WVSHP Logo Contact Information
News & Events

News from WVSHP

WVSHP Annual Residency Showcase Updated 10/10/2018: Driving directions, parking Information, and Showcase Residency Programs list now available. SAVE THE DATE WVSHP Annual Residency Showcase Saturday October 20th, 2018 Being Held at the WVU School of Pharmacy Registration coming soon. (Click for more...) 2019 Spring Meeting - Save the date SAVE THE DATE for the Spring Meeting 2019 April 26th and 27th, 2019 Embassy Suites, Charleston, WV (Click for more...) 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...
Congressman aims to break pharma’s insulin ‘pricing monopoly’ by legalizing Canadian imports 2/21/2019 10:18:46 AM Amid a probe into the fast-rising price tags on insulin, Rep. Peter Welch introduced a bill that would make it legal for patients, wholesalers and pharmacists to import low-cost insulin from Canada. (Click for more...) It's not a Brexit problem, Sanofi says of epilepsy drug shortages 2/21/2019 9:34:11 AM Sanofi has restarted production at a plant where manufacturing had to be halted to fix pollution issues. The interruption created spot shortages of seizure drugs Epilim and Depakote in some markets, but Sanofi has assured patients it has nothing to do with the impending divorce of the U.K. and the European Union. (Click for more...) Justice Department, SEC subpoenas put J&J's talc woes under federal microscope 2/21/2019 8:05:14 AM Last month, a prominent U.S. senator asked Johnson & Johnson to turn over documents related to asbestos testing at the center of a set of lawsuits linking its iconic baby powder to cancer. But a new Johnson & Johnson disclosure shows it has bigger problems on its hands. (Click for more...) NHS implements new AI code of conduct 2/21/2019 6:39:50 AM A new code of conduct will ensure that only the best and safest data-driven technologies are used by the NHS, the government says. (Click for more...) Young people in UK ‘suffering from long-term conditions’ despite healthier life choices 2/21/2019 6:20:29 AM Young people in the UK are making healthier life choices for themselves than before, but are more likely to have a poor quality of life, a new study has found. (Click for more...) Cell therapy trial shows 'significant' vision restoration 2/21/2019 6:19:06 AM ReNeuron has found ‘significant restoration of vision’ in patients with retinitis pigmentosa given its human retinal progenitor cells (hRPC) cell therapy. (Click for more...) European Medicines Agency forced to pay London lease 2/21/2019 6:16:18 AM The EMA has lost a high court battle to cancel its £500-million long-term office lease in London. (Click for more...) Abbott and Novo Nordisk strike diabetes digital solution deal 2/21/2019 6:14:58 AM Abbott and Novo Nordisk have entered into a partnership to provide integrated digital solutions to people with diabetes, using insulin. (Click for more...) New cancer drug payment system could speed up treatment 2/21/2019 6:13:45 AM A new report suggests that paying for cancer drugs based on how well they work in practice could help patients get new treatments faster. (Click for more...) FDA thumbs up for Esperoct in haemophilia A 2/21/2019 6:10:08 AM Novo Nordisk has received US approval for haemophilia A drug Esperoct. (Click for more...) Bristol-Myers confirms activist Starboard has its shares. And it wants board seats, too 2/20/2019 8:38:29 PM When it comes to Bristol-Myers Squibb, the rumors are true. Activist investor Starboard Value has indeed taken a stake in the merger-bound pharma—and it’s looking to meddle further. (Click for more...) Amphetamine Mixed Salts, Immediate-Release Tablets 2/20/2019 7:00:00 PM Drug: Amphetamine Mixed Salts, Immediate-Release Tablets, Revision Date: Thu, 21 Feb 2019 (Click for more...) Argatroban Injection 2/20/2019 7:00:00 PM Drug: Argatroban Injection, Revision Date: Thu, 21 Feb 2019 (Click for more...) Prednisolone Acetate 1% Ophthalmic Suspension 2/20/2019 7:00:00 PM Drug: Prednisolone Acetate 1% Ophthalmic Suspension, Revision Date: Thu, 21 Feb 2019 (Click for more...) Darolutamide in nonmetastatic, castration-resistant prostate cancer 2/20/2019 5:05:01 PM Darolutamide in nonmetastatic, castration-resistant prostate cancer Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 The ARAMIS clinical trial investigated the viability of darolutamide in delaying metastatis and mortality in men with nonmetastatic, castration-resistant cancer of the prostate. The Phase III study randomized 955 prostate cancer patients to twice-daily darolutamide, a structurally unique androgen-receptor antagonist, plus routine androgen-deprivation therapy. Another 554 participants received placebo in conjunction with androgen-deprivation therapy. The primary outcome was metastasis-free survival, which was significantly better with darolutamide. Patients taking the study drug resisted metastasis for a median 40.4 months, while controls went a median 18.4 months. The darolutamide group also exhibited improvements in overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event. Meanwhile, adverse events—including seizures, falls, fractures, cognitive disorder, and hypertension—were no worse with darolutamide than with placebo. Quality-of-life outcomes also were comparable between the two groups. (Click for more...) CVS Health reports fourth quarter results and provides 2019 full year guidance 2/20/2019 5:05:01 PM CVS Health reports fourth quarter results and provides 2019 full year guidance Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 CVS Health today announced operating results for the 3 months and year ended December 31, 2018. Revenues increased 12.5% to $54.4 billion in the quarter. For the full year, revenues increased 5.3% to $194.6 billion. For the Pharmacy Services segment, revenues increased 2.2% and 2.7% in the 3 months and year ended December 31, 2018, respectively, compared with the prior year due to increased total pharmacy claims volume, partially offset by continued client pricing pressures. Total pharmacy claims processed increased 5.6% and 6.1%, on a 30-day equivalent basis, in