies during disasters 5/22/2019 3:05:01 PM NCPA Foundation, AmerisourceBergen Foundation to support pharmacies during disasters Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 The nonprofit AmerisourceBergen Foundation is partnering with the National Community Pharmacists Association (NCPA) to ensure community pharmacies affected by natural disasters and other emergencies can continue to support patient populations. The AmerisourceBergen Foundation has donated to the NCPA Foundation to create the AmerisourceBergen Foundation–NCPA Foundation Disaster Relief Grant Fund. The fund will be administered by the NCPA Foundation, including decisions related to eligibility and grant selections. The fund will provide financial assistance to community pharmacy owners for the repair of pharmacies in the event of disasters, accidents, illness, or other adverse circumstances. A community pharmacy experiencing hardship due to flooding, fire and smoke damage, winter storm damage, or other damage will be eligible for grants. (Click for more...) Survey finds student pharmacists have high awareness of PrEP but gaps remain 5/22/2019 3:05:01 PM Survey finds student pharmacists have high awareness of PrEP but gaps remain Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 A study by researchers at the University of Buffalo estimates that 1.2 million people nationwide could benefit from HIV pre-exposure prophylaxis (PrEP), but just 100,000 take it. The researchers surveyed student pharmacists enrolled in a doctor of pharmacy academic training program at the University of Buffalo between October and November 2017, finding there was overall high awareness of PrEP (91%), and 61% reported high familiarity with PrEP prescription guidelines. However, only 55% of participants knew the daily dosing frequency and approved medication for PrEP (emtricitabine-tenofovir disoproxil fumarate [Truvada—Gilead Sciences]) and just 44.2% knew that HIV testing was required before prescribing the prevention medication. Meanwhile, 38% were aware of the recommended HIV testing frequency for patients taking PrEP and 28% knew that reduced creatine clearance was a contraindication to prescribing PrEP. The researchers wrote, "Our results indicate that educational efforts are needed not only to increase PrEP awareness, but also to improve knowledge of prescription guidelines, which can have a positive impact on broad patient education practices and PrEP dispensing." Some negative perceptions of the medication also emerged: 40% believed that widespread PrEP use would substantially increase rates of antiretroviral resistance and approximately 1 in 4 thought that sexual behavioral risks could increase among those taking the medication. (Click for more...) Former FDA chief Gottlieb: 'We struck the wrong balance' on e-cigarettes 5/22/2019 3:05:01 PM Former FDA chief Gottlieb: 'We struck the wrong balance' on e-cigarettes Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 FDA struck the wrong balance in its oversight of the e-cigarette industry, former FDA head Scott Gottlieb said Tuesday. While commissioner, Gottlieb championed e-cigarettes as a way to help adults stop smoking. The agency's delayed oversight has been blamed, in part, on a rise in teen vaping that Gottlieb eventually labeled an "epidemic." FDA called the top five manufacturers late last year to address the issue and moved up the deadline for manufacturers to apply to have their products reviewed by the agency by 1 year, which Gottlieb pushed back when he started as commissioner in 2017. A federal judge last week ruled that FDA needs to start accepting applications, saying the agency was abdicating its regulatory authority. Gottlieb on Tuesday said he agrees that the applications should be submitted earlier. Gottlieb called the decision a "bad ruling" and said he worried about the precedent it would set. However, Gottlieb said he considered removing nicotine pods used for vaping, and popularized by Juul, from the market when he was FDA commissioner. "We were looking to move towards putting those products in earlier anyway. Now whether or not this judge's ruling provides the impetus for the agency to go in and do that now as opposed to waiting, I don't know what decision they're going to make,” Gottlieb said. "If I was there, I would certainly consider taking that action now in review of this judge’s ruling." (Click for more...) To slash prices, Colorado moves to import Canada's prescription drugs 5/22/2019 3:05:01 PM To slash prices, Colorado moves to import Canada's prescription drugs Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 Gov. Jared Polis of Colorado has signed legislation that would permit the importation of prescription drugs from Canada. Under the law, the Colorado Department of Health Care Policy and Financing is charged with the creation of plan to safely import Canadian drugs and to present a proposal to HHS by September 2020. "As a pharmacist, I know there are many Coloradans who are having to choose between feeding their families or the life-saving drugs they depend on," said Rep. Jaquez Lewis, a Boulder-area Democrat who sponsored the bill. "We've seen drug price increases of nearly 500%. That's unacceptable, and those prices are drowning patients." There is no guarantee, however, that HHS will approve the state's proposal, and some are skeptical that importing drugs will affect drug prices. (Click for more...) FDA chief of staff calls OTC monograph reform a top priority 5/22/2019 3:05:01 PM FDA chief of staff calls OTC monograph reform a top priority Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 FDA Chief of Staff Lauren Silvis says the agency is dedicated to increasing access to safe and effective nonprescription drugs. Speaking Tuesday at the Consumer Healthcare Products Association's Regulatory, Scientific, and Quality Conference, Silvis said: "On the monograph side, I want to make clear today that OTC monograph reform remains a top priority for the agency." She noted, however, that "it's up to Congress to legislate on this issue." In terms of nonprescription new drug application (NDA) products, Silvis explained FDA is "pushing forward" with its nonprescription safe use regulatory expansion (NSURE) initiative to encourage prescription to nonprescription switches. Additionally, she said FDA is working to address the issue of how to ensure a medication can be used safely and effectively in a nonprescription setting when a traditional drug facts label is not sufficient to ensure safe use. According to Silvis, as a result of the reorganization of FDA's Office of New Drugs, the agency's "subject matter experts will have more time, better analytic tools, and more knowledge management support to advance the clinical and regulatory principles we rely on to evaluate the safety and efficacy of innovative products, including innovative approaches for OTC products." (Click for more...) Supreme Court sends dispute over alendronate back to lower court 5/22/2019 3:05:01 PM Supreme Court sends dispute over alendronate back to lower court Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 In the case Merck Sharp & Dohme Corp. v. Albrecht, all nine Supreme Court justices agreed that the case should go back to a lower court for further proceedings. The justices said the question of whether the case can move forward should be decided by a judge, not a jury. The case involves users of alendronate (Fosamax—Merck & Co.), which is prescribed to treat osteoporosis in women who have gone through menopause. These patients said Merck failed to provide sufficient warnings of a specific risk of bone fracture on the drug's label. A trial court initially dismissed the claims against the New Jersey-based company, but an appeals court restored them. The Supreme Court says that if a judge finds clear evidence Merck told federal regulators about the reasons for a warning and that warning was rejected by regulators, the case should be dismissed. David Frederick, a lawyer for the patients, says the court's ruling "protects access to justice for injured patients." Merck said in a statement that it "will continue to present evidence that it acted appropriately at all times" in warning about the potential risk of the fractures. (Click for more...) Oklahoma governor signs revised pharmacy choice bill 5/22/2019 3:05:01 PM Oklahoma governor signs revised pharmacy choice bill Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 Gov. Kevin Stitt of Oklahoma on Tuesday signed a revised pharmacy choice bill into law, 3 weeks after vetoing an earlier version. House Bill 2632 prohibits restrictions on a patient's right to choose a pharmacy provider without paying a penalty and calls for an advisory committee to review complaints and administer fines. In his veto message, Stitt said SB 841 attempted to regulate certain health plans in a way that is not allowed by federal law. The governor called on the Legislature to develop a compromise on the issue. "We fixed the issue to the governor's satisfaction," said HB 2632's author, Rep. Jon Echols (R-Oklahoma City). The pharmacy choice bills were written to regulate pharmacy PBMs. Opponent, urged the governor to veto both bills, predicting that prescription drug costs will increase for Oklahoma families. A House fiscal impact analysis shows the cost to the state in increased prescription drug costs would be $7.2 million annually, and the cost of staff to regulate the law would be at least $350,000 annually. (Click for more...) Cancer death rates drop, heart disease deaths on the rise for U.S. adults 5/22/2019 3:05:01 PM Cancer death rates drop, heart disease deaths on the rise for U.S. adults Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 From 1999 to 2017, cancer deaths among adults aged 45–64 years in the United States declined 19%, according to CDC. Researchers from the agency's National Center for Health Statistics also found that deaths from heart disease among this age group fell 22% from 1999 to 2011, though they increased by 4% from then to 2017. Rates of death from cancer were higher than those for heart disease during the study period. Men and women saw a similar pattern of overall decline in cancer deaths and recent increases in deaths from heart disease. CDC said that cancer and heart disease are the leading causes of death for people in this age group, accounting for roughly one-half of all deaths among middle-aged Americans. (Click for more...) Nintedanib for systemic sclerosis-associated interstitial lung disease 5/22/2019 3:05:01 PM Nintedanib for systemic sclerosis-associated interstitial lung disease Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 The SENSCIS trial examined the effect of nintedanib in the setting of interstitial lung disease (ILD), which is implicated in systemic sclerosis-associated morbidity and mortality. A sample of 576 ILD patients who met the study criteria were randomly divided into a control group and an intervention group. The active-treatment patients received twice-daily oral nintedanib, which has demonstrated anti-fibrotic and anti-inflammatory properties against systemic sclerosis and ILD. At followup 1 year later, the adjusted annual rate of decrease in forced vital capacity (FVC) was 52.4 mL among patients taking nintedanib compared with 93.3 mL for patients receiving placebo. Although the annual rate of decline in FVC was lower with nintedanib, the agent offered no other clinical benefit over placebo in this patient population. Moreover, nintedanib recipients were more likely than controls to experience gastrointestinal adverse events. Diarrhea, for example, affected 75.7% of those in the intervention group but only 31.6% of the placebo recipients. (Click for more...) Benralizumab for the prevention of COPD exacerbations 5/22/2019 3:05:01 PM Benralizumab for the prevention of COPD exacerbations Tue, 05/21/2019 - 20:00 cbaker_admin Wed, 05/22/2019 - 15:05 The GALATHEA and TERRANOVA studies questioned whether benralizumab could safely and effectively avert exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Enrollees included COPD patients with high blood esinophil counts, who continued to suffer frequent exacerbations despite inhaler therapy. The participants were randomized to various doses of the study drug or to placebo, with followup at week 56 to determine the annual rates of COPD exacerbation with benralizumab and with placebo. Benralizumab as an adjunct to inhaled treatment failed to reduce the annualized rate of these events, relative to placebo, in patients with moderate to very severe COPD, a history of frequent or severe exacerbations, and blood esinophil counts of 220 per cubic millimeter or higher. (Click for more...) KCL findings could improve STI vaccines 5/22/2019 11:16:05 AM Researchers have shown how skin vaccination can generate protective CD8 T-cells that are recruited to the genital tissues. (Click for more...) Cegedim, Sanofi enter healthcare improvement RWD collaboration 5/22/2019 11:15:36 AM The company will provide Sanofi with information going back to 1994. (Click for more...) Nintedanib hits targets in rare lung disease trial 5/22/2019 11:15:08 AM The drug was successful in patients with systemic sclerosis associated interstitial lung disease. (Click for more...) The future of GP care lies with ‘micro-teams’ 5/22/2019 11:14:37 AM The current regimen has been declared “unfit for purpose” by Professor Helen Stokes-Lampard. (Click for more...) Array's ‘extremely compelling’ new colon cancer data spark blockbuster talk 5/22/2019 10:49:17 AM Array Biopharma saw its shares soar on interim data for its three-part therapy in BRAF-positive colon cancer. But analysts say the company still needs to prove that the therapy is safe and that its benefits are durable. (Click for more...) Lilly to insulin pricing critics: Check out our 50%-off Humalog copy instead 5/22/2019 10:01:36 AM With Congress railing against rising list prices for insulin, Eli Lilly made a commitment to introduce a cheaper generic version of its Humalog in a show of good faith. Consider that a promise kept. (Click for more...) Daiichi Sankyo comes up far short of promised avian flu vaccine production 5/22/2019 9:54:13 AM Daiichi Sankyo is apologizing to the Japanese people. The drugmaker is sorry for again missing a deadline to manufacture enough bird flu vaccine to help protect the country in case of an epidemic. It is still coming up far short of being able to produce within six months enough doses to vaccinate 40 million people. (Click for more...) 2019–20 APhA–ASP Standing Committees 5/22/2019 9:39:05 AM 2019–20 APhA–ASP Standing Committees Thu, 05/23/2019 - 13:00 cbaker_admin Wed, 05/22/2019 - 09:39 Awards Standing Committee Michael Behal (Chair) The University of Tennessee Jaspreet Bhullar Long Island University Cortni Hicks University of Arkansas for Medical Sciences Tessa Schnell...Only allowed members have full access to this content.Log in to view full content. (Click for more...) J&J's good news, bad news day in talc court yields win in South Carolina, $25M loss in New York 5/22/2019 9:24:21 AM As Johnson & Johnson continues to defend itself against allegations its talc powders can cause cancer, the company prevailed in a South Carolina trial and lost in New York on Tuesday. (Click for more...) GlaxoSmithKline's booming Shingrix, after VIP invite, wins nod to tackle China 5/22/2019 9:19:03 AM GlaxoSmithKline’s shingles vaccine Shingrix has continuously impressed industry watchers with its explosive growth. Now, the company has added another large market to its list: China. (Click for more...) 5% Dextrose Injection (PVC-free and DEHP-free) 5/21/2019 8:00:00 PM Drug: 5% Dextrose Injection (PVC-free and DEHP-free), Revision Date: Wed, 22 May 2019 (Click for more...) Asparaginase Erwinia chrysanthemi 5/21/2019 8:00:00 PM Drug: Asparaginase Erwinia chrysanthemi, Revision Date: Wed, 22 May 2019 (Click for more...) Azithromycin Injection 5/21/2019 8:00:00 PM Drug: Azithromycin Injection, Revision Date: Wed, 22 May 2019 (Click for more...) Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection 5/21/2019 8:00:00 PM Drug: Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection, Revision Date: Wed, 22 May 2019 (Click for more...) Hepatitis B Vaccine (Recombinant) 5/21/2019 8:00:00 PM Drug: Hepatitis B Vaccine (Recombinant), Revision Date: Wed, 22 May 2019 (Click for more...) Hypromellose Ophthalmic Solution 5/21/2019 8:00:00 PM Drug: Hypromellose Ophthalmic Solution, Revision Date: Wed, 22 May 2019 (Click for more...) Metronidazole Hydrochloride Injection 5/21/2019 8:00:00 PM Drug: Metronidazole Hydrochloride Injection, Revision Date: Wed, 22 May 2019 (Click for more...) Rosuvastatin Calcium Tablets 5/21/2019 8:00:00 PM Drug: Rosuvastatin Calcium Tablets, Revision Date: Wed, 22 May 2019 (Click for more...) Sodium Polystyrene Sulfonate Oral or Rectal Suspension 5/21/2019 8:00:00 PM Drug: Sodium Polystyrene Sulfonate Oral or Rectal Suspension, Revision Date: Wed, 22 May 2019 (Click for more...) Spironolactone Tablets 5/21/2019 8:00:00 PM Drug: Spironolactone Tablets, Revision Date: Wed, 22 May 2019 (Click for more...) Temazepam Capsules 5/21/2019 8:00:00 PM Drug: Temazepam Capsules, Revision Date: Wed, 22 May 2019 (Click for more...) Valsartan Tablets 5/21/2019 8:00:00 PM Drug: Valsartan Tablets, Revision Date: Wed, 22 May 2019 (Click for more...) Methylphenidate Extended-Release Oral Suspension and Chewable Tablets 5/21/2019 8:00:00 PM Drug: Methylphenidate Extended-Release Oral Suspension and Chewable Tablets, Revision Date: Wed, 22 May 2019 (Click for more...) Hepatitis A outbreak declared by PA health officials 5/21/2019 2:05:01 PM Hepatitis A outbreak declared by PA health officials Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 Pennsylvania health officials declared on Monday an outbreak of hepatitis A. The designation, which will make additional resources available, follows the diagnosis of 171 cases of hepatitis A in the state since January 2018. Several neighboring states have also recorded cases of the disease, while Ohio and Kentucky have each recorded about 2,000 cases of hepatitis A. According to a state health department spokesperson, the decision to declare an outbreak will use the outbreak determination to provide additional funding for mass vaccination efforts and other resources, should they be needed. Health department data show that about 3–10 cases of hepatitis A were reported each month from January 2018 to August 2018. Since that time, the number of new cases reported each month has increased to 10–15. The spokesperson noted that cases of hepatitis A are being seen in specific groups, with people who use illegal drugs and use needles to inject drugs, and those who are homeless considered at risk. (Click for more...) Lilly's promising drug for breast cancer runs into problems in Japan 5/21/2019 2:05:01 PM Lilly's promising drug for breast cancer runs into problems in Japan Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 The Japanese health ministry on May 17 warned that Eli Lilly's drug abemaciclib (Verzenio), a treatment for metastatic breast cancer, is suspected of adversely affecting patients’ lungs, after 14 recipients in Japan developed a serious lung disease and 3 died. The drug is suspected of causing that problem in at least 4 of the 14 cases, including 1 fatality, the ministry said. Lilly said Monday it has updated the label for abemaciclib in Japan to include a new warning following reports of the adverse drug reactions there. The updated label warns of the risk of interstitial lung disease/pneumonitis, a group of disorders that cause scarring of the lungs and can make it difficult to breathe for some people. "It is known to be more frequently observed in an East Asian population, and the majority of cases reported for the drug worldwide have been in Japan," Lilly said. "The reason for higher incidence of noninfectious pneumonitis in this population is not fully understood, though differences in genetic sensitivity may play a role." Lilly began selling abemaciclib in Japan in November, 2 months after getting regulatory clearance there. More than 2,000 patients in Japan have used the drug since then. A major setback with abemaciclib could chip away at Lilly’s aggressive push into oncology, potentially a huge growth area. (Click for more...) Early sedation with dexmedetomidine in critically ill patients 5/21/2019 2:05:01 PM Early sedation with dexmedetomidine in critically ill patients Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 Researchers designed a randomized clinical trial to learn more about the use of dexmedetomidine in the intensive care unit, where it has shown potential in shortening the duration of mechanical ventilation and curtailing delirium. The study population included critically ill adults who had been on ventilation for no more than 12 hours but were expected to remain on it for at least 12 months. A total of 4,000 patients were enrolled, 3,904 of whom were included in the modified intent-to-treat population. About one-half received dexmedetomidine as the primary or only sedative for mechanical ventilation, while the remainder received standard care consisting of propofol, midazolam, or other sedatives. The 90-day, any-cause mortality rate was the same for both treatment arms: 29.1%. However, about three-quarters of the patients assigned to dexmedetomidine needed supplemental sedatives to achieve the desired level of sedation. In addition, the dexmedetomidine patients reported bradycardia and hypotension more often than did patients who received usual care. (Click for more...) Controlled trial of budesonide-formoterol as needed for mild asthma 5/21/2019 2:05:01 PM Controlled trial of budesonide-formoterol as needed for mild asthma Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 The Novel START clinical study compared different strategies for preventing exacerbations in adults with mild asthma. Participants were randomized to albuterol as needed, daily maintenance with budesonide plus albuterol as needed, or budesonide-formoterol as needed. The primary outcome, as measured by electronic monitoring of inhalers, was the rate of asthma exacerbations over the course of 1 year. Based on results from 668 patients, the annualized exacerbation rate with budesonide-formoterol was lower than that with albuterol but about the same as that with maintenance therapy. The number of severe exacerbations, meanwhile, was lower in the budesonide–formoterol group than in either of the other two treatment arms. The findings indicate that budesonide-formoterol, used as necessary, may provide more effective prophylaxis against asthma exacerbations than albuterol as needed. (Click for more...) 'Hundreds' of CVS Pharmacy stores to get SmileDirectClub shops 5/21/2019 2:05:01 PM 'Hundreds' of CVS Pharmacy stores to get SmileDirectClub shops Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 CVS Health announced recently that it will devote sections of "hundreds" of CVS Pharmacy stores to SmileDirectClub’s braces alternative later this year after a pilot delivered promising results. The move continues the community pharmacy chain's strategy of shifting more floor space to health care services while cutting back on poorly selling products like greeting cards. Customers will be able to start their SmileDirectClub treatment plan in stores by getting their teeth scanned and signing up for plastic teeth aligners. SmileDirectClub patients then receive aligners in shipments to their homes after their cases are reviewed remotely by an orthodontist or dentist. CVS stores will devote "a very private environment in the back of the store" to the SmileDirectClub space, much like its MinuteClinic service for basic medical care, said CVS Pharmacy President Kevin Hourican, adding that d the 13-store pilot showed that CVS will gain customers who previously would not have shopped there. "We’re pleasantly surprised by the traffic that it’s driving," he said. (Click for more...) Opioid prescriptions drop sharply among state workers 5/21/2019 2:05:01 PM Opioid prescriptions drop sharply among state workers Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 The California Public Employees' Retirement System (CalPERS), which oversees health care benefits for California's state workers, is reporting a major reduction in opioid prescriptions. Insurance claims for opioid analgesics decreased nearly 19% in a single year among the 1.5 million Californians served by CalPERS. The number of new users who were prescribed large doses of opioid analgesics declined 85% in the first 6 months of 2018 compared with the same period in 2017, and new users prescribed more than a week's supply declined by 73%, according to new CalPERS data. OptumRx, which serves as CalPERS' PBM, adopted a policy in 2017 that includes limits on the quantity of opioids prescribed and mandates prior authorization for certain medications. However, CalPERS members are still being prescribed considerable volumes of opioids. For example, 34,321 patients were prescribed the drugs in the first half of 2018, of whom 1,168 were prescribed doses deemed large—exceeding the equivalent of 50 morphine milligrams per day. Kathy Donneson, chief of CalPERS' Health Plan Administration Division, says ideally patients with many types of chronic pain, such as knee or back pain, can be "kept pain-free in other ways" and opioids can be reserved for patients with cancer, in hospice, or in post-surgery care. (Click for more...) Pharmacists prescribe food vouchers in fight against diabetes 5/21/2019 2:05:01 PM Pharmacists prescribe food vouchers in fight against diabetes Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 In Bellefontaine, OH, about 130 people with diabetes are participating in a pilot program in which they are prescribed produce. The program is funded by $200,000 from the state and a federal Preventive Health and Health Services block grant. It provides approximately $30 a month per household member, to be only used for produce. The produce vouchers, viewed as prescriptions, became available in February and will be issued through November. Community Health and Wellness Partners, in Logan County, is one of two Ohio medical practices writing prescriptions for produce as a way to supplement traditional medicine. The state's other federally qualified health center participating in the program is Hopewell Health Centers in Athens County. At Community Health and Wellness Partners, pharmacist Jason Martinez also serves as a life coach for participants. He reviews their medications and may recommend lifestyle changes. "I honestly probably stop more medications than I start, which might seem counterintuitive," he says. "More often than not, I try to get rid of a medication, especially when we can pull in behavioral health." Participants also attend at least three 1-hour classes dealing with stress, yoga, exercise, and nutrition. (Click for more...) Citrus farmers facing deadly bacteria turn to antibiotics, alarming health officials 5/21/2019 2:05:01 PM Citrus farmers facing deadly bacteria turn to antibiotics, alarming health officials Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 Florida's citrus industry is being devastated by a bacterial infection transmitted by insects from China called huanglongbing, or citrus greening disease. To fight the disease, some growers are turning to antibiotics used by humans, which the Environmental Protection Agency (EPA) has been allowing since 2016. Antibiotics such as streptomycin and oxytetracycline can be used on an emergency basis. The EPA is now expanding its permitted use across 764,000 acres in California, Texas, and other citrus-producing states. The agency approved such expanded use despite objections from FDA and CDC, which warn that the heavy use of antimicrobial drugs in agriculture could spur germs to mutate. The EPA has proposed allowing as much as 650,000 pounds of streptomycin to be sprayed on citrus crops annually. Each year, Americans use 14,000 pounds of aminoglycosides, the class of antibiotics that includes streptomycin. The European Union has prohibited the agricultural use of both streptomycin and oxytetracycline, as has Brazil, where orange growers are combating huanglongbing as well. The use of antibiotics on citrus adds to the debate over whether the heavy use of antimicrobials in agriculture puts human health at greater risk by disabling the drugs' effectiveness. A great deal of that debate has focused on livestock farmers, who use 80% of antibiotics sold in the United States. (Click for more...) AAM Report: Generic savings totaled $293 billion in 2018 5/21/2019 2:05:01 PM AAM Report: Generic savings totaled $293 billion in 2018 Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 The U.S. health care system has saved $2 trillion in the last decade due to the availability of low-cost generics, according to the 11th annual edition of the Association for Accessible Medicine (AAM) 2019 Access & Savings Report. In 2018 alone, the health care system saved $293 billion due to low-cost generics. The report also found that Medicaid saved $46.8 billion in 2018 through the use of generics; generic medicines account for 90% of the prescriptions filled in the United States; and that California had the largest savings of any state. "The 2019 Access and Savings Report once again confirms that generics and biosimilars bring down overall health care costs," said AAM president and CEO Chip Davis. (Click for more...) J&J's new esketamine drug for depression not worth the money or the risk, watchdog says 5/21/2019 2:05:01 PM J&J's new esketamine drug for depression not worth the money or the risk, watchdog says Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 A report by the nonprofit Institute for Clinical and Economic Review (ICER) says esketamine (Spravato—Janssen Pharmaceuticals) may be overpriced for the benefits it delivers. Each treatment of the nasal spray costs $590–$885, which is not covered by most insurance companies and does not include a physician's time. Esketamine was approved by FDA in March for people with treatment-resistant depression (TRD). The regimen initially requires twice-weekly office visits that can take up to 90 minutes each. Dosing frequency is reduced to every 2 weeks or once weekly after 4 weeks. The report notes, "Even when covered by health insurance, out-of-pocket costs can remain considerable and may prevent access to those who may benefit from esketamine." ICER also writes that evidence of improvement after taking esketamine "is inadequate to completely exclude the possibility that harms may exceed benefits." The report said, "Given the lack of head-to-head trials and differences in study design, the evidence was insufficient to judge the net health benefit of esketamine versus ketamine, electroconvulsive therapy, transcranial magnetic stimulation, oral antidepressants, or augmentation with antipsychotics." Janssen contends that the report "underestimates the proven short- and long-term benefits that this treatment brings to TRD patients in need." The company also notes that treating TRD with ketamine is still regarded "as experimental" and comparing its use with esketamine is not valid. (Click for more...) Pharmacy groups react to new drug pricing rule 5/21/2019 2:05:01 PM Pharmacy groups react to new drug pricing rule Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 The National Association of Chain Drug Stores and the National Community Pharmacists Association have both expressed frustration with the new final rule from CMS relating to Medicare Advantage and Part D programs because it does not include DIR fee reform. "We are disappointed and frustrated that this final rule fails to finalize pharmacy DIR reform as proposed, to the detriment of seniors and community pharmacies," the organizations said in a joint statement. "Our organizations have been joined by many pharmacists, pharmacy stakeholder groups, patient advocacy organizations, patients, and members of Congress in advocating that all pharmacy price concessions be included at the point of sale—or eliminated altogether—to provide senior patients with lower costs and pharmacies with more certainty." DIR fees are misused by payers to claw back reimbursement to pharmacies for the prescription drugs that they provide to Medicare beneficiaries, according to the organizations. Penalties for pharmacies' alleged failure to achieve certain benchmarks have come because the benchmarks often are vague, undefined, inconsistent, unachievable or outside of the control of pharmacies. The organizations also said that misinterpretations of specific terms that are used in the Medicare program related to pharmacy reimbursement and drug pricing have led to these claw-backs, and ultimately to higher out-of-pocket drug costs for patients and increased costs for the government. (Click for more...) Measles outbreak now at 880 cases, with fastest growth still in New York 5/21/2019 2:05:01 PM Measles outbreak now at 880 cases, with fastest growth still in New York Mon, 05/20/2019 - 20:00 cbaker_admin Tue, 05/21/2019 - 14:05 CDC recorded 41 new cases of measles in the past week, bringing the total for this year's outbreak to 880. Thirty of the new cases were in New York state, especially in New York City and suburban Rockland County. Cases of measles have now been reported in 24 states. A CDC spokesperson noted that it is too early to determine whether the outbreak is slowing down. According to the spokesperson, an outbreak of geographically related measles cases is not considered to have ended until 42 days—two consecutive 21-day incubation periods—have passed without any new cases. Experts note that measles transmission often slows when warmer summer weather arrives, though it is not clear whether that is the result of children no longer being in close contact at school, families spending less time inside, or because virus-laden droplets stay airborne longer in cold, dry air than in warm, humid air. (Click for more...) New guideline on management of diabetes in older adults 5/21/2019 12:23:03 PM Primary Category: Focus on Diabetes CareKey point: The Endocrine Society released a clinical practice guideline on management of diabetes in older adults (≥65 y) that considers overall health and quality of life. The guideline, published in the Journal of Clinical Endocrinology and Metabolism, includes information on appropriate screening, lifestyle interventions, drug therapy, and management of comorbid conditions such as hypertension and dyslipidemia. Finer points: Diabetes affects approximately one-third of adults aged 65 years and older, and almost one-half of older adults meet the criteria for prediabetes. Therefore, appropriate identification and management of these patients are essential to reduce morbidity and mortality associated with uncontrolled diabetes. The Endocrine Society, in association with the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society, released a clinical practice guideline on management of diabetes in older adults. The guideline recommends that older adults without a diabetes diagnosis be screened by obtaining a fasting plasma glucose level or A1C. Those who meet the criteria for prediabetes should be further evaluated with a 2-hour oral glucose tolerance test. A specialist, such as an endocrinologist or diabetes care specialist, should manage adults with diabetes. These specialists should work with other providers and the patient to develop a treatment plan with patient-specific goals. Older adults should also be assessed for cognitive status, and those with cognitive impairment should have their medication regimens simplified and glycemic goals relaxed. In general, glycemic