the 3 months and year ended December 31, 2018, respectively. President and CEO Larry Merlo stated, "2018 was a milestone year for CVS Health as we successfully completed our transformational merger with Aetna, began effective implementation of our integration strategy, and took important steps toward building the integrated health care model that will bring substantial value to our various stakeholders. We had strong financial performance and delivered on our operating expectations." The full year 2019 consolidated GAAP operating income is projected to be in the range of $11.7 billion to $12.1 billion while adjusted operating income is projected to be in the range of $14.8 billion to $15.2 billion. CVS Health expects to continue to generate strong cash flows in 2019, with projected cash flow from operations between $9.8 billion and $10.3 billion. (Click for more...) Assessment of the FDA REMS for transmucosal immediate-release fentanyl products 2/20/2019 5:05:01 PM Assessment of the FDA REMS for transmucosal immediate-release fentanyl products Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 A review of FDA documents related to the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) found that surveys of pharmacists, prescribers, and patients showed generally high levels of knowledge about proper TIRF prescribing, but there were also indications of substantial levels of inappropriate TIRF use. In the review of thousands of pages of FDA documents from 2012 to 2017, surveys of nearly 800 individuals a year after the program's inception found that 86.1% of pharmacists, 87.4% of prescribers, and 90.6% of patients correctly said that TIRFs are contraindicated in opioid-nontolerant patients. However, the review also noted that claims-based analyses 5 years after the program's inception found that 34.6%–55.4% of patients who were prescribed TIRF were opioid-nontolerant. Despite the evidence of high rates of off-label TIRF use, the researchers note that few substantive changes were made to the REMS during that time. Additionally, "although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing," the researchers found. (Click for more...) Factors associated with high-quality guidelines for the pharmacologic management of chronic diseases in primary care 2/20/2019 5:05:01 PM Factors associated with high-quality guidelines for the pharmacologic management of chronic diseases in primary care Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 Medical providers often consult clinical practice guidelines (CPGs) to help make care decisions; however, there are no objective measures in place to determine if recommendations are of good quality or not. Researchers in Brazil performed a systematic review focused on the quality of CPGs designed for pharmacologic management of noncommunicable diseases in primary care. After flagging 421 sets of recommendations for inclusion in the study, they used the Appraisal of Guidelines for Research and Evaluation Instrument, version II (AGREE-II) scoring system to assess the quality of those documents. Only 23.5% of them were considered high quality according to AGREE-II, and their strength most often was tied to clarity of presentation along with scope and purpose of the recommendations. Applicability and rigor of development, meanwhile, were areas where CPGs tended to fall short. In addition to rating guidelines' level of quality, AGREE-II helped to identify factors associated with high CPG quality, including development at government institutions, having 20-plus contributing authors, and disclosed funding sources. Year of publication, region of origin, guideline iteration, and scope, meanwhile, were ruled out as having an effect on quality. (Click for more...) Schnucks' Regional Specialty Pharmacy earns URAC accreditation 2/20/2019 5:05:01 PM Schnucks' Regional Specialty Pharmacy earns URAC accreditation Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 The Schnucks Regional Specialty Pharmacy in Maryland Heights, MO, has gained URAC accreditation after successfully fulfilling 94 URAC standards. Noah Tennyson, PharmD, Schnucks' director of specialty pharmacy, says: "URAC accreditation not only demonstrates our commitment to coordinated care for patients with chronic illnesses and complex medical conditions, but it is also considered the specialty pharmacy 'gold standard.' We are proud to have earned this honor and to be one of just a few St. Louis area specialty pharmacies with this designation." Schnucks has eight additional specialty pharmacies that provide medication therapy for patients with complex diseases and says it intends to seek URAC accreditation for each of them. Shawn Griffin, URAC's president and CEO, says: "It's necessary for specialty pharmacies to provide a higher level of treatment for patients so desired outcomes are achieved, and Schnucks Regional Specialty Pharmacy shows a dedication to patient education and safety through the recognition of quality it received with URAC's independent accreditation." (Click for more...) Albertsons pharmacies adopt TemperPack's ClimaCell packaging 2/20/2019 5:05:01 PM Albertsons pharmacies adopt TemperPack's ClimaCell packaging Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 Albertsons Companies and TemperPack are joining forces to divert tens of thousands of pounds of packaging waste from landfills annually. The grocer says it is replacing traditional Styrofoam coolers in its pharmacy shipments with TemperPack's paper-based insulator, ClimaCell. The innovative packaging allows companies to protect temperature-sensitive shipments for up to 80 hours. Albertsons Companies will begin shipping the new packaging to nearly 50,000 specialty care patients, physician offices, and clients starting in late February. A full roll-out is expected over the next year. By using a product that customers can recycle at the curb with the rest of their paper goods, Albertsons Companies anticipates diverting up to 75,000 pounds of packaging from the landfill every year. Rob Hazelton, senior vice president of sales, TemperPack, says: "As one of the most highly respected industry and consumer brands, Albertsons Companies' move to ClimaCell leads the way for other pharmacy and life science companies to switch without sacrificing the efficacy of their temperature-sensitive products." Albertsons Companies' pharmacies switched to ClimaCell as part of their overall goal to make their operations more efficient and reduce the environmental footprint of their business. Erin Shaal, director of Albertsons Companies Specialty Care, says: "We are proud to have a 100% curb-side recyclable product in our packaging portfolio and know it will benefit our customers and our planet." (Click for more...) Report cracks open 'black box' of Kentucky's Medicaid pharmacy system 2/20/2019 5:05:01 PM Report cracks open 'black box' of Kentucky's Medicaid pharmacy system Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 A Kentucky report released Tuesday shows payments to PBMs grew over the past year, even as lawmakers increased scrutiny and passed legislation demanding more transparency about prescription drug costs. PBMs took in $123 million in 2018 through spread pricing, the difference between what the pharmacy benefit company pays the pharmacist and what it bills the state Medicaid program, according to the report. That figure represents a 12.9% increase over the previous year, said the report, which was done by the state Department of Medicaid Services and ordered by the General Assembly. Kentucky Medicaid Commissioner Carol Steckel said in a press release her agency will continue to review the matter. "This report represents the first step in introducing transparency to the pharmacy program," she said in the release Tuesday. "We have additional steps that we will need to take in order to make this program fully transparent." (Click for more...) U.S. Supreme Court denies Maryland bid to revive generic pricing law 2/20/2019 5:05:01 PM U.S. Supreme Court denies Maryland bid to revive generic pricing law Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 The U.S. Supreme Court on Tuesday declined to review a federal appeals court's decision striking down Maryland’s bid to restore a law that state Attorney General Brian Frosh said was needed to protect residents from “monstrous price increases” by generic drug makers. The court’s decision was a setback to new efforts by states to keep down the cost of medicines. The law briefly went into effect, starting in 2017, before the 4th U.S. Circuit Court of Appeals put it on hold with its decision in April 2018. The law was the first of its kind in the nation, although other states have considered similar measures. It applied to generic or off-patent drug makers that manufacture a medicine at least three other firms also make. If those conditions applied, companies could not impose a significant price increase without justifying it to the attorney general, who could ask a judge to order that the price increase not take effect. The appeals court held the measure violated the U.S. Constitution by trying to regulate trade beyond Maryland’s borders. (Click for more...) FDA continues to advance oversight of drug compounding 2/20/2019 5:05:01 PM FDA continues to advance oversight of drug compounding Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 FDA has issued a final rule under section 503A of the Federal Food, Drug, and Cosmetic Act. The rule places six bulk drug substances on the 503A bulks list, which includes substances that compounders can use to compound drugs. Additionally, the rule identifies four bulk drug substances that are not on the list and thus cannot be used for compounding under section 503A. The final rule, which goes into effect on March 21, 2019, sets the criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. The final rule applies to compounding by licensed pharmacists in state-licensed pharmacies or federal facilities, and licensed physicians, FDA said. "Developing the bulks lists for these compounders and outsourcing facilities remains a compounding priority and we look forward to continuing this work in 2019," said FDA Commissioner Scott Gottlieb, MD. (Click for more...) FDA warns against young donor plasma infusions promoted to treat a variety of conditions 2/20/2019 5:05:01 PM FDA warns against young donor plasma infusions promoted to treat a variety of conditions Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 FDA is cautioning consumers about establishments that are offering infusions of plasma from young donors that claim to treat the effects of a number of conditions, ranging from normal aging and memory loss to dementia, multiple sclerosis, and post-traumatic stress disorder. "We have significant public health concerns about the promotion and use of plasma for these purposes," said FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research. "There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product." In an alert issued Tuesday, FDA warned that the treatment using plasma from young donors have not gone through FDA's rigorous safety and efficacy testing. "As a result, the reported uses of these products should not be assumed to be safe or effective," said Gottlieb and Marks. "We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight." (Click for more...) With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling 2/20/2019 5:05:01 PM With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 A national shortage of the bladder cancer drug BCG (Bacillus Calmette-Guérin) is causing some doctors' offices and treatment centers to ration their supplies, leaving some patients without treatment. BCG has been used to fight cancer for decades; however, the drug is not easy to produce and at $100-$200 a dose, it does not bring in tons of cash. Currently, Merck is the only manufacturer of BCG in the U.S. and European markets. "This BCG shortage is a huge deal," said Robert Abouassaly, MD, a urologist at Cleveland Clinic. "We don't have any alternatives that are as effective for these patients." Merck says that it is working at capacity to produce more BCG. The company plans to continue BCG production for "the