targets should be set to avoid hypoglycemia, especially in those receiving drugs that can cause hypoglycemia. Adults who are treated with insulin should have frequent fingerstick glucose monitoring or continuous glucose monitoring to assess glycemic status. Lifestyle modifications are recommended as initial management for older patients with type 2 diabetes. These include diets rich in protein and energy for frail adults and limiting the intake of simple sugars for those who are at risk for malnutrition. Metformin remains the initial drug of choice; however, older patients with impaired kidney function (i.e., creatinine clearance The blood pressure goal for most people with diabetes is less than 140/90 mm Hg. A lower goal can be considered for select patients, such as those who had a previous stroke or have progressing chronic kidney disease ( What you need to know: Diabetes is very prevalent among older adults, as are the complications of the disease. Clinicians should familiarize themselves with the new guideline, especially those involved in management of older patients with type 1 or 2 diabetes. One of the key aspects of the guideline is that treatment should be tailored to the overall health of the patient and his or her quality of life. Glycemic goals should consider patient characteristics such as comorbidities, impairments in activities of daily living, and cognitive status. Avoidance of hypoglycemia is also essential in older adults, and this adverse event can be avoided by closely monitoring patients and selecting safer drug regimens. What your patients need to know: Inform older adults with diabetes that newly published guidance emphasizes the role of lifestyle modifications and appropriate drug therapy to manage their condition. Educate older adults on proper nutrition, appropriate use of medications, potential adverse effects of prescribed treatments, and signs and symptoms of hypoglycemia. Sources: LeRoith D, et al. Treatment of diabetes in older adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104:1520–74. Primary Section Advisor: Charles D. PonteSecondary Category: Endocrinology (Click for more...) Education needed on proper application of facial moisturizer containing sunscreen 5/21/2019 12:01:59 PM Primary Category: OTC Medicines CornerKey point: According to a study published in PLoS One, when people used moisturizers that contain sunscreen, they were more likely to miss key areas of the face than when they applied traditional sunscreen products. Additional education is needed about covering the entire face when using moisturizers and other sun-protection strategies. Finer points: Sun exposure can lead to sunburn, skin spots, wrinkles, eye damage, and skin cancer. Proper protection against the sun with use of products that contain sun protection factors (SPFs) is essential. A prospective study was conducted in 84 participants to compare application of moisturizers that contain SPF with traditional sunscreen products to determine coverage achieved and protection afforded. Participants each had two visits in which they were exposed to UV radiation and photographed with a UV-sensitive camera before and after applying either a moisturizer with SPF or sunscreen. The opposite product was used on the second visit. The products contained the same primary active ingredient (titanium dioxide) and the same advertised SPF (i.e., SPF30). Participants were 18 to 57 years of age, and most (n = 62) were females. The comparison between sunscreen and SPF moisturizers showed that participants did worse when applying the moisturizer, missing greater areas of the face. The eyelid regions were frequently missed. Participants missed a mean of 16.6% of their face when applying moisturizer, compared with a mean of 11.1% when applying sunscreen (P P What you need to know: The current study highlights the need to educate people on proper application of products with SPF, whether these are daily moisturizers or traditional sunscreen products. A common missed area is the eyelid region (particularly the medial canthus area), so adequate protection of that area should be emphasized. Water-resistant products specific for the face containing zinc or titanium dioxide are good choices. People may need to try different products to find one that does not irritate the sensitive skin around the eyes and does not run in the eyes, causing burning and stinging when they sweat or swim. Not all sunscreens should be used around the eyes because they may be irritating if they get in the eyes. Good sunglasses that block UVA and UVB radiation also protect the eyelid area from sun exposure. Additional sun protection strategies should also be discussed and may include limiting exposure to the sun, especially between 10:00 am and 2:00 pm; wearing protective clothing to cover skin exposed to the sun, such as long-sleeve shirts, pants, and broad-brim hats; and regularly using broad-spectrum sunscreens with an SPF of at least 15 or higher. Instruct people to read the labels of sunscreen products to ensure they understand proper application, when to reapply, and if the products are water resistant. What your patients need to know: Educate people on the dangers of excessive sun exposure and strategies to protect themselves from the sun. For those primarily using moisturizers that contain sunscreen, educate them on proper application and the importance of protecting all areas of the face, including the eyelid regions. Sources: Lourenco EAJ, et al. Application of SPF moisturisers is inferior to sunscreens in coverage of facial and eyelid regions. PLoS One. 2019;14(4):e0212548. Primary Section Advisor: Tara Whetsel (Click for more...) Baltimore sues J&J for spinning up a 'sham' Zytiga patent to fend off generics 5/21/2019 11:30:43 AM Johnson & Johnson's blockbuster cancer drug Zytiga only recently lost its shield against generic competition, and according to a new lawsuit, that’s because J&J used underhanded tactics to keep copycat rivals at bay. (Click for more...) WuXi to build dedicated vaccine facility, but who's the client? 5/21/2019 10:43:33 AM WuXi Biologics says it will build a dedicated facility to manufacture a commercial vaccine product for a client in a contract that should produce $150 million a year for 20 years. It just didn’t say who the client is. (Click for more...) Supreme Court puts Merck's FDA preemption argument up for another review 5/21/2019 10:00:26 AM Merck's Fosamax fight has lasted for years—and thanks to the U.S. Supreme Court, Merck now gets another chance to press its case. But the case also centers on a question the entire pharma industry would like resolved: Whether FDA labeling decisions shield drugmakers from liability in state court. (Click for more...) See you in court: Mallinckrodt takes on feds to fight $600M in back Acthar rebates 5/21/2019 9:41:13 AM Mallinckrodt’s Acthar Gel is no stranger to controversy. Pricing critics, payers, and the feds have all targeted the controversial hormone injection. But now, Medicaid is hitting Acthar where it hurts most—in the pocketbook—and the company is more than happy to go to court. (Click for more...) Seattle Genetics taps pharma oncology veteran as first-ever chief commercial officer 5/21/2019 9:30:28 AM Now well on its way to becoming a multiproduct oncology company, Seattle Genetics has decided the time is right to bring in its first chief commercial officer. (Click for more...) How risky is benzodiazepine use in pregnancy? 5/21/2019 9:29:56 AM How risky is benzodiazepine use in pregnancy? Tue, 05/21/2019 - 09:35 ehaberkorn@aph… Tue, 05/21/2019 - 09:29 While previous research has linked pregnancy loss to this class of drugs, study researchers wanted to find out more about the exact risk of benzodiazepine use and miscarriage, which was defined as a pregnancy loss between the beginning of the sixth week and the 19th week of gestation. (Click for more...) Merck's powerhouse Keytruda whiffs breast cancer trial, delaying hopes for new use 5/21/2019 9:04:48 AM Right now, Roche’s Tecentriq is the only immuno-oncology drug approved in triple negative breast cancer. And thanks to a rare trial miss for Merck's superstar Keytruda, it looks like it’ll stay that way for awhile. (Click for more...) Catalent's new prize, Paragon, adding capacity to make Sarepta gene therapies 5/21/2019 8:37:25 AM Catalent now owns gene therapy CDMO Paragon Bioservices, and with the $1.2 billion deal it gets a new long-term manufacturing agreement with gene therapy biotech Sarepta. As part of that relationship come plans to expand manufacturing that will bring Paragon’s, and so Catalent’s, capacity to 425,000 square feet. (Click for more...) MSD’s Keytruda falls short in late stage breast cancer study 5/21/2019 8:00:54 AM The blockbuster drug did not meet its pre-specified primary endpoint of superior overall survival. (Click for more...) WVU Pharmacy Student in need of Help and Support 5/21/2019 12:00:00 AM One of our #pharmily members needs our help and support. in 2013, Anthony Berberich was diagnosed with Primary Sclerosing Cholangitis (LivingWithPSC.org), which is an autoimmune disease of the liver. His family recently shared that his condition has deteriorated to the end stage of liver disease and that he is in need of a liver transplant as soon as possible. Unfortunately, none of his immediate family meets the criteria to be a donor. They are searching for someone who is willing to share part of their liver (which does regrow) to save Anthony's life. The donor should be A+, A-, O+ or O-. They are asking people to share this information on their Facebook pages in the hopes of finding someone willing to help save Anthony's life. For those interested in learning more about being a donor you can speak confidentially with a transplant team member at the University of Pittsburgh Medical Center at 412.647.5800 or visit http://upmc.com/services/transplant/liver/living-donor (Click for more...) Dr. Sambamoorthi named interim chairperson for Department of Pharmaceutical Systems and Policy 5/21/2019 12:00:00 AM Professor Usha Sambamoorthi will be the interim chairperson for the Pharmaceutical Systems & Policy Department at the West Virginia University School of Pharmacy beginning in early June. School of Pharmacy Dean William Petros made the announcement this week. (Click for more...) Identifying Funding for Your Project - Looking Beyond Traditional Agencies 5/21/2019 12:00:00 AM The Office of Research and Graduate Education will be hosting an engaging session with the new Director of Corporate and Foundation Relations, Shelly Birdsong-Maddex. Shelly will join HSC faculty on behalf of the WVU Foundation to discuss partnerships and identifying funding opportunities beyond the traditional agencies. (Click for more...) Dean's List Spring 2019 5/21/2019 12:00:00 AM Dean's List Spring 2019 (Click for more...) Alumni Day Spring Seminar 5/21/2019 12:00:00 AM Activity is designed for pharmacists in all practice settings. The Alumni Day Seminar will focus on enhancing the wellbeing of you and your patients. Specific activities focus on insomnia, depression, repairing you and your patient's relationship with food and how breaking the diet rules can change your life, mindfulness and relieving stress, and understanding the differences between celiac disease and non-celiac disease. (Click for more...) Albuterol Inhalation Solution 5/20/2019 8:00:00 PM Drug: Albuterol Inhalation Solution, Revision Date: Tue, 21 May 2019 (Click for more...) Amino Acid Products 5/20/2019 8:00:00 PM Drug: Amino Acid Products, Revision Date: Tue, 21 May 2019 (Click for more...) Benztropine Mesylate Injection 5/20/2019 8:00:00 PM Drug: Benztropine Mesylate Injection, Revision Date: Tue, 21 May 2019 (Click for more...) Calcitriol Injection 5/20/2019 8:00:00 PM Drug: Calcitriol Injection, Revision Date: Tue, 21 May 2019 (Click for more...) Ceftriaxone Sodium Injection 5/20/2019 8:00:00 PM Drug: Ceftriaxone Sodium Injection, Revision Date: Tue, 21 May 2019 (Click for more...) Erythromycin Ophthalmic Ointment 5/20/2019 8:00:00 PM Drug: Erythromycin Ophthalmic Ointment, Revision Date: Tue, 21 May 2019 (Click for more...) Hydralazine injection 5/20/2019 8:00:00 PM Drug: Hydralazine injection, Revision Date: Tue, 21 May 2019 (Click for more...) Ketorolac Injection 5/20/2019 8:00:00 PM Drug: Ketorolac Injection, Revision Date: Tue, 21 May 2019 (Click for more...) Olanzapine Intramuscular Injection 5/20/2019 8:00:00 PM Drug: Olanzapine Intramuscular Injection, Revision Date: Tue, 21 May 2019 (Click for more...) 2% Lidocaine Hydrochloride Topical Jelly 5/20/2019 8:00:00 PM Drug: 2% Lidocaine Hydrochloride Topical Jelly, Revision Date: Tue, 21 May 2019 (Click for more...) Missouri continues as the last holdout on a statewide prescription drug monitoring program 5/20/2019 1:43:06 PM Missouri continues as the last holdout on a statewide prescription drug monitoring program Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 With its legislative session ending on May 17, Missouri continues to be the only state without a statewide prescription drug monitoring program. Gov. Mike Parson had pushed for it, but because of ongoing fears about privacy violations tangled up with gun control, the bill never got a full Senate vote. Missouri's cities, neighboring states, and the federal government have been forced to create a patchwork of workarounds. Currently, 72 jurisdictions have opted into St. Louis County's voluntary prescription drug monitoring system so pharmacists and doctors could check a patient’s other prescriptions. It now covers 84% of the state’s population. St. Joseph pharmacist JulieMarie Nickelson, a pharmacist at Rogers Pharmacy in the city of approximately 76,000 people, says the voluntary database means she no longer has to spend upward of 30 minutes on the phone tracking down whether a patient had prescriptions for drugs elsewhere. "It's really helpful to us as it makes it so we can make sure that patients aren’t taking medications that interact and can increase risk for an overdose," she says. "We just want to make sure our patients are safe, and we want to make sure medication that's not necessary doesn't get into the community." (Click for more...) Allergan wins lawsuit against Imprimis, jury awards only $48,500 5/20/2019 1:43:06 PM Allergan wins lawsuit against Imprimis, jury awards only $48,500 Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 A federal jury recently ordered Imprimis Pharmaceuticals to pay $48,500 in damages to Allergan for lost business due to false advertising by the compounding firm. The sum is far lower than the more than $7 million in lost profits that Allergan had requested in its lawsuit against Harrow Health Inc., formerly known as Imprimis Pharmaceuticals. Additionally, Allergan had requested up to $54 million in profit disgorgement. According to an SEC filing, the case found "the Company was liable for lost profit damages in the amount of forty-eight thousand five hundred dollars ($48,500) and zero dollars ($0.00) for disgorged profits." (Click for more...) B. Braun Medical to invest $1b to alleviate I.V. fluid shortages in the U.S. 5/20/2019 1:43:05 PM B. Braun Medical to invest $1b to alleviate I.V. fluid shortages in the U.S. Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 B. Braun Medical will invest $1 billion to build or expand facilities that produce I.V. fluids, with a goal of easing the nation's shortage. The Bethlehem, PA-based medical products manufacturer will build a new distribution facility in Daytona Beach, FL, and expand its facilities in Allentown, PA, and Irvine, CA. B. Braun will also expand two distribution facilities. The investment, called Solutions for Life, is the company's response to the shortage of I.V. fluids used in the health care system to hydrate patients, administer drugs, and replace lost blood volume. Maria Angela Karpf, MD, corporate vice president for B. Braun Medical, says: "In recent years, the U.S. market has seen destructive weather events and severe influenza seasons contributing to major nationwide I.V. fluid shortages. These shortages forced health care professionals and facilities to delay patient treatments or use alternate techniques." (Click for more...) Health officials seek to build vaccine stockpile to combat measles 5/20/2019 1:43:05 PM Health officials seek to build vaccine stockpile to combat measles Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 Measles was declared eliminated in 2000, yet the United States is on track to see an unprecedented number of cases this year. The nation's worst outbreak is occurring in New York City, but Illinois is one of a number of states with reported measles cases this year. Tom Hughes, executive director of the Illinois Public Health Association (IPHA), is in talks with health care providers, insurers, and vaccine distributors to curb the outbreak. Strategies include restarting a part of the state's Vaccines for Children (VFC) program, which in 2016 was discontinued for children enrolled in the state-funded Children's Health Insurance Plan (CHIP). IPHA is requesting $3 million to support a previous Illinois Department of Public Health grant to purchase and distribute vaccines, Hughes adds. CHIP children who used to rely on VFC vaccines now may, or may not, be getting their vaccines, he says. While health care providers still are reimbursed by the state for the costs of vaccinating CHIP children, some local health departments and pediatric doctors have stopped doing that because of the slow rate of state reimbursement and significant upfront costs of stockpiling vaccines. IPHA now seeks to partner with vaccine wholesalers and distributors, such as FFF Enterprises, to stock providers' shelves with vaccines. Hughes believes that with the discounts coming from the association's partnerships and bulk buying, the model will provide a long-term and sustainable supply of vaccines for providers statewide. (Click for more...) Charcoal toothpaste may do harm and not much good 5/20/2019 1:43:03 PM Charcoal toothpaste may do harm and not much good Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 Charcoal toothpaste is rising in popularity, but dentists warn these products might actually damage tooth enamel and make cavities more likely, according to a paper in the British Dental Journal. "The evidence highlighting any potential benefits of charcoal toothpaste over regular toothpaste is severely lacking," said Joseph Greenwall-Cohen, DDS, of the University of Manchester Dental School in the U.K., one of the coauthors. "In general, I would encourage all people to stick to regular toothpaste over charcoal toothpaste." There is little research to date that has tested the safety and effectiveness of charcoal toothpaste against alternatives in head-to-head clinical trials. However, some small studies looking at the effects of charcoal toothpaste have found that it may erode the outer layer of enamel on teeth, increasing the risk of tooth decay. John Brooks, DDS, a researcher at the University of Maryland School of Dentistry in Baltimore who was not involved in the paper, also warned that charcoal may cause cancer. "I have concerns about the chronic exposure of the oral mucosa (tissue) to charcoal as the federal government has classified charcoal as a carcinogen," he said. "Another potential health concern we uncovered was that one-third of the 50 brands of charcoal toothpaste we investigated included bentonite clay, a mineral that may contain crystalline silica, another recognized carcinogen by the federal government." (Click for more...) Women calling for more access to emergency contraception at universities 5/20/2019 1:43:03 PM Women calling for more access to emergency contraception at universities Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 Providing round-the-clock access to morning-after contraception has surfaced as a cause on campuses throughout the country. George Mason University in Virginia and colleges and universities in California and Pennsylvania have installed vending machines that dispense the contraceptive drug called Plan B, or a generic version that can be purchased OTC in stores. Michyah Thomas, a student at Hampton University, has worked on reproductive health at Hampton, as well as in the Hampton Roads community where the school sits. She felt compelled to help increase reproductive health resources for students by launching the hotline with another student, Alexandria Brown, in March. They have given away 26 units of emergency contraception donated by a group in the community. They are among a growing number of college and university students working to increase the availability of emergency contraception on their campuses, said Tarina Keene, executive director of NARAL Pro-Choice Virginia. Keene said many college and university health centers do not carry emergency contraception or have limited hours, restricting access. College students nationally have argued that limited health center hours create a barrier to accessing the emergency contraceptive on campuses during weekends or late at night. (Click for more...) WHO stresses role of GMP in combatting antimicrobial resistance 5/20/2019 1:43:03 PM WHO stresses role of GMP in combatting antimicrobial resistance Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 In an effort to raise awareness on the environmental aspects of interpreting good manufacturing practices (GMP), the World Health Organization (WHO) has issued a 24-page draft document. It addresses managing waste and wastewater from antimicrobials' production, taking into consideration GMP implementation aspects and focusing on critically important antimicrobials. The move is part of WHO's response to the risk of antimicrobial resistance (AMR). WHO is requesting feedback on the draft, including potential ways to combat AMR when manufacturing drugs. WHO warns, "Poor control of waste and wastewater, such as that encountered in some of the countries who are major global producers of APIs and FPPs, can often lead to the entry of antibiotics into waters that are contaminated with pathogenic bacteria from untreated sewage. This increases the risk of the development of antimicrobial resistance." In addition, WHO's Prequalification Team Inspectorate intends to pilot a process to include adequate measures to prevent contamination of environments with antimicrobials. The pilot process is set to launch next year with a focus on critically important antimicrobials manufactured at API and FFP plants. "Approximately 1 year after its launch, the effectiveness of this pilot process will be monitored to decide whether or not it should be modified, strengthened, or expanded," WHO says. (Click for more...) Burosumab vs. conventional therapy in children with X-linked hypophosphatemia 5/20/2019 1:43:01 PM Burosumab vs. conventional therapy in children with X-linked hypophosphatemia Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:43 A Phase III study explored burosumab as a possible intervention for pediatric X-linked hypophosphatemia. Burosumab is a monoclonal antibody that targets fibroblast growth factor 23 (FG23), which presents at high levels in children with the condition, which is also characterized by rickets, bowed legs, and stunted growth. Ultimately, 16 girls and 13 boys were randomly allocated to subcutaneous burosumab, while 18 girls and 14 boys continued to receive conventional therapy consisting of oral phosphate and active vitamin D. Treatment was administered for 64 weeks, with the main endpoint—change in rickets severity—assessed at week 40. Patients in the burosumab group registered significantly greater improvement on their Radiographic Global Impression of Change score, a measure of rickets severity and growth, compared with patients in the conventional therapy group. Treatment-emergent adverse events that may have been associated with treatment were more prevalent with burosumab, affecting 59% of those patients vs. 22% of patients undergoing usual care. (Click for more...) Salmonella alert: Backyard chickens have caused 21-state outbreak, CDC says 5/20/2019 1:42:59 PM Salmonella alert: Backyard chickens have caused 21-state outbreak, CDC says Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:42 CDC reports that backyard poultry, including chicks and ducklings, are behind a 21-state outbreak of salmonella. Fifty-two people have contracted the disease, and five have been hospitalized. More than a quarter of those affected in the outbreak are children younger than age 5 years. "Epidemiologic and laboratory evidence indicate that contact with backyard poultry from multiple hatcheries is the likely source of these outbreaks," CDC says. "People reported obtaining chicks and ducklings from several sources, including agricultural stores, websites and hatcheries." Ohio recorded the most cases in the outbreak thus far, with nine, followed by Missouri with six and Pennsylvania with five. An individual who contracts salmonella will have diarrhea, fever, and abdominal cramps 12-72 hours after infection and then remain sick for 4-7 days, according to CDC. Tips to avoid getting sick from the disease include always washing your hands with soap immediately after touching backyard poultry or the places where they live; prohibiting backyard poultry from coming into your house; designating one pair of shoes to wear when taking care of the birds and then never wearing them inside; not letting children under age 5 years, older adults, and people with compromised immune systems touch the poultry; and only cleaning your backyard poultry equipment outdoors. (Click for more...) A rare genetic mutation leads to cancer. The fix may already be in the pharmacy. 5/20/2019 1:42:59 PM A rare genetic mutation leads to cancer. The fix may already be in the pharmacy. Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:42 In addition to increasing head circumference, a mutation in a gene called Pten markedly raises the risk for several cancers, including prostate and breast cancer, as well as autism and schizophrenia in some individuals. Now, researchers have stumbled on a possible way to counter it. In a study published in the journal Science, researchers found evidence that a compound called indole-3-carbinol (i3c) blocks an enzyme that inhibits the activity of Pten. With the gene more active, patients with the mutation may be better protected against cancer. Researchers note i3c is widely available as a dietary supplement, and experts are debating whether to embark on a clinical trial with it. The new study was done only in mice and in human cancer cells grown in Petri dishes. The findings only apply to Pten gene activity. (Click for more...) Human antibody reveals hidden vulnerability in influenza virus 5/20/2019 1:42:59 PM Human antibody reveals hidden vulnerability in influenza virus Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:42 Researchers have exposed a chink in the armor of the influenza virus protein hemagglutinin (HA), which could have implications for future vaccination practices. According to a report in Cell, the team identified a naturally occurring human antibody, FluA-20, that can "reach into" a part of the HA globular head previously thought to be impenetrable by antibodies. While the window of opportunity is small, FluA-20 that successfully binds to the area—which is where the influenza virus invades and infects cells—can disrupt activity, thereby blocking the spread of virus from cell to cell. Unlike the rest of the HA's head, which is constantly changing, this vulnerable spot tends to be much the same from one strain of virus to the next. Theoretically, then, targeting antibodies to that precise location would effectively combat many different strains of influenza A. Not only might vaccines designed to elicit antibodies against this region potentially offer long-lasting protection against any influenza strain, the investigators speculate, they might even eliminate the need for yearly immunizations. (Click for more...) FDA warns against the use of unauthorized devices for diabetes management 5/20/2019 1:42:55 PM FDA warns against the use of unauthorized devices for diabetes management Sun, 05/19/2019 - 20:00 cbaker_admin Mon, 05/20/2019 - 13:42 FDA on Friday cautioned patients and health care professionals about the risks of using unapproved or unauthorized devices for diabetes management. In a new safety communication, FDA said that using unapproved or unauthorized devices could lead to inaccurate blood glucose measurements or unsafe insulin dosing. "Millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes," said Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health. "Because of the complexity of these devices and the life-saving care they provide, it's important that patients are aware of the risks that arise when they're not used as intended or when they use devices not authorized for sale in the U.S. By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death." FDA noted it is aware of some manufacturers illegally marketing unauthorized devices for diabetes management or illegally marketing components that patients may integrate into unauthorized automated dosing systems. Also, some patients may combine devices or components that are not intended for use with other devices. The agency expressed concern that patients may not be aware of all the risks involved with using components or systems not reviewed by FDA. According to a serious adverse event report received by FDA, a patient's use of an illegally marketed continuous glucose monitoring system along with an unauthorized insulin dosing system led to an insulin overdose that required medical attention. (Click for more...) Medication hoarding common during times of drug shortages 5/20/2019 10:57:45 AM Medication hoarding common during times of drug shortages Mon, 05/20/2019 - 11:00 caldridgeyoung… Mon, 05/20/2019 - 10:57 “In severe cases, the authors noted, “shortages require clinicians to decide which patients receive needed medications and which patients do not,” which can lead to rationing drugs among patients. They suggested that, as a result, systemic approaches are needed to address drug shortages and consequent drug rationing. (Click for more...) Hurting for revenue, Mylan shells out $130M for basket of Aspen drugs 5/20/2019 10:31:49 AM With share prices tumbling and a massive drug-price fixing lawsuit hanging over its head, Mylan’s future is looking increasingly spooky. Could a modest acquisition help turn the tide? (Click for more...) AbbVie's discounting Humira to aid Skyrizi's launch—and a price war could follow: analyst 5/20/2019 10:21:36 AM AbbVie has big plans to grow sales for Humira follow-ups Skyrizi and upadacitinib. Early into its Skyrizi launch for psoriasis, the company has offered discounts on its megablockbuster Humira to secure favorable formulary coverage for its new drug, an analyst writes. (Click for more...) How common is inappropriate use of transmucosal immediate-release fentanyl? 5/20/2019 9:00:13 AM How common is inappropriate use of transmucosal immediate-release fentanyl? Mon, 05/20/2019 - 09:35 caldridgeyoung… Mon, 05/20/2019 - 09:00 In a recent issue of JAMA, Rollman and colleagues evaluated almost 5,000 pages of FDA documents obtained via a Freedom of Information Act to assess whether the REMS program for TIRF products was meeting its goals. (Click for more...) 23.4% Sodium Chloride Injection 5/19/2019 8:00:00 PM Drug: 23.4% Sodium Chloride Injection, Revision Date: Mon, 20 May 2019 (Click for more...) Acetylcysteine Oral and Inhalation Solution 5/19/2019 8:00:00 PM Drug: Acetylcysteine Oral and Inhalation Solution, Revision Date: Mon, 20 May 2019 (Click for more...) Dicyclomine Injection 5/19/2019 8:00:00 PM Drug: Dicyclomine Injection, Revision Date: Mon, 20 May 2019 (Click for more...) Enalaprilat Injection 5/19/2019 8:00:00 PM Drug: Enalaprilat Injection, Revision Date: Mon, 20 May 2019 (Click for more...) Methyldopa Tablets 5/19/2019 8:00:00 PM Drug: Methyldopa Tablets, Revision Date: Mon, 20 May 2019 (Click for more...) Phenytoin Sodium Injection 5/19/2019 8:00:00 PM Drug: Phenytoin Sodium Injection, Revision Date: Mon, 20 May 2019 (Click for more...) Testosterone Enanthate Intramuscular Injection 5/19/2019 8:00:00 PM Drug: Testosterone Enanthate Intramuscular Injection, Revision Date: Mon, 20 May 2019 (Click for more...) Valganciclovir HCl Oral Powder for Solution 5/19/2019 8:00:00 PM Drug: Valganciclovir HCl Oral Powder for Solution, Revision Date: Mon, 20 May 2019 (Click for more...) Atropine Sulfate Injection 5/17/2019 8:00:00 PM Drug: Atropine Sulfate Injection, Revision Date: Sat, 18 May 2019 (Click for more...) Bupivacaine Injection 5/17/2019 8:00:00 PM Drug: Bupivacaine Injection, Revision Date: Sat, 18 May 2019 (Click for more...) Doxorubicin Injection 5/17/2019 8:00:00 PM Drug: Doxorubicin Injection, Revision Date: Sat, 18 May 2019 (Click for more...) Meperidine Hydrochloride Injection 5/17/2019 8:00:00 PM Drug: Meperidine Hydrochloride Injection, Revision Date: Sat, 18 May 2019 (Click for more...) Metoprolol Injection 5/17/2019 8:00:00 PM Drug: Metoprolol Injection, Revision Date: Sat, 18 May 2019 (Click for more...) FDA approves first anticoagulant for children to treat potentially life-threatening blood clots 5/17/2019 5:05:01 PM FDA approves first anticoagulant for children to treat potentially life-threatening blood clots Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 FDA on Thursday approved dalteparin sodium (Fragmin—Pfizer) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in children as young as age 1 month. "Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death," said Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients." The drug, a type of heparin, was first approved by FDA in 1994 for adults. The efficacy of dalteparin sodium in children was based on a trial involving 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. At study completion, 21 children achieved resolution of the qualifying VTE, 7 showed regression, 2 showed no change, 1 experienced recurrence of VTE, and none experienced progression of the VTE. Common adverse effects of patients taking the drug include bleeding, including hemorrhage, thrombocytopenia, hematoma or pain at the injection site, and transient elevation of transaminases. The label for dalteparin sodium includes a boxed warning about the risk of epidural or spinal hematomas that may occur in patients who are anticoagulated due to taking certain low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals are advised to consider these risks when scheduling patients for spinal procedures as patients may be at a higher risk of developing VTE. (Click for more...) Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer 5/17/2019 5:05:01 PM Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Researchers conducting the SOLAR-1 study assessed the effect of alpelisib in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Alpelisib selectively targets PIK3CA, which is implicated in about 40% of cases. Through randomized selection, 572 trial participants were treated with either alpelisib plus fulvestrant or placebo plus fulvestrant. The patients, all of whom had previously undergone endocrine therapy, also were divided into two cohorts based on their tumor-tissue PIK3CA mutation status. The main outcome was progression-free survival at median followup of 20 months. At that time, the primary endpoint for patients with PIK3CA-mutated cancer was 11 months for those who received alpelisib plus fulvestrant—almost double the 5.7 months for controls in the same cohort. The hazard ratio for study enrollees who did not have PIK3CA-mutated cancer was 0.85, and overall response for the cohort was 26.6% with alpelisib–fulvestrant and 12.8% with placebo–fulvestrant. According to the evidence, alpelisib-fulvestrant prolongs progression-free survival in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer who had earlier endocrine therapy. However, the treatment was associated with a greater rate of adverse events compared with placebo. (Click for more...) Dabigatran for prevention of stroke after embolic stroke of undetermined source 5/17/2019 5:05:01 PM Dabigatran for prevention of stroke after embolic stroke of undetermined source Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Although previous research disqualified rivaroxaban as a treatment for cryptogenic stroke, the RE-SPECT ESUS trial investigated dabigatran as another possible option. The multisite study included 5,390 patients who suffered cryptogenic stroke, which is of undetermined origin and presumed to be embolic in nature. According to randomized assignment, 2,695 of the participants received 110 mg or 150 mg of dabigatran twice a day and an equal number received aspirin once per day. Followup took place after a mean 19 months. The main outcome was recurrent stroke, which occurred at a rate of 4.1% per year for the intervention group and 4.8% per year for the control group. Major bleeding, the primary safety endpoint, had an incidence rate of 1.7% per year for dabigatran recipients and 1.4% per year for aspirin-takers. The findings suggest that, like rivaroxaban, dabigatran is not superior to aspirin in preventing repeat stroke in patients with a recent history of embolic stroke of undetermined source. Moreover, although major bleeding was not significantly worse with dabigatran than with aspirin, the drug was associated with more nonmajor but clinically relevant bleeding events. (Click for more...) Start-up is working to help local pharmacies deliver drugs 5/17/2019 5:05:01 PM Start-up is working to help local pharmacies deliver drugs Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Nimble Pharmacy this year shut down its six physical pharmacy locations, which were scattered across the Bay Area, and cut about one-half its staff—40 people—to focus on developing a delivery service that could partner with independent brick-and-mortar pharmacies. The big chain pharmacies such as CVS and Walgreens are getting into delivery, and Amazon is investing heavily in PillPack so that consumers can get all their medicines by mail. That leaves independent pharmacies in a vulnerable position. Founded in 2014, Nimble has raised about $60 million from investors including Sequoia and Khosla Ventures. Nimble turned its attention to the country’s 20,000 independent pharmacies. Since Nimble CEO Talha Sattar started pitching them the idea in January, he has signed up more than 600 pharmacies. Bartell Drugs, a pharmacy chain based in Amazon's hometown of Seattle, updated its website this week to offer a "prescription delivery" service that is "powered by Nimble." Through Nimble, customers "get prescriptions delivered right to your door the same day they’re ready for pick-up," the site says. Bartell says it charges a $6.99 delivery fee plus a 99 cent service fee on top of the standard copay and any taxes. That is comparable to what CVS charges for same-day delivery and a little more than Walgreens' next-day service. (Click for more...) Fred's to close another 104 stores 5/17/2019 5:05:01 PM Fred's to close another 104 stores Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Fred's announced Thursday that it would close more than 100 underperforming stores by the end of June. Liquidation sales would start immediately at the 104 affected locations, the company said. The closures are part of a forbearance agreement and amendment with Fred's creditors that the company reached earlier this week. Fred's must meet other inventory and cash flow target and provide forecasts, among other elements of the forbearance, with the goal of refinancing its debt in late July. This round of closures follows an April announcement that 159 underperforming stores would close by the end of this month. Following the latest round of closures, Fred's store base will be down to 294 locations. "These additional store closures are a difficult, but necessary step in the continued restructuring of Fred's," said company CEO Joseph Anto. (Click for more...) Iowa repository could be a model for drug donation program in Minnesota 5/17/2019 5:05:01 PM Iowa repository could be a model for drug donation program in Minnesota Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 There is a push in Minnesota to launch a drug donation program similar to one in Iowa. A repository located near a suburb of Des Moines, IA, which has been operating for 10 years, collects unused prescription drugs, excluding controlled substances and narcotics. The repository is on track to distribute more than $8 million worth of free medication to patients this year. Medications are collected from community nursing homes and donated to other patients at no cost. Jon-Michael Rosmann, CEO of Iowa-based SafeNetRX, says: "These are all medications that are in sealed, tamper-evident packaging." The repository was established to deal with significant medication waste. Rosmann asserts, "In states where they do not have a drug donation program, we have heard of nursing homes where medications are actually wheeled into a bathroom stall and simply flushed down the toilet." At SafeNetRX, donated medicines are sorted on tables, and a pharmacist will come through and inspect every tablet. The medicine then goes into small bins to be distributed to patients. Pharmacies pay nothing to participate; they can simply go online to place an order that is filled by a pharmacist at the repository. Rosmann says, "Our largest demand for medications is from mental health or behavioral health. There is an incredible demand for these, and they are expensive, so they are often in shortage." (Click for more...) Dedicated teams keep older adults out of hospital 5/17/2019 5:05:01 PM Dedicated teams keep older adults out of hospital Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Research led by Stephanie Chow, MD, from Mount Sinai Hospital in New York City, indicates that health care programs that target the needs of older patients can reduce unnecessary visits to the emergency department. The researchers assessed a model in which two clinicians, a social worker, and a care coordinator provided services for seniors at risk for hospitalization. Under the model, known as the Geriatrics Preventable Admissions Care Team (GERIPACT), the group made house calls "to keep older patients at home," Chow explains. These patients were often diagnosed with stroke, myocardial infarction, or cancer, and were dealing with different doctors and new therapeutic regimens. The intervention typically lasts about 60 days, after which the patient returns to primary care. During regular meetings, the doctor and nurse practitioner ensure that the medical issues are taken care of, and the social worker and care coordinator "make sure that things like health insurance, transportation, meals, housing, and caregivers are in place, and that the caregivers are well supported," Chow says. For individuals who had been hospitalized, a geriatric pharmacist performed medication reconciliation for each patient at discharge. The researchers reviewed the use of health care resources by 78 patients 6 months before and 6 months after the GERIPACT intervention, finding that there were 14 fewer visits to the emergency department after the intervention than before, and 16 fewer hospitalizations. Chow says, "Our hope is that the GERIPACT model will help primary care doctors, many of whom do not do geriatrics." (Click for more...) CMS scales back plan to allow step therapy for Part D protected classes 5/17/2019 5:05:01 PM CMS scales back plan to allow step therapy for Part D protected classes Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 CMS on Thursday finalized a rule that will allow Medicare Part D plan sponsors greater leeway to use prior authorization and step therapy for drugs in protected classes. The final rule is a scaled-back version of a plan to allow Part D plans to use these utilization management tools for members starting new therapies and in all classes save for antiretroviral drugs. CMS postponed a plan that would change its definition of "negotiated price," or the price at the point of sale, to the baseline payment from a Part D plan to a pharmacy. This would have passed price concessions negotiated by pharmacies on to patients. CMS decided to hold off on implementing such a change for the 2020 plan year, though it is still weighing policy changes in this area. Part D plans will also be required to build a tool that can be integrated into provider electronic health records or electronic prescribing to arm them with data on drug pricing. "The improvements we are making to Medicare Advantage and Medicare Part D ... are significant steps toward a Medicare program, a drug pricing marketplace, and a health care system where the patient is at the center and in control," said HHS Secretary Alex Azar. (Click for more...) House passes legislation aiming to shore up health law and lower drug costs 5/17/2019 5:05:01 PM House passes legislation aiming to shore up health law and lower drug costs Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 The House of Representatives on Thursday passed legislation that tied shoring up the Affordable Care Act to lowering drug prices. The vote was 234 to 183, with five Republicans siding with the majority. Democrats had hoped to attract some Republican support, but the minority party called the package "a bailout" for the health law and instead introduced a Republican bill that included only the drug-pricing measures. The passage of the legislation came a week after the House passed another measure pushing back on President Trump’s efforts to weaken the Affordable Care Act. The drug-pricing bills passed Thursday would take aim at the tactics that drug makers use to protect their monopolies and market share. One would seek to ban "pay-for-delay" deals, in which brand-name manufacturers pay makers of generic pharmaceuticals to delay bringing a lower-priced drug to market. Another would loosen the rules on the exclusive 6-month sales period that a generic drug maker gets when it is the first to market after a brand-name drug loses its patent protection. The Senate is working on its own package of health care legislation. The Senate health committee plans to mark up the legislation this summer, focusing less on expansion of coverage and more on the cost of care. (Click for more...) Purdue Pharma hit with fresh round of opioid lawsuits 5/17/2019 5:05:01 PM Purdue Pharma hit with fresh round of opioid lawsuits Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 Attorneys general in six states—Kansas, Iowa, Maryland, Pennsylvania, West Virginia, and Wisconsin—announced this week legal actions against Purdue Pharma about its alleged role in the opioid crisis. The new lawsuits, filed in state courts, broadly claim that the drug maker misled both the public and medical communities about the addictive risks of its prescription analgesics. On Thursday, a Purdue spokesperson denied the new allegations, saying they were "stunningly overbroad legal theories" and adding that the lawsuits "are part of a continuing effort to try these cases in the court of public opinion rather than the justice system." In all, 44 states and 1,700 local municipalities and Native American tribes have brought claims against the manufacturers and distributors of prescription opioids. (Click for more...) Utah will treat medical cannabis just like any other prescription drug 5/17/2019 5:05:01 PM Utah will treat medical cannabis just like any other prescription drug Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 The Utah Department of Occupational and Professional Licensing (DOPL) says it will treat medical marijuana the same as any other controlled substance or prescription medication. Deborah Blackburn, DOPL's Regulatory and Compliance Office, recently told state lawmakers: "We won't pursue disciplinary action against those licensees that receive medical cannabis treatment under the act." This indicates that people with licenses ranging from cosmetology to medicine will not face the threat of losing their job if they are a legal cannabis user. Utah state Rep. Brad Daw, who chairs the legislature's Health & Human Services Interim Committee, believes protections would also likely extend to private employment. Daw says, "It sends a message that it's a medication like any other medication. It has its upsides, it also has abuse potential and we need to be aware of that." After Utah voters approved Proposition 2, which legalized medical marijuana in the state, lawmakers crafted their own bill to create a state-run dispensary network. The legislature ordered state agencies to grow and distribute medical cannabis to qualifying patients. The Utah Department of Agriculture and Food told lawmakers it intends to have marijuana ready for distribution by January 2020. The Utah Department of Health said it would have it ready for distribution from state-run pharmacies by April 2020. There will also be seven privately-licensed pharmacies expected to be operational by March. (Click for more...) Minnesota diabetics make final plea for emergency insulin supply bill 5/17/2019 5:05:01 PM Minnesota diabetics make final plea for emergency insulin supply bill Thu, 05/16/2019 - 20:00 cbaker_admin Fri, 05/17/2019 - 17:05 During a news conference at the state Capitol in St. Paul, a group of diabetics urged Minnesota lawmakers to support a proposal that would give diabetics an emergency supply of insulin if they cannot afford it. The "Alec Smith Emergency Insulin Act" provision is wrapped into the House and Senate health and human services bills, but the versions are slightly different. Under the House bill, anyone could get an emergency supply of insulin for 90 days. Under the Senate bill, patients could receive a 30-day emergency supply, but only those without a high-deductible insurance plan. Abigail Hansmeyer, a type 1 diabetic from New Brighton, MN, said a vial of insulin cost her $20 in 1996; but that same vial now costs her $240, and she needs two to three of them each month. "Our lives have a price tag, and we either pay the price or we die," she said. Several other women at the conference had just returned from purchasing insulin in Canada after discovering it is significantly cheaper there than in the United States. "Our group spent a total of $1,265 on insulin at the Canadian pharmacy," said Lija Greenseid, a St. Paul resident whose teenage daughter has diabetes. "If we had paid retail cost here in the United States, it would have been over $12,000 for the same insulin." The women called on lawmakers to pass the House version of the emergency insulin so patients who have high-deductible plans would not be excluded. They also said the longer emergency supply would give diabetics more time to apply for patient-assistance programs. (Click for more...) Help us collect content for Dr. Art Jacknowitz's HSC Memorial Service 5/17/2019 12:00:00 AM Dear alumni, friends and colleagues, (Click for more...) FDA provides updates on agency's continued commitment to evaluating postmarket safety of Essure 5/16/2019 4:05:01 PM FDA provides updates on agency's continued commitment to evaluating postmarket safety of Essure Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 FDA on Wednesday provided an update on the ongoing postmarketing safety of Essure. Bayer decided to discontinue sales and distribution of the permanent birth control device at the end of 2018. "Even though this device is no longer sold, I want to reiterate the FDA's commitment to regularly communicating with patients and health care professionals about Essure as more information is made available," said Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health. FDA has updated its Essure website to include an analysis of medical device reports received last year, and it updated the Essure 522 study webpage with the number of participants enrolled in the postmarket surveillance study that FDA ordered Bayer to conduct in 2016. FDA said Bayer has enrolled 891 patients in the study as of April 1, with 307 women in the Essure group and 584 in the laparoscopic tubal ligation group. Participants will be followed for 5 years to provide longer-term information on the risks of the device, including issues that may lead women to have the device removed. Bayer must continue enrolling new participants in its study as long as the device is available in the United States. Health care providers may implant Essure up to 1 year from the date it was purchased, so the device will no longer be available after this December. (Click for more...) GOP bill in Wisconsin would allow pharmacists to prescribe birth control 5/16/2019 4:05:01 PM GOP bill in Wisconsin would allow pharmacists to prescribe birth control Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 Wisconsin Reps. Joel Kitchens (R-District 1) and Mary Felzkowski (R-District 35) recently introduced a bill that would allow pharmacists to prescribe the hormonal contraceptive patch and birth control tablets. Patients would be required to fill out a self-assessment questionnaire and undergo a blood pressure screening. Currently, state law only allows doctors to prescribe birth control. In a memo seeking co-sponsors, Kitchens and Felzkowski wrote that they want to give women more choices for reproductive care and reduce unplanned pregnancies. (Click for more...) Maker of oxycodone gets hit with another state lawsuit 5/16/2019 4:05:01 PM Maker of oxycodone gets hit with another state lawsuit Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 The Pennsylvania attorney general's office has filed a lawsuit against Purdue Pharma, making Pennsylvania at least the 39th state to sue the company over allegations that oxycodone hydrochloride (OxyContin) was prescribed inappropriately. The lawsuit says Purdue drug representatives made 531,000 detailing calls on doctors in the state since 2007, when the company settled with Pennsylvania and 25 other states and agreed to stop identifying illegal diversion of its oxycodone hydrochloride and to promote it only for federally approved uses. Only California doctors heard from the company more, according to Pennsylvania. Several physicians are named in the lawsuit whom the state says were call on by the company to promote opioid analgesics despite signs that they were prescribing to addicted patients or alarming pharmacies with their prescribing levels. Attorney General Josh Shapiro did not rule out future legal actions against Purdue sales representatives and executives. (Click for more...) AbbVie, Boehringer settle U.S. patent dispute over drug 5/16/2019 4:05:01 PM AbbVie, Boehringer settle U.S. patent dispute over drug Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 Boehringer Ingelheim and AbbVie say they have resolved a U.S. patent dispute over a biosimilar to the drug adalimumab (Humira—AbbVie). AbbVie says it would grant Boehringer Ingelheim a nonexclusive license to its U.S. adalimumab-based intellectual property, allowing the German company to begin selling its biosimilar adalimumab-adbm (Cyltezo) in the United States starting in July 2023. AbbVie says it would receive royalties from Boehringer Ingelheim. Adalimumab, used to treat diseases ranging from rheumatoid arthritis to gut disorders, had nearly $20 billion in global sales in 2018, accounting for about 61% of AbbVie's total revenue. AbbVie saw a 5.6% decline in adalimumab revenue in the first quarter of 2019 amid competition from biosimilars, leading to a nearly 28% decline in international sales. Sales of adalimumab biosimilars began in Europe late last year after a key AbbVie European patent expired, but a group of U.S. patents built up by AbbVie prevented a U.S. launch. A box of two pre-filled syringes of adalimumab in the United States has a list price of $5,174, which can add up to more than $50,000 or $60,000 a year, depending on the disease being treated. AbbVie sued Boehringer Ingelheim in 2017, alleging that adalimumab-adbm would infringe on many of its patents. At least seven other pharmaceutical companies previously reached licensing deals that will allow them to sell adalimumab biosimilars in the United States starting in 2023. (Click for more...) CVS begins testing of vitamins and supplements 5/16/2019 4:05:01 PM CVS begins testing of vitamins and supplements Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 CVS Pharmacy has started a new program to verify the ingredients of the vitamins and supplements it sells. The community pharmacy's "Tested to Be Trusted" program requires all vitamins and supplements sold in stores or online to undergo third-party testing to confirm that the ingredients listed for those products are correct. The process is also meant to screen products for too-high levels of substances such as heavy metals and pesticides. Company officials report that more than 1,400 products from 152 brands have been tested so far, and that 7% of products failed the test and were either given updated labels or removed. "We are seeing more customers focus on self-care as part of their overall health," said CVS Pharmacy president Kevin Hourican. "CVS is committed to providing access to new products and categories to empower people to practice self-care in their daily lives, especially since self-care varies based on an individual’s needs." The type of products that are being tested include vitamins, probiotics, melatonin, glucosamine, and herbals, such as ginkgo biloba. The move is in line with other efforts by the pharmacy to increase the health of its offerings. (Click for more...) Association of habitual glucosamine use with risk of CVD 5/16/2019 4:05:01 PM Association of habitual glucosamine use with risk of CVD Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 Researchers explored the potentially favorable effect of glucosamine, a non-vitamin and non-mineral supplement widely used for joint pain, on risk of cardiovascular disease (CVD) events in regular users. UK Biobank—a national tool that aspires to improve prevention, diagnosis, and treatment of illnesses—provided patient data for the prospective cohort study. None of the 466,039 participants had CVD at baseline, but investigators assessed for incident CVD events at followup. After a mean 7 years, they documented 10,204 incident CVD events, including 3,060 CVD deaths, 5,745 cases of coronary heart disease, and 3,263 strokes. After adjusting for age, gender, body mass index, race, lifestyle, dietary intakes, drug use, and other supplement use, habitual glucosamine use was shown to lower the risk of total CVD events by 15%. In addition, risk of the independent CVD events studied was reduced by anywhere from 9%–22% in individuals who used glucosamine on a regular basis for relief from osteoarthritis. The results indicate that glucosamine may have a preventive role in the development of CVD; however, the authors agree that more research is necessary. (Click for more...) Chronic use of tramadol after acute pain episode 5/16/2019 4:05:01 PM Chronic use of tramadol after acute pain episode Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 Mayo Clinic researchers questioned how patients taking tramadol for postoperative pain differ, in terms of continued opioid use, from patients taking other short-acting analgesics. They consulted administrative claims data from January 2009 through June 2018 for their observational study, which ultimately included 357,884 opioid-naive patients who received opioids upon discharge after elective surgery. Investigators calculated that taking tramadol by itself increased the risk of additional opioid use—defined as one or more opioid fill 90–180 days after surgery—by 6%, compared with patients taking other short-acting pain medications. The adjusted risk of persistent opioid use—or usage starting in the 180 days after surgery and lasting at least 3 months—was 47% higher with tramadol. Lastly, patients taking only tramadol had a 41% greater risk of prolonged use under the CONSORT definition, which includes any opioid use initiated within 6 months of surgery that lasts 90 days or longer and that includes either 10 opioid fills or a 120-day supply. Based on the similar to slightly higher risk of prolonged opioid use with tramadol compared with other short-acting opioids, the researchers recommend that federal authorities consider reclassifying tramadol and that providers prescribing it for acute pain do so with an abundance of caution. (Click for more...) A rival to onabotulinumtoxinA invites doctors to party in Cancun, with fireworks, confetti and social media posts 5/16/2019 4:05:01 PM A rival to onabotulinumtoxinA invites doctors to party in Cancun, with fireworks, confetti and social media posts Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 With its new wrinkle-smoothing injection, prabotulinumtoxinA-xvfs (Jeuveau), going on sale this week, manufacturer Evolus recently held what it called an advisory board meeting in Cancun with top plastic surgeons and cosmetic dermatologists. A number of doctors talked about the event—which included poolside socializing, free gifts, and an oceanfront dance party—on social media, but failed to disclose that Evolus had paid for their trips. The doctors said the company's marketing would not influence their medical decisions, however, and that the event was a working weekend in which they had been asked to provide expert advice. In an interview, Evolus CEO David Moatazedi said the event was a standard advisory board meeting, similar to those held by competitors. He noted the doctors were not paid or provided with incentives to promote the company, and sometimes the doctors used the hashtags of competing products in their posts as well. He did say Evolus included "social media moments," such as an Evolus-themed runway or a confetti-throwing station. "We wanted to make the break periods of this meeting productive as well for doctors, and many of them like to inform their patients around the newest technologies," Moatazedi said. FDA approved prabotulinumtoxinA-xvfs, Evolus's only product, in February. (Click for more...) Gilead's HIV PrEP to see generic launch in September 2020 5/16/2019 4:05:01 PM Gilead's HIV PrEP to see generic launch in September 2020 Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 In a May 8 Securities and Exchange Commission filing, Gilead Sciences said that a generic version of its emtricitabine/tenofovir antiviral medication (Truvada), which is used for HIV pre-exposure prophylaxis (PrEP), would be available a year earlier than expected. The company noted that due to a settlement it reached with Teva in 2014, it would be introducing a generic in September 2020. A month's supply of the medicine in 2017 cost between $1,600 and $2,000 in the United States, and activist campaigns have focused on making the drug more widely available. In a separate announcement, Gilead Sciences said it will donate to CDC up to 2.4 million bottles of emtricitabine/tenofovir for PrEP to support national efforts to combat HIV. The donation, which extends up to 2030, will transition to emtricitabine/tenofovir alafenamide (Descovy—Gilead Sciences) if the drug is approved for use as PrEP. (Click for more...) CMS issues new guidance addressing spread pricing in Medicaid 5/16/2019 4:05:01 PM CMS issues new guidance addressing spread pricing in Medicaid Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 CMS on Wednesday issued guidance for Medicaid and CHIP managed care plans regarding the calculation of a plan's Medical Loss Ratio (MLR), which represents the percent of premium revenue that goes toward actual claims and activities that improve health care quality, as opposed to administrative costs and profits. CMS regulations require Medicaid and CHIP managed care plans to report an MLR and use an MLR target of 85% in developing rates. The 85% target means that only 15% of the revenue for the managed care plan can be for administrative costs and profits. CMS is concerned that some managed care plans are not accurately reporting PBM spread pricing when they calculate and report MLRs. "The market for prescription drugs is convoluted and opaque," said CMS Administrator Seema Verma. "States are increasingly reporting instances of spread pricing in Medicaid, including cases in Ohio and Texas, and I am concerned that spread pricing is inflating prescription drug costs that are borne by beneficiaries and by taxpayers. Today's guidance will ensure that health plans monitor spread pricing in Medicaid appropriately. PBMs cannot use spread pricing to upcharge health plans and increase costs for states—spread pricing must be monitored and accounted for, and not used to inflate profits." (Click for more...) White House wants patients to know health care prices up front 5/16/2019 4:05:01 PM White House wants patients to know health care prices up front Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 The Trump administration reportedly plans to force greater price disclosure across much of the health care industry, relying on existing administrative tools. The White House is strongly interested in forcing insurers to publicize the negotiated rates they pay for services, according to people familiar with the discussions. The administration also reportedly wants doctors and hospitals to give patients their total price of care before they get services or treatment whether or not the health care provider is in the patient's insurance network. The initiatives are expected to go beyond an earlier proposal to require hospitals, doctors and other medical providers to publicly disclose the secretly negotiated prices they charge insurance companies for services. "We're going to be announcing something, I think over the next 2 weeks, that's going to bring transparency to all of it," President Trump said at a May 9 White House event on surprise billing. "And I think, in a way, it's going to be as important as a health care bill." Among the tools the White House believes it can use to push its agenda on transparency are Labor Department powers under the law that sets minimum standards for private-industry health plans and current hospital-payment rules under Medicare. (Click for more...) Judge orders FDA to speed up review of e-cigarettes 5/16/2019 4:05:01 PM Judge orders FDA to speed up review of e-cigarettes Wed, 05/15/2019 - 20:00 cbaker_admin Thu, 05/16/2019 - 16:05 A federal judge on Wednesday said FDA needs to speed up its reviews of thousands of e-cigarettes on the market. The lawsuit—filed by the American Academy of Pediatrics, Campaign for Tobacco-Free Kids, and other groups in Maryland last year—asserted that the lack of FDA oversight has led to a surge in underage vaping. "It is now the FDA's responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market," the groups said in a statement. U.S. Judge Paul Grimm said FDA's delay was "so extreme as to amount to an abdication of its statutory responsibilities." An FDA spokesperson said the agency is reviewing the court decision and "will continue to tackle the troubling epidemic of e-cigarette use among kids." FDA will also have the option of appealing the decision. While now-former FDA Commissioner Scott Gottlieb moved up the deadline for e-cigarette manufacturers to submit their products for review from 2022 to 2021 just before he stepped down, Wednesday's ruling indicates the agency must move faster. Grimm called for the health groups and FDA to submit plans for moving forward with product reviews within 30 days. (Click for more...) Rediscovering my purpose in Peru 5/16/2019 12:25:11 PM Rediscovering my purpose in Peru Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Thu, 05/16/2019 - 12:25 By Hannah Roppo Our APhA–ASP Chapter at the University of Illinois at Chicago College of Pharmacy is connected with an organization, Casa de Salud Peru, founded by a fellow pharmacist, Kerrylyn Rodriguez...Only allowed members have full access to this content.Log in to view full content. (Click for more...) It starts with one 5/16/2019 12:08:37 PM It starts with one Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Thu, 05/16/2019 - 12:08 By Stanley Dowell We bide by three pillars at The University of Tennessee Health Science Center (UTHSC) College of Pharmacy APhA–ASP Chapter: advocate for the profession of pharmacy through...Only allowed members have full access to this content.Log in to view full content. (Click for more...) The economics of opioids: Fentanyl has a steep price tag in lives, lab costs and resources 5/16/2019 12:00:00 AM Researchers at West Virginia University have studied the overwhelming, detrimental effects of opioid abuse on this state and the nation, and a new wave of the epidemic may be the most daunting yet. (Click for more...) Argatroban Injection 5/15/2019 8:00:00 PM Drug: Argatroban Injection, Revision Date: Thu, 16 May 2019 (Click for more...) Bisacodyl Suppositories 5/15/2019 8:00:00 PM Drug: Bisacodyl Suppositories, Revision Date: Thu, 16 May 2019 (Click for more...) Carisoprodol Tablets 5/15/2019 8:00:00 PM Drug: Carisoprodol Tablets, Revision Date: Thu, 16 May 2019 (Click for more...) Isocarboxazid Tablets 5/15/2019 8:00:00 PM Drug: Isocarboxazid Tablets, Revision Date: Thu, 16 May 2019 (Click for more...) Nelfinavir Mesylate Tablets 5/15/2019 8:00:00 PM Drug: Nelfinavir Mesylate Tablets, Revision Date: Thu, 16 May 2019 (Click for more...) Proparacaine Hydrochloride Ophthalmic Solution 5/15/2019 8:00:00 PM Drug: Proparacaine Hydrochloride Ophthalmic Solution, Revision Date: Thu, 16 May 2019 (Click for more...) Theophylline 12-Hour Extended-Release Tablets 5/15/2019 8:00:00 PM Drug: Theophylline 12-Hour Extended-Release Tablets, Revision Date: Thu, 16 May 2019 (Click for more...) Keep your connection to the pharmacy community 5/15/2019 6:09:55 PM Keep your connection to the pharmacy community Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Wed, 05/15/2019 - 18:09 By Sarah G. Haley, PharmD Hi, “Ami”! As a preceptor and a new practitioner in community pharmacy, I truly resonate with your rotation reflection. I, too, fell in love with the fully accessible provider ...Only allowed members have full access to this content.Log in to view full content. (Click for more...) The final two 5/15/2019 5:58:21 PM The final two Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Wed, 05/15/2019 - 17:58 By “Ami” “36-year-old female, 27 weeks pregnant with multi-drug resistant tuberculosis. Resistant to isoniazid, ethionamide, pyrazinamide and rifampin. What can we administer? Additionally, she is an und...