foreseeable future," says Tyrone Brewer, vice president of global oncology marketing at Merck. "It's not our intent that we'll use this drug to increase our margins," Brewer said. "This is not about the profits, but a mission to save and improve lives." While some chemotherapies can be used instead of BCG, their efficacy is not the same, oncologists say. "There's no question that BCG is more effective," notes Robert Svatek, chief of urologic oncology at University of Texas San Antonio. "Multiple trials have compared BCG to chemo, and every time it wins. It beats the chemo." More extreme options include complete bladder removal surgery or the construction of a bladder-like pouch made out of intestine. (Click for more...) Frequency of sale and reasons for purchase of OTC insulin in the United States 2/20/2019 5:05:01 PM Frequency of sale and reasons for purchase of OTC insulin in the United States Tue, 02/19/2019 - 19:00 cbaker_admin Wed, 02/20/2019 - 17:05 A telephone survey conducted last year queried 561 Walmart and chain pharmacies nationwide about the sale of OTC insulin, which can be purchased without a doctor's order in every state except Indiana. The five-item questionnaire asked about the frequency of OTC insulin sales and possible reasons why consumers may have chosen this option. Based on responses from self-identified pharmacists or pharm techs (99.3%) and pharmacy managers or interns (0.7%), the researchers found that the majority of the locations polled—284 Walmart stores and 216 other chain pharmacies—sell insulin without a prescription. While none of the CVS, Rite Aid, and Walgreens pharmacies surveyed reported selling it every day, 87% of the Walmart locations estimated they sold OTC insulin every day, a median of four vials of its ReliOn brand of insulin daily. Based on Walmart's total 4,700 U.S. pharmacies, the investigators calculated that the retailer sells approximately 18,800 vials each day. Walmart's dominance in OTC insulin sales vs. other chain stores most likely is based on pricing. The ReliOn product runs just under $25 for a 10-mL vial, compared with more than $150 for the branded Eli Lilly and Novo Nordisk OTC offerings sold at other chains. Survey respondents, especially at Walmart, tended to agree that patients sought OTC insulin due to inability to afford the copay for prescription insulin. Considering the popularity of OTC insulin, the researchers say additional study is needed to assess clinical and safety outcomes related to its use. (Click for more...) Allogene Therapeutics to build out facility for allogeneic CAR T treatments 2/20/2019 2:41:48 PM Another CAR T production facility is slated for the U.S. as a biotech moves down the road with a bucket full of cash and a fistful of candidates. But unlike currently approved CAR T treatments, Allogene Therapeutics is looking to use donated T cells that may simplify the very complex manufacturing processes. (Click for more...) Pfizer switches RA patients to lower dose of fast-growing Xeljanz as safety issues arise in postmarketing study 2/20/2019 11:08:10 AM Pfizer moved rheumatoid arthritis patients to a lower Xeljanz dose after a data monitoring board highlighted safety concerns for the 10-mg arm in a postmarketing study. (Click for more...) Pfizer, Merck, J&J well-positioned for M&A and Biogen and BioMarin are prime targets: report 2/20/2019 10:00:04 AM M&A will help the biopharma industry deal with significant new challenges, Morningstar said in a new report, including pressure from lawmakers and payers to lower prices. As companies look for deals to boost their pipelines, oncology, neurology and rare-disease therapeutics will emerge as sought-after assets, the analysts predicted. (Click for more...) Teva, FTC enter expanded settlement barring certain 'pay-for-delay' deals for 10 years 2/20/2019 9:29:58 AM Years after Teva Pharmaceutical Industries entered an FTC settlement on "pay-for-delay" deals, the parties on Tuesday expanded the agreement. (Click for more...) Gov unveils launch of NHSX for digital, data and tech 2/20/2019 8:36:39 AM The government has announced plans to create a new joint organisation for digital, data and technology, to be called NHSX. (Click for more...) Last chance to get your entry in for the 2019 Clinical Researcher of the Year – The Americas competition 2/20/2019 8:33:05 AM This established, challenging, and free-to-enter competition will close for entry on the 25th February – don’t miss out on this great personal development opportunity. (Click for more...) FDA Priority Review for Roche’s entrectinib in cancer treatment 2/20/2019 8:30:55 AM Roche has announced that the FDA has granted Priority Review for entrectinib as a treatment for NTRK fusion-positive, locally advanced or metastatic solid tumours, and to treat metastatic ROS1-positive non-small-cell lung cancer. (Click for more...) Keytruda falls short in late-stage liver cancer trial 2/20/2019 8:27:06 AM MSD's anti-PD-1 therapy Keytruda did not meet its co-primary endpoints in the Phase III KEYNOTE-240 trial involving patients with liver cancer. (Click for more...) First subject dosed in endocrine disorders trial 2/20/2019 8:07:19 AM Sosei has announced that the first subject has been dosed in a UK-based Phase I study of HTL0030310. (Click for more...) Pfizer’s biosimilar Zirabev wins EU approval 2/20/2019 7:55:08 AM Pfizer has announced European approval of its Avastin biosimilar Zirabev. (Click for more...) Intercept's fatty liver drug one step closer to approval 2/20/2019 7:52:22 AM Intercept Pharmaceuticals has announced that its treatment in patients with a progressive fatty liver disease showed an improvement in scarring on the organ. (Click for more...) New sepsis test can diagnose in less than three minutes 2/20/2019 7:39:55 AM New sepsis takes just two and a half minutes to diagnose the disease, meaning it could help save up to 14,000 lives a year. (Click for more...) Merck's Keytruda hits the skids in pivotal trial, putting its liver cancer nod at risk 2/19/2019 10:12:57 PM Merck & Co.’s immunotherapy Keytruda has been hitting its trial targets so