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Considerations for renting versus buying a home 5/15/2019 5:05:47 PM Considerations for renting versus buying a home Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Wed, 05/15/2019 - 17:05 By Timothy Ulbrich, PharmD When I talk with student pharmacists about their financial goals and aspirations, purchasing a home is typically near the top of the list. Purchasing a home is often considere...Only allowed members have full access to this content.Log in to view full content. (Click for more...) FDA warns homeopathic product makers of CGMP violations 5/15/2019 3:05:01 PM FDA warns homeopathic product makers of CGMP violations Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 FDA said Tuesday it has issued warning letters to five companies that product homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations. According to the agency, four of the letters relate to companies that jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their allegedly sterile products were not found to be sterile. The fifth letter details a company's failure to have systems in place to ensure the proper design, monitoring, and control of manufacturing processes. "It's our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately," said FDA Acting Commissioner Ned Sharpless, MD. "When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk." The letters issued to Kadesh Inc., U.S. Continental Marketing, Fill It Pack It, and Bershtel Enterprises, dba as WePackItAll, detail failures to conform to CGMP requirements due to improper methods, facilities, or controls for manufacturing, processing, and packing. The companies jointly manufacture and package Puriton Eye Relief Drops. A warning letter was also issued to Newton Laboratories for human drug CGMP and misbranding violations and unapproved new animal drug violations. (Click for more...) Small pharmacies seeking lawmakers to enforce fair compensation 5/15/2019 3:05:01 PM Small pharmacies seeking lawmakers to enforce fair compensation Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Independent pharmacy owners from across the state of New York gathered at the state capitol in Albany on Tuesday, urging lawmakers to address their concerns regarding PBMs. Many small pharmacy owners like Chris Casey, the owner of Mead Square Pharmacy, said PBMs do not reimburse for prescription drugs fairly. "Buying something for 100 dollars and being reimbursed at 70 dollars that is a loss. Profit is the only way I keep my lights on pay for the labels, I pay for my deliveries. I pay for my customers," said Casey. According to Casey, if lawmakers do not demand fair reimbursement practices he could be forced to close. Small pharmacy owners are hoping lawmakers will move the compensation model to a fee for service. (Click for more...) Kentucky AG sues insulin makers over pricing 5/15/2019 3:05:01 PM Kentucky AG sues insulin makers over pricing Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Three major insulin makers were sued this week by Kentucky's attorney general, who accused them of violating state consumer protection regulations. According to Attorney General Andy Beshear, Eli Lilly, Sanofi, and Novo Nordisk have raised the price of insulin products at least 10 times since 2008. The average cost is now nearly $300, although production costs are still low, often less than $7 per vial. Beshear also noted that the three companies have a 96% market share for insulin products. "It is truly heartbreaking that Kentuckians are suffering, sometimes risking life and limb, because they cannot afford their medications," said Beshear. "The outrageous actions of these drug companies is a big reason we all pay too much for prescription drugs and I am insisting they pay up for putting profits ahead of our Kentucky families." According to the lawsuit, uninsured residents, those with high-deductible health plans, and Medicare Part D recipients have been the hardest hit by the companies' business practices. Kentucky has the seventh-highest diabetes rate in the country, Beshear said. (Click for more...) Justice Department says FDA 'lacks jurisdiction' over death-penalty drugs 5/15/2019 3:05:01 PM Justice Department says FDA 'lacks jurisdiction' over death-penalty drugs Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 The Justice Department has issued a new legal opinion concluding that FDA does not have authority over drugs used in lethal injections. The department's Office of Legal Counsel said that "articles intended for use in capital punishment by a state or the federal government cannot be regulated as 'drugs' or 'devices.'" FDA in 2015 blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision 2 years later. The agency argued the importation was illegal because the drug, sodium thiopental, was not approved in the United States and was improperly labeled. It also cited a 2012 federal injunction preventing the agency from allowing the drug's importation. Texas sued the agency in early 2017, claiming it was interfering with the state's responsibility to carry out its law enforcement duties. The legal opinion from the Justice Department says that drugs intended for executions are different from any others, noting that "they exclusively inflict harm" and "are not intended to produce any benefit for the end user." It expressly highlights "the narrowness of our conclusion," saying that it does not address whether FDA "has jurisdiction over drugs intended for use in physician-assisted suicide." The opinion is unlikely to have any immediate effect, however, because FDA is still operating under the 2012 injunction. It is not clear whether the Justice Department will seek to have that injunction lifted. (Click for more...) Prophylactic antibiotics in the prevention of infection after operative vaginal delivery 5/15/2019 3:05:01 PM Prophylactic antibiotics in the prevention of infection after operative vaginal delivery Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Both Cesarean section and operative vaginal birth are known risk factors for maternal infection, yet antibiotic prophylaxis is widely recommended for only one. Unlike with C-section, there is not enough efficacy data to support a similar guideline for operative vaginal birth. In response, the ANODE researchers recruited thousands of women from various U.K. obstetric units for a randomized trial. The final analysis included results from 1,619 patients who were treated with a single dose of I.V. amoxicillin and clavulanic acid plus 1,606 patients who received placebo following operative vaginal birth. Confirmed or suspected infection within 6 weeks of delivery occurred in 11% of the prophylaxis group and 19% of the controls. Based on the findings, the investigators believe the World Health Organization and other national organizations should amend their guidelines to encourage routine antibiotic prophylaxis in women who undergo operative vaginal birth. (Click for more...) FDA approves first biomarker-driven drug for HCC 5/15/2019 3:05:01 PM FDA approves first biomarker-driven drug for HCC Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 FDA has approved ramucirumab (Cyramza—Eli Lilly) as monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) level greater than or equal to 400 ng/mL and have been treated with sorafenib. Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist and has previously been approved for non-small cell lung cancer, gastric cancer, and colorectal cancer. The new approval is based on results from the REACH-2 trial, a randomized, placebo-controlled Phase III study comparing ramucirumab with placebo in patients with HCC who had been treated with sorafenib and were AFP-high. The median overall survival in the ramucirumab group was 8.5 months vs. 7.3 months for the placebo group. Meanwhile, the median progression-free survival was 2.8 months vs. 1.6 months, respectively. The approval is the first time a biomarker-driven therapy has been approved by FDA for HCC. (Click for more...) Frequency of intracranial hemorrhage with low-dose aspirin in individuals without symptomatic CV disease 5/15/2019 3:05:01 PM Frequency of intracranial hemorrhage with low-dose aspirin in individuals without symptomatic CV disease Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 A systematic review and meta-analysis asked whether taking low-dose aspirin to fend off cardiovascular (CV) disease actually raises the risk of intracranial hemorrhage. A search of the medical literature turned up 13 relevant, randomized clinical trials that compared bleeding outcomes with low-dose aspirin vs. control in patients without symptomatic CV disease. Using a random-effects model to pool results from 134,446 participants in all, the evidence revealed an association between low-dose aspirin and an elevated risk of intracranial bleeding. The relative risks appear to be greatest for subdural or extradural hemorrhage and lower for intracerebral hemorrhage and subarachnoid hemorrhage. The effects were most pronounced in persons of Asian race or ethnicity and those with low body mass index. (Click for more...) Hospital drug-making venture picks antibiotics as first products 5/15/2019 3:05:01 PM Hospital drug-making venture picks antibiotics as first products Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Civica Rx, the nonprofit drugmaking venture established by the hospitals, plans to begin distributing vancomycin hydrochloride and daptomycin before the end of September. The antibiotics are an important staple of hospital efforts to deal with drug-resistant bugs. Hospitals use the antibiotics often to treat bacterial infections that other antibiotics cannot. Vancomycin has been in and out of shortage since 2002, according to the University of Utah Drug Information Service. Daptomycin grew scarce more recently, in 2017. "It's really a good idea to shore up our supply of these products. Without these, the alternatives are pretty grim," says the University of Utah's Erin Fox. Civica Rx and other nontraditional drug suppliers entering the market say they are seeking to fix a system that adds to fast-rising pharmaceutical spending and puts patients at risk. Civica executives say the nonprofit's business model employs contracts that lock in orders for years, aiming to create stability for buyers and manufacturers. Hospital systems do not have to buy every drug Civica brings to market, but must pay for orders they place, even if they do not wind up needing the drugs. Approximately two dozen hospital systems with 900 hospitals have signed on for the chance to buy drugs through Civica, including Intermountain Healthcare, HCA Healthcare, and Providence St. Joseph Health. (Click for more...) U.S. births fall to lowest rates since 1980s 5/15/2019 3:05:01 PM U.S. births fall to lowest rates since 1980s Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Provisional data from CDC's National Center for Health Statistics show that about 3.79 million babies were born in the United States last year, a 2% decline from 2017. The general fertility rate dropped to 59.0, the lowest rate since federal record-keeping began. According to the data, U.S. births have declined in 10 of the last 11 years after peaking in 2007. Experts suggest that reasons for the ongoing declines follow several trends, including teenagers and unmarried women having fewer babies, lower Hispanic fertility rates, and an increase in women obtaining college degrees. Another reason behind the lower rate of births is greater use of long-acting contraceptives. (Click for more...) Titan Pharmaceuticals expands patient access to buprenorphine 5/15/2019 3:05:01 PM Titan Pharmaceuticals expands patient access to buprenorphine Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 San Francisco-based Titan Pharmaceuticals says it has finalized a product purchase and supply agreement with Accredo specialty pharmacy, a subsidiary of Express Scripts. The move expands access to treatment with Titan's buprenorphine implant (Probuphine), a maintenance treatment for opioid use disorder (OUD) in eligible patients. Titan expects the majority of buprenorphine implant sales in the United States to be through the specialty pharmacy distribution model, which seeks to streamline product ordering and fulfillment for health care providers and their staff. Titan's chief commercial officer, Dane Hallberg, said: "Accredo is among the top specialty pharmacy networks in the U.S. with excellent relationships with third-party payors that should enhance the ability of OUD patients to gain access to long-term maintenance treatment with Probuphine." (Click for more...) Youth tobacco use demands stronger FDA response, groups say 5/15/2019 3:05:01 PM Youth tobacco use demands stronger FDA response, groups say Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 More than 30 medical and health organizations, including the American Academy of Family Physicians (AAFP), signed a letter urging FDA to take stronger action to prevent the use of tobacco products by youth. The groups pointed out that one of the most problematic aspects of "Modifications to Compliance Policy for Certain Deemed Tobacco Products," published in the Federal Register in March, is a delay of the regulatory compliance date for e-cigarette manufacturers. The draft guidance's revised date of August 8, 2021 would allow thousands of products to enter or remain in the marketplace for more than 2 years without FDA review. That gap is substantial since FDA has characterized U.S. teen tobacco and e-cigarette use as "epidemic." The letter states that FDA has the authority "to prevent an epidemic of use by youth," but full exercise of that authority was not on display in the draft guidance. Additionally, the draft guidance does not restrict menthol- and mint-flavored e-cigarettes as it does other flavors. FDA argues that mint- and menthol-flavored electronic nicotine delivery systems are important to adults who are seeking to "cease combustible tobacco product use." However, this assertion is not backed by data, the letter notes. Teen use of menthol- and mint-flavored e-cigarettes rose from 42.3% of e-cigarette users in 2017 to 51.2% in 2018, according to CDC data. "Unless there are comprehensive limitations on marketing, youth will continue to be exposed to tobacco marketing," the letter says. (Click for more...) Pfizer calls for compromise on retroactively using suffixes in biologic names 5/15/2019 3:05:01 PM Pfizer calls for compromise on retroactively using suffixes in biologic names Tue, 05/14/2019 - 20:00 cbaker_admin Wed, 05/15/2019 - 15:05 Although FDA once said it would go back and rename certain biologics with nonsense suffixes, it recently proposed leaving them as is. Pfizer has called on the agency to retroactively apply suffixes to biologics that serve as reference products for biosimilars. The compromise would reform the initial proposal and ensure the nonproprietary names of biosimilars, with their four-letter nonsense suffixes, would look similar to the nonproprietary names of their reference products. FDA has said the decision to use the suffixes is part of the agency's focus on pharmacovigilance. Pfizer argues that the suffixes are not being used as intended. Even FDA's biosimilars acting director recently said that she was “not a great fan” of the naming policy. Still, on the other side of the fence, industry group BIO pledged its support for the updated naming convention "to facilitate effective pharmacovigilance practices." (Click for more...) WVU researcher studies incurable blood disease usually diagnosed in children 5/15/2019 12:00:00 AM Treating a stubborn blood disease that strikes children may come down to tweaking energy production in stem cells, suggests research out of West Virginia University. (Click for more...) Buspirone Tablets 5/14/2019 8:00:00 PM Drug: Buspirone Tablets, Revision Date: Wed, 15 May 2019 (Click for more...) Busulfan Injection 5/14/2019 8:00:00 PM Drug: Busulfan Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Calcium Chloride Injection 5/14/2019 8:00:00 PM Drug: Calcium Chloride Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Clonidine Hydrochloride Injection 5/14/2019 8:00:00 PM Drug: Clonidine Hydrochloride Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Ethiodized Oil 5/14/2019 8:00:00 PM Drug: Ethiodized Oil, Revision Date: Wed, 15 May 2019 (Click for more...) Hydroxyprogesterone Caproate Injection 5/14/2019 8:00:00 PM Drug: Hydroxyprogesterone Caproate Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Iopamidol Injection 5/14/2019 8:00:00 PM Drug: Iopamidol Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Mannitol Injection 5/14/2019 8:00:00 PM Drug: Mannitol Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Mepivacaine Injection 5/14/2019 8:00:00 PM Drug: Mepivacaine Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Morphine Injection 5/14/2019 8:00:00 PM Drug: Morphine Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Nystatin Oral Suspension 5/14/2019 8:00:00 PM Drug: Nystatin Oral Suspension, Revision Date: Wed, 15 May 2019 (Click for more...) Prednisone Oral Tablets 5/14/2019 8:00:00 PM Drug: Prednisone Oral Tablets, Revision Date: Wed, 15 May 2019 (Click for more...) Recombinant Zoster Vaccine (Shingrix) 5/14/2019 8:00:00 PM Drug: Recombinant Zoster Vaccine (Shingrix), Revision Date: Wed, 15 May 2019 (Click for more...) RimabotulintoxinB Intramuscular Injection 5/14/2019 8:00:00 PM Drug: RimabotulintoxinB Intramuscular Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Sincalide Injection 5/14/2019 8:00:00 PM Drug: Sincalide Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Sodium Bicarbonate Injection 5/14/2019 8:00:00 PM Drug: Sodium Bicarbonate Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Sodium Polystyrene Sulfonate Powder 5/14/2019 8:00:00 PM Drug: Sodium Polystyrene Sulfonate Powder, Revision Date: Wed, 15 May 2019 (Click for more...) Sterile Water for Injection - Small Volume Vials 5/14/2019 8:00:00 PM Drug: Sterile Water for Injection - Small Volume Vials, Revision Date: Wed, 15 May 2019 (Click for more...) Thiamine Injection 5/14/2019 8:00:00 PM Drug: Thiamine Injection, Revision Date: Wed, 15 May 2019 (Click for more...) Thrombin Topical Powder (Recombinant) 5/14/2019 8:00:00 PM Drug: Thrombin Topical Powder (Recombinant), Revision Date: Wed, 15 May 2019 (Click for more...) I wish I knew: Graduation edition 5/14/2019 5:31:42 PM I wish I knew: Graduation edition Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 17:31 By Bradley Rzendzian, PharmD, MBA A sad, but true, fact of life is that learning the “hard way” is oftentimes the only way. People don’t tell you important details and it makes life a whole lo...Only allowed members have full access to this content.Log in to view full content. (Click for more...) ‘Fearlessly Authentic’ 5/14/2019 5:18:26 PM ‘Fearlessly Authentic’ Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 17:18 ...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Meet your 2019–20 APhA–ASP National Executive Committee 5/14/2019 5:02:17 PM Meet your 2019–20 APhA–ASP National Executive Committee Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 17:02 Kelli Jo Welter, National President Hi all! I am a final-year student pharmacist at Drake University College of Pharmacy & Health Sciences in Des Moines, IA. Signing up for APhA–ASP 5 years ago was ...Only allowed members have full access to this content.Log in to view full content. (Click for more...) APhA Institute experience will benefit my community 5/14/2019 4:43:36 PM APhA Institute experience will benefit my community Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 16:43 By Michelle Bai While at the 2018 APhA Institute on Substance Use Disorders in Salt Lake City, UT, I heard many reasons why people wanted to attend. Some expressed an interest in working within the field...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Understanding the meaning of “Sleepless in Seattle” 5/14/2019 3:34:43 PM Understanding the meaning of “Sleepless in Seattle” Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 15:34 By Jordan Scott I could feel the excitement in the air as everyone awaited the clock to reach 9:30 am. It was a cool, clear Thursday morning in Seattle, a city now filled with the enthusiasm and eager...Only allowed members have full access to this content.Log in to view full content. (Click for more...) The true essence of APhA–ASP 5/14/2019 3:21:33 PM The true essence of APhA–ASP Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 15:21 By Clayton Melson For me, not too long ago, the letters APhA–ASP were nothing more than an abnormal distribution of vowel and consonants in a bowl of alphabet soup. I will admit that in these las...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Developing the pharmacist of the future 5/14/2019 2:55:57 PM Developing the pharmacist of the future Thu, 05/23/2019 - 12:00 jdebruijn@APHA… Tue, 05/14/2019 - 14:55 By Arslan Aslam, Dominika Krynicka, Holly Schaack, and Parker Knueppel The Medical College of Wisconsin (MCW) School of Pharmacy is the only 3-year PharmD program located on an academic medical center in...Only allowed members have full access to this content.Log in to view full content. (Click for more...) 'Spike is concerning': U.S. measles boom heats up with 75 more cases this week 5/14/2019 2:05:01 PM 'Spike is concerning': U.S. measles boom heats up with 75 more cases this week Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 CDC reported Monday that the number of measles cases recorded in the United States increased by 75 last week, for a total of 839 in 23 states. In each of the previous 2 weeks, about 60 additional cases were reported. "This spike is concerning, especially because the downward trend in recent weeks demonstrated that it was possible to keep the infection rates from going up," said Ogbonnaya Omenka, an associate professor and public health specialist at Butler University. According to health officials, most of the new cases were reported in New York City and its suburbs, where hundreds of cases have been reported this year. CDC noted that primary symptoms of the highly infectious disease included fever, runny nose, cough, and a rash that can spread across the entire body. To prevent the disease, the agency is urging vaccination. Worldwide, measles vaccination led to an 80% decline in measles deaths from 2000 to 2017, according to the World Health Organization. (Click for more...) Stem cell treatments flourish with little evidence that they work 5/14/2019 2:05:01 PM Stem cell treatments flourish with little evidence that they work Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 Many people have become captivated by the idea of using stem cells to fix their damaged joints, and some claim to have been helped. However, there is no clear evidence that these treatments work, and their safety has yet to be established. Most researchers, including those at NIH, think that efforts to sell therapies involving adult stem cells, which can develop into different types of cells to replenish tissue, have gotten way ahead of the science. Even so, hundreds of clinics in the United States are trying to meet the demand. Some of these clinics also inject joints with platelet-rich plasma, a solution of platelets extracted from the patient's own blood. A few employers have even agreed to provide insurance coverage for the treatments. There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk. While FDA insists that it does have the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving companies a 3-year grace period in which to describe their products or treatments so the agency can determine whether they meet the criteria of drugs that would require agency approval. So far, few companies have submitted any information. (Click for more...) Frustration mounts as EpiPen shortage hits 1 year 5/14/2019 2:05:01 PM Frustration mounts as EpiPen shortage hits 1 year Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 The ongoing EpiPen shortage has hit the 1-year mark with no end in sight. FDA's website lists the cause as "manufacturing delays." Mylan, which distributes and sells EpiPens, says problems are linked to a subsidiary of Pfizer—Meridian Medical Technologies, which makes the devices. Steve Danehy, director of media relations at Pfizer, says that the company is committed to resolving the shortage as quickly as possible, but he made it clear there is no timetable for it to end. Meridian has also reportedly had a long manufacturing shutdown for maintenance and upgrades in the winter, along with unplanned equipment downtime that made the problem worse and prevented supply reserves from building at the rate of projected demand. Shortages are expected to result in tighter supplies. This could continue through the summer as peak refill season comes as parents prepare for a new school year. "This is a big deal," says Erin Malawer, a parent of a child with food allergies who also has an award-winning blog on the subject. "People are frustrated, calling all over their cities, getting on waiting lists at pharmacies. Families are worried about using their auto-injectors for fear that they might not be able to replace them. That's a dangerous thought." (Click for more...) Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis 5/14/2019 2:05:01 PM Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 Researchers sought to treat multiple sclerosis (MS) by targeting Bruton's tyrosine kinase (BTK), which regulates the functions of B cells and myeloid cells implicated in the disease. Their Phase II study randomized some patients with relapsing MS to evobrutinib, a selective oral BTK inhibitor known to block B-cell activation. Those individuals were assigned to one of three different treatment doses: 25 mg once a day, 75 mg once a day, or 75 mg twice a day. The other trial participants received either dimethyl fumarate (DMF), as a reference, or placebo, for a collective study population of 267. The main outcome was the total number of gadolinium-enhancing lesions detected through MRI at prespecified intervals over a period of 6 months. Although there was no advantage of evobrutinib over placebo at the lower dose or the twice-daily dose, the results indicated that taking 75 mg one per day resulted in significantly fewer enhancing lesions during weeks 12-24 compared with placebo. While promising, the researchers say longer and larger-scale studies are needed. (Click for more...) Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors 5/14/2019 2:05:01 PM Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 FDA has recognized Fournier gangrene (FG) as a new safety concern in patients who take sodium-glucose cotransporter-2 (SGLT2) inhibitors to treat their diabetes. The condition—which causes necrotizing infection of the external genitalia, perineum, and perianal region—is gravely serious and potentially fatal. FDA identified 55 cases in SGLT2 users during the period spanning March 2013 through January 2019. Onset of FG occurred anywhere from 5 days to 49 months after the patients started SGLT2 therapy. Reported complications included diabetic ketoacidosis, sepsis or septic shock, and severe kidney injury. Two patients had to undergo amputation, and three died. Although FDA also identified 19 cases since 1984—including two deaths—of FG in patients taking antigylcemic agents other than SGLT2s, the comparison did not allow investigators to establish causality or incidence. They also were challenged by the variable quality of the case reports, likely underreporting, and confounding by indication. Still, FDA urges physicians who prescribe SGLT2s to be aware of FG and learn to recognize the early warning signs. (Click for more...) Walgreens Boots Alliance's new initiative supports people living with cancer 5/14/2019 2:05:01 PM Walgreens Boots Alliance's new initiative supports people living with cancer Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 Walgreens Boots Alliance (WBA) announced a transatlantic charitable partnership to support people living with cancer. The Collaboration for Cancer Prevention, Research, and Support includes leading European, British, and American cancer groups. The groups committed to pursuing joint projects with the aim of ensuring a future in which patients have access to enhance patient care. "As a global health and well-being enterprise, WBA's purpose is to help people live healthier and happier lives, and we are committed to doing all we can to support the fight against cancer. ... With cancer being a leading cause of death worldwide, WBA is accelerating and facilitating support for research and prevention, as well as assistance for people living with cancer, their loved ones and caregivers," said Ornella Barra, WBA co-chief operating officer and chairman of the company's corporate social responsibility committee. (Click for more...) Opioid doctor and pharmacy 'shoppers' may also shop at home, U-M study suggests 5/14/2019 2:05:01 PM Opioid doctor and pharmacy 'shoppers' may also shop at home, U-M study suggests Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 A new study by University of Michigan researchers indicates that people seeking to "doctor and pharmacy shop" for opioids may be able to find ways to misuse the drugs within their own households. The researchers focused on opioid prescription-filling patterns by 554,000 privately insured people and relatives covered under the same family insurance plan. They defined "shopping" behavior as people who had received opioid prescriptions from four or more prescribers and filled them at four or more pharmacies in the past year. Of the 1.4 million opioid prescriptions for the 554,000 patients in 2016, 0.6%—or 1 out of 167—were filled when a family member met criteria for doctor and pharmacy shopping. This implies that 1.2 million of the 210 million opioid prescriptions in 2016 may have been dispensed to people who have family members with doctor and pharmacy shopping behavior. For opioid prescriptions to children, 0.2% were filled when the child met doctor and pharmacy shopping criteria. Study leader Kao-Ping Chua, a U-M pediatrician and health care researcher, notes, however, that "this apparent doctor and pharmacy shopping behavior in children is likely driven by an adult family member, since children can't obtain opioid prescriptions from multiple prescribers and fill them at multiple pharmacies on their own." When the definition of "doctor and pharmacy shopping" was altered to receiving opioid prescriptions from three or more prescribers and filling them at three or more pharmacies in the past year, the researchers found that 1.9% of opioid prescriptions were filled by patients who had family members meeting the shopping criteria. The findings are published in JAMA Network Open. (Click for more...) OHSU studies effects of allowing pharmacists to prescribe contraception 5/14/2019 2:05:01 PM OHSU studies effects of allowing pharmacists to prescribe contraception Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 In 2015, Oregon became the first state to pass a law allowing pharmacists to prescribe birth control to consumers. A new study from researchers at Oregon Health & Science University (OHSU) reveals that the state's program can increase accessibility to contraception and reduce the overall cost and rate of unintended pregnancies. More than 50 unintended pregnancies were averted during the first 2 years of the program, saving the state approximately $1.6 million in public costs, including costs stemming from medical care associated with poor maternal and infant outcomes. The study, published in Obstetrics and Gynecology, focused on Oregon Medicaid enrollees. OHSU researchers found that 5 months after the law's implementation, pharmacists filled an average of 61 prescriptions per month as the prescriber. In addition, 10% of all new oral and transdermal contraceptive prescription were written by pharmacists, and most claims originated from community chain pharmacies in urban locations. Nearly three-quarters of the women prescribed either the tablet, patch, or ring had not used any form of prescribed birth control the prior month. (Click for more...) U.S. 'emerging adults' with type 1 diabetes face DKA danger 5/14/2019 2:05:01 PM U.S. 'emerging adults' with type 1 diabetes face DKA danger Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 A new study reveals that as teens with type 1 diabetes became young adults in the United States, hospitalization rates for diabetic ketoacidosis increased by 90%, compared with a 23% rise for the same age group in Canada. Lead author Adam Gaffney, MD, a pulmonary and critical care physician at the Cambridge Health Alliance and Harvard Medical School, and colleagues published their findings in the Journal of General Internal Medicine. The authors explain that U.S. youth are at risk for disruptions in health coverage during the transition from adolescence to young adulthood, while Canada's single-payer system offers universal, seamless coverage across a patient's lifespan. Most of the current study's results predate the launch of the Affordable Care Act (ACA), which raised the upper age limit for which private family insurance plans could cover children from 18–26 years. However, Gaffney points out that many families lack private insurance, and some youth who were previously eligible for Medicaid as children may not be as adults. He adds that the ACA did not prevent the "churn" that often accompanies the youth-to-adult care transition, says Gaffney. As clinicians, he says: "We have to be aware of the sorts of financial barriers that our patients are facing, whether in terms of the co-pays they need to pay to see us or the sizable deductibles they may need to cover just to get their insulin." (Click for more...) Maryland governor signs bill banning young adults from buying tobacco, nicotine products 5/14/2019 2:05:01 PM Maryland governor signs bill banning young adults from buying tobacco, nicotine products Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 Gov. Larry Hogan of Maryland on Monday signed into law a bill to raise the age for buying tobacco and nicotine products from 18 to 21 years. The legislation takes effect in October. Maryland will become the ninth state to raise the age for buying cigarettes and other tobacco products. The law will apply to all types of tobacco products, including cigarettes, cigars, smokeless tobacco, e-cigarettes, and vaping devices. Retailers will have to post signs warning that the products can be sold only to those aged 21 years or older. To help the measure pass, the General Assembly accepted an amendment from Sen. Michael Hough, a Frederick County Republican, to include the exception that allows people who are aged 18 years or older to buy tobacco products if they show a military identification. Maryland lobbyist Bruce Bereano, who represents the Maryland Association of Tobacco and Candy Distributors, said the legislation would hurt businesses that border states without the restriction. The bill was supported by the American Cancer Society and by e-cigarette company JUUL Labs. (Click for more...) Interchangeable insulins: FDA holds public meeting 5/14/2019 2:05:01 PM Interchangeable insulins: FDA holds public meeting Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 FDA convened on Monday a public meeting to hear from drug companies and stakeholders about the future of insulin biosimilars. Acting FDA Commissioner Ned Sharpless started the meeting by noting that insulin competition is limited, with only three follow-on insulin products approved since 2015, and that list prices have increased substantially in the past 10 years. The agency issued Friday final guidance on Friday on what studies need to be conducted to establish interchangeability, plus earlier guidance addressed transitioning certain biologics previously regulated as drugs to help companies seeking to bring insulin competitors to market. At the meeting, some industry and academic speakers noted how patients switch between various insulin products, which led to the question of why there should be two distinct categories for insulin biosimilars and interchangeable insulins. Additionally, Mylan's Abhijit Barve highlighted the need for streamlined approaches to developing interchangeable insulins. (Click for more...) Governor vetoes new regulations on PBMs 5/14/2019 2:05:01 PM Governor vetoes new regulations on PBMs Mon, 05/13/2019 - 20:00 cbaker_admin Tue, 05/14/2019 - 14:05 PBMs say they create deals between drug manufacturers, insurance companies, and government health plans over the supply