often, it’s tempting to think it can't miss. But it can—and Tuesday’s data in liver cancer proves it. The question now is what the FDA will do with that failure. (Click for more...) 0.9% Sodium Chloride Small Volume Bags (< 150 mL) 2/19/2019 7:00:00 PM Drug: 0.9% Sodium Chloride Small Volume Bags (< 150 mL), Revision Date: Wed, 20 Feb 2019 (Click for more...) Amyl Nitrite Inhalation 2/19/2019 7:00:00 PM Drug: Amyl Nitrite Inhalation, Revision Date: Wed, 20 Feb 2019 (Click for more...) Ciprofloxacin Injection 2/19/2019 7:00:00 PM Drug: Ciprofloxacin Injection, Revision Date: Wed, 20 Feb 2019 (Click for more...) Ciprofloxacin Ophthalmic Solution 2/19/2019 7:00:00 PM Drug: Ciprofloxacin Ophthalmic Solution, Revision Date: Wed, 20 Feb 2019 (Click for more...) Cyclosporine Injection 2/19/2019 7:00:00 PM Drug: Cyclosporine Injection, Revision Date: Wed, 20 Feb 2019 (Click for more...) Enoxaparin Sodium Injection 2/19/2019 7:00:00 PM Drug: Enoxaparin Sodium Injection, Revision Date: Wed, 20 Feb 2019 (Click for more...) Fluphenazine Tablets 2/19/2019 7:00:00 PM Drug: Fluphenazine Tablets, Revision Date: Wed, 20 Feb 2019 (Click for more...) Hepatitis A Virus Vaccine Inactivated 2/19/2019 7:00:00 PM Drug: Hepatitis A Virus Vaccine Inactivated, Revision Date: Wed, 20 Feb 2019 (Click for more...) Hepatitis B Vaccine (Recombinant) 2/19/2019 7:00:00 PM Drug: Hepatitis B Vaccine (Recombinant), Revision Date: Wed, 20 Feb 2019 (Click for more...) Washington state House committee passes bill to ban personal, philosophical vaccine exemptions 2/19/2019 4:05:01 PM Washington state House committee passes bill to ban personal, philosophical vaccine exemptions Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 A Washington state House committee on February 15 passed a bill to ban the personal or philosophical exemption for the vaccine against measles, mumps, and rubella (MMR) for school-age children amid an outbreak of the highly infectious virus. The measure passed through the state's Health Care and Wellness Committee, despite opposition from critics who say parents should have a right to choose whether to vaccinate their children. The legislation will now move to the House Rules Committee before it is sent to the full chamber for a vote. A bill proposed in the state Senate would ban personal or philosophical exemptions for all school-required vaccines, not just MMR. Gov. Jay Inslee has declared a state of emergency in Washington following a measles outbreak. There have been 53 confirmed cases of measles as of February 14, according to health officials in Clark County, where a vast majority of this year's measles cases have been located. Of the 53 confirmed cases, 47 people were not immunized against the illness and one had the MMR vaccine. The immunization status of five people has not yet been confirmed. An estimated 6.7% of students in Clark County were exempt from compulsory vaccines upon entering kindergarten by claiming personal or religious reasons in the 2017–18 school year, according to state data. (Click for more...) Epidemiology of invasive group B Streptococcal infections among U.S. adults 2/19/2019 4:05:01 PM Epidemiology of invasive group B Streptococcal infections among U.S. adults Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 The incidence of invasive group B Streptococcus rose among nonpregnant adults in the United States between 2008 and 2016, particularly among those who are obese or who have diabetes, according to new research. "Group B Streptococcus (GBS) is an important cause of invasive bacterial disease," CDC researchers report. "Previous studies have shown a substantial and increasing burden of GBS infections among nonpregnant adults, particularly older adults and those with underlying medical conditions." The population-based surveillance study used the Active Bacterial Core surveillance network to determine the incidence of invasive GBS among nonpregnant adults from 2008 to 2016 and to characterize antimicrobial susceptibility and serotype trends. In all, 21,250 patients with invasive GBS were detected in the network during the study period. In this population, the GBS incidence rose from 8.1 cases per 100,000 population in 2008 to 10.9 cases in 2016. A total of 3,146 cases were reported in 2016. There was a higher GBS incidence among men than women and among African Americans than white, and the incidence increased with age. The researchers estimated there were 27,729 cases of invasive GBS and 1,541 deaths in the United States in 2016. Underlying conditions, most frequently obesity and diabetes, were noted in 95% of the 2016 cases. Additionally, there was an increase in resistance to clindamycin from 37.0% of isolates in 2011 to 43.2% in 2016. "The incidence of invasive GBS in nonpregnant adults continues to rise, with rates now exceeding those for invasive pneumococcal disease," the researchers conclude. (Click for more...) Pembrolizumab plus axitinib vs. sunitinib for advanced renal-cell carcinoma 2/19/2019 4:05:01 PM Pembrolizumab plus axitinib vs. sunitinib for advanced renal-cell carcinoma Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 Building on positive Phase Ib results, which demonstrated antitumor activity against renal-cell carcinoma with pembrolizumab plus axitinib, researchers conducted a Phase III study. The KEYNOTE-426 clinical trial compared outcomes from the combination therapy with outcomes from sunitinib monotherapy. The sample population included 861 patients with treatment-naive advanced clear-cell renal-cell carcinoma. Roughly one-half were randomized to I.V. pembrolizumab once every 3 weeks plus twice-daily oral axitinib. The remaining participants were allocated to daily sunitinib orally for the first 4 weeks of each 6-week cycle. Results from the first interim analysis, after a median followup of 12.8 months, indicate prolonged survival rates and a greater objective response rate with pembrolizumab plus axitinib than with sunitinib alone. Overall survival rates at that point hit 89.9% in patients on the combination therapy and 78.3% in sunitinib patients, while progression-free survival came in at a median 15.1 months and 11.1 months, respectively. The secondary outcome, objective response rate, was 59.3% for pembrolizumab-axitinib compared with 35.7% for sunitinib only. Patients receiving combination therapy were more prone to adverse events, however, with 75.8% suffering grade 3 or higher events of any cause vs. 70.6% in the sunitinib patients. (Click for more...) Avelumab plus axitinib vs. sunitinib for advanced renal-cell carcinoma 2/19/2019 4:05:01 PM Avelumab plus axitinib vs. sunitinib for advanced renal-cell carcinoma Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 Avelumab plus axitinib has shown promising results in patients with advanced renal-cell carcinoma in previous investigations, prompting researchers to undertake Phase III testing. For the study, 442 previously untreated participants were randomly allocated to first-line treatment with I.V. avelumab every 2 weeks plus an oral dose of axitinib twice per day. Another 444 patients were assigned to first-line oral sunitinib, representing usual care, every day for 4 weeks out of a 6-week cycle. The primary co-outcomes were progression-free and overall survival among a subset of 560 patients with programmed death ligand 1-positive tumors. The median was 13.8 months for patients in the avelumab plus axitinib group and 7.2 months for those in the sunitinib group. Overall survival was 11.6 months and 10.7 months, respectively. The objective response rate with the combination therapy in this subset also was more than double that with standard care alone. Avelumab plus axitinib additionally was associated with substantially longer progression-free survival (median 13.8 months) compared with sunitinib (median 8.4 months) in the study population as a whole. Adverse events, meanwhile, were comparable between the two treatment arms. (Click for more...) Measles cases nearly doubled in a year, UN health agency projects 2/19/2019 4:05:01 PM Measles cases nearly doubled in a year, UN health agency projects Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 The World Health Organization (WHO) is warning that measles infections may have doubled globally in the past year as outbreaks continue to plague wealthy and impoverished countries alike. While member states have until this April to report all of 2018's measles cases, the WHO says the 229,068 infections confirmed as of mid-January is already almost twice the 115,117 cases documented at that point in 2017. The final count for that year actually came in much higher: 173,330, with an estimated 110,000 deaths. Measles is highly infectious and potentially deadly but easily prevented, prompting the WHO to press members to step up their vaccination campaigns. To head off outbreaks and eliminate measles, the agency says countries must sustain high immunization coverage with two doses of vaccine, according to Katherine O'Brien, MD, WHO's director of immunization, vaccines, and biologicals. "We're backsliding on the progress that has been made, not because we don't have the tools, but because we're not vaccinating," she believes. To keep outbreaks from occurring, the level of coverage needs to be at 95% or higher; however, uptake has slipped to 85% in recent years. While the WHO emphasizes the importance of targeting communities that are under-immunized, the agency has declined to support vaccine mandates. (Click for more...) Drug company raises price of pain reliever by 70% 2/19/2019 4:05:01 PM Drug company raises price of pain reliever by 70% Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 On February 1, Egalet increased the list price of its pain reliever and anti-inflammatory drug diclofenac (Zorvolex) by 70%. A bottle of 90 capsules now costs $650, compared with $383 a year ago, according to Elsevier's Gold Standard Drug Database. The new list price was made the day after the small pharmaceutical company completed its acquisition of Iroko Pharmaceuticals, the company that had owned diclofenac. Egalet is working to increase the total revenue of its six drugs to at least $80 million annually. (Click for more...) Consultant pharmacists can be one of a long-term care provider's best resources 2/19/2019 4:05:01 PM Consultant pharmacists can be one of a long-term care provider's best resources Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 To help reduce rehospitalizations, which are often linked to adverse drug events and medication errors, many in long-term care view their consultant pharmacist as a critical resource. Experts describe problems that occur when nursing home staff lack a complete picture of patients' medication needs or do not pay attention to expiration or stop dates of drugs in med carts or narcotics in starter kits. An effort on the nurse's part to review the medication list with the consulting pharmacist can help reconcile and eliminate medications and reduce complicated dosing schedules, says Jennifer Hardesty, PharmD, chief clinical officer and corporate compliance officer for Remedi SeniorCare. Others urge caregiving staff to use pharmacists for consultation and to involve them in interdisciplinary meetings. Chad Worz, PharmD, executive director and CEO of the American Society of Consultant Pharmacists, advises nursing home staff to "ask pharmacists to meet with them on a routine basis, invite them to care conferences, and involve them in weekly meetings. Ultimately, any clinician working in this setting needs to be integrated into the care plans of the residents to be most effective." Experts say there has never been a better time to partner with consultant pharmacists on best practices around the use of antibiotics, antipsychotics, and opioids, as well as on diversion issues. Few nursing staff think to exploit pharmacists' expertise in medication management, which is a huge lost opportunity, Worz says, as senior care pharmacists are experts on medication use. "Having them address patients and families is an important step toward lower readmission rates and better outcomes, especially as residents transition home," he says. (Click for more...) Insulin makers must face price-gouging lawsuit, judge rules 2/19/2019 4:05:01 PM Insulin makers must face price-gouging lawsuit, judge rules Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 U.S. District Judge Brian Martinotti in New Jersey has ruled that Eli Lilly, Novo Nordisk, and the U.S. unit of Sanofi must face claims they gouged diabetes patients through deceptive price lists for their life-saving drugs. The judge allowed a proposed class-action lawsuit filed by 67 diabetics against the companies to proceed on consumer-fraud allegations tied to rising insulin prices. Martinotti threw out the plaintiffs' racketeering claims. An increasing number of cases targeting insulin makers’ price hikes have been filed in Martinotti’s court and gathered before the judge for pretrial information exchanges. Plaintiffs contend companies are illegally raising insulin prices to provide rebates for PBMS who decide which drugs get on preferred insurance lists. (Click for more...) Medicare moves closer to CAR-T coverage policy 2/19/2019 4:05:01 PM Medicare moves closer to CAR-T coverage policy Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 CMS has unveiled a proposed national coverage decision (NCD) memo for chimeric antigen receptor T-cell (CAR-T) therapy with several conditions attached, including monitoring of patients enrolled in an approved registry or clinical trial for at least 2 years after treatment. The NCD would be Medicare's first sweeping payment policy for CAR-T. Currently, local Medicare administrative contractors can decide whether to pay for CAR-T therapy. In the proposed decision memo, CMS' medical staff describes CAR-T therapy as "a rapidly evolving field" for which "initial evidence appears promising but inconclusive." CMS is seeking to require that the therapy be provided at certain well-prepared hospitals. Under the proposal, Medicare would require that the CAR-T therapy target a known antigen expressed in the patient's cancer that matches an approved indication for the drug used. CMS intends to use data from registries and studies to help identify the types of patients who benefit from CAR-T therapy. (Click for more...) FDA's new policy to improve access and foster price competition for drugs that face inadequate generic competition 2/19/2019 4:05:01 PM FDA's new policy to improve access and foster price competition for drugs that face inadequate generic competition Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 FDA announced on Friday new guidelines for the use of a novel pathway that offers incentives for the development of generic versions of drugs that have little or no competition. According to FDA Commissioner Scott Gottlieb, MD, "This new pathway for Competitive Generic Therapies (CGTs) is a significant advancement in generic drug competition." He explained that a drug can be designated as a CGT when there is inadequate generic competition—that is, there is no more than one approved drug in the active section of the Orange Book. FDA has already granted more than 100 CGT designation requests, Gottlieb said, and between August and December of 2018, the agency approved the first five abbreviated new drug applications for drugs designated as CGTs. "The successful implementation of these new authorities demonstrates that the competitive generic therapy pathway is efficient and effective at promoting new competition," Gottlieb said. "It's also a key step in making safe and effective generic drugs available to patients quickly while helping to ensure there's adequate competition in the market place, so patients have access to the treatments they need." He noted that FDA is also working to increase the efficiency and predictability of generic drug development. The agency issued on Friday a new draft guidance titled, Competitive Generic Therapies to provide industry with more information about the CGT pathway, including when drug developers can apply for the CGT designation and when they may be eligible for CGT exclusivity. "FDA's implementation of this new pathway is an important part of our broader effort to foster generic competition and help address the high cost of drugs and improve patient access to important medicines," Gottlieb said. (Click for more...) Pharmacists could deny abortion drugs under Senate bill 2/19/2019 4:05:01 PM Pharmacists could deny abortion drugs under Senate bill Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 A bill approved by a Senate committee in Indiana seeks to allow pharmacists to deny women access to abortion-inducing drugs if the pharmacist has moral or ethical objections. Current state law allows physicians or hospital employees to choose not to perform or assist in abortions if they have an ethical or moral objection. The latest bill would expand that to nurses, physician assistants, and pharmacists. (Click for more...) Dozens say they lost eyesight after routine surgery using compounded pharmacy drugs 2/19/2019 4:05:01 PM Dozens say they lost eyesight after routine surgery using compounded pharmacy drugs Mon, 02/18/2019 - 19:00 cbaker_admin Tue, 02/19/2019 - 16:05 Five dozen patients have sued two Dallas-area cataract surgery centers and a compounding pharmacy over their vision loss, which they say was caused by a solution made by Guardian Pharmacy Services in Dallas (not affiliated with the national long-term care Guardian Pharmacy Services). A total of 68 patients say they have lost vision as a result of the compounded drug. In a review, FDA investigators said they found the solution contained formaldehyde and acetone, and they raised questions about the drug's formula and compounding process. Guardian Pharmacy owner Jack Munn asserts that Guardian followed all regulations and has "voluntarily ceased compounding" the drug. In an earlier interview, Jeffrey Whitman, MD, acknowledged: "The medication was not made to specifications and that is what most likely affected the retina." Guardian Pharmacy officials said they only learned about adverse effects 4 months after the solution was first dispensed in November 2016 at Park Central Surgery Center and Key-Whitman Eye Center. (Click for more...) Drug recalls are more widespread than previously thought 2/19/2019 12:12:11 PM Drug recalls are more widespread than previously thought Tue, 02/19/2019 - 12:17 ehaberkorn@aph… Tue, 02/19/2019 - 12:12 From January 2013 to October 2018, approximately 8,000 medications were recalled by pharmaceutical companies across the United States and abroad, the KHN report indicates. Causes ranged from adulteration—the strength of an active ingredient was lower/higher than standards allow, or bacteria/mold or glass/rubber particles were present—to mislabeling and sterility concerns. (Click for more...) Mild flu season so far, with vaccine providing moderate protection, says CDC report 2/19/2019 12:02:19 PM Mild flu season so far, with vaccine providing moderate protection, says CDC report Tue, 02/19/2019 - 12:07 ehaberkorn@aph… Tue, 02/19/2019 - 12:02 Early and interim findings from CDC also point to flu vaccine effectiveness. Flu vaccination this season has reduced the risk of illness from flu by about one-half (47%) for those individuals who were vaccinated. Flu vaccine effectiveness this season for children is estimated as high as 60%. (Click for more...) Former AstraZeneca UK plant back up for sale, putting 270 jobs at risk 2/19/2019 11:36:09 AM A CDMO that has made a habit of snapping up Big Pharma’s discarded manufacturing plants has put a former AstraZeneca plant into bankruptcy. (Click for more...) Under-pressure Allergan backs a CEO-chairman job split—just not right now 2/19/2019 11:08:22 AM Investors have been frustrated with Allergan's reluctance to split up its chairman and CEO roles—particularly activist investor David Tepper. Now, the drugmaker says it supports an investor resolution to split the roles. The catch? It'll hold off until current chief Brent Saunders decides to leave. (Click for more...) Activist Starboard wants to know if Bristol-Myers investors support Celgene buy: report 2/19/2019 10:32:23 AM Activist hedge fund Starboard Value has reportedly hired a proxy solicitor to survey the level of support for the $74 billion Celgene buy. Starboard's interest may be in thwarting the deal by trying to find another buyer for BMS, some analysts have speculated. (Click for more...) Novartis’ AveXis doubles down with $115M manufacturing investment 2/19/2019 10:00:16 AM AveXis, which Novartis acquired last year for $8.7 billion, announced it will invest another $60 million and hire another 200 workers for the site it is building in Durham, North Carolina. That is on top of the $55 million it pledged to invest in the plant last year when it first projected hiring 200 employees. (Click for more...) Insulin pricing lawsuit against Sanofi, Novo Nordisk and Eli Lilly moves forward 2/19/2019 9:50:02 AM Insulin giants are facing unprecedented scrutiny for their pricing, thanks to a growing gap between their retail stickers and prices after behind-the-scenes discounts and rebates. And now they'll have to face class-action claims about those very practices. (Click for more...) Icosapent ethyl reduces ischemic events in patients with hypertriglyceridemia 2/19/2019 7:58:12 AM Primary Category: Focus on Lipids CareKey point: Patients with hypertriglyceridemia on statin therapy who received icosapent ethyl (Vascepa—Amarin) had a significant reduction in adverse cardiovascular (CV) events compared with patients receiving placebo, according to results of the REDUCE-IT trial published in the New England Journal of Medicine. Finer points: Addition of n–3 fatty acid products to statin therapy has failed to show a CV benefit in many studies, but a recent Japanese study showed a significant reduction in major CV events when eicosapentaenoic acid (EPA) was added to statin therapy for patients with elevated lipid levels. The REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) was a Phase IIIb, multicenter, placebo-controlled study that evaluated the effects of icosapent ethyl added to statin therapy for patients with hypertriglyceridemia. Eligible patients (n = 8,179) had a fasting triglyceride level between 150 mg/dL and 499 mg/dL, had an LDL between 40 mg/dL and 100 mg/dL, were on a stable dose of statin therapy for at least 4 weeks, and were at least 45 years of age with established CV disease or at least 50 years of age with diabetes and one additional CV risk factor (mean age 64 y). Patients were randomized to icosapent ethyl 2 g twice daily (n = 4,089) or a placebo containing mineral oil (n = 4,090) and followed for a median of 4.9 years. Most patients had established CV disease (70.7%) and were male (71.2%), white (~90%), and on moderate (~62.5%) or high-dose statin therapy (~31%). At baseline, the median triglyceride level was 216 mg/dL, and the median LDL was 75 mg/dL. The median reduction in triglyceride levels from baseline to 1 year was significantly more with icosapent ethyl than with placebo (–39.0 mg/dL vs. +4.5 mg/dL), and there was a lower increase in LDL levels with active treatment compared with placebo (+2.0 mg/dL vs. +7.0 mg/dL). Results of the primary endpoint, which was a composite of CV death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina, was significantly reduced with icosapent ethyl compared with placebo (hazard ratio 0.75 [95% CI 0.68–0.83], NNT = 21 over 4.9 y). Similar results were observed in favor of icosapent ethyl for the key secondary composite endpoint of CV death, nonfatal MI, or nonfatal stroke (0.74, 0.65–0.83, NNT = 28). The overall rates of adverse events and serious adverse events were similar between groups, but atrial fibrillation (5.3% vs. 3.9%) and peripheral edema (6.5% vs. 5.0%) were more common in the icosapent ethyl group. Serious bleeding events also occurred at a slightly higher rate in the icosapent ethyl group (2.7% vs. 2.1%). What you need to know: The authors noted that results of the REDUCE-IT trial are different from previous studies, with significant benefits observed with use of icosapent ethyl in patients with elevated triglyceride levels on statin therapy. This is one of the first non-LDL-targeted trials to show a CV benefit and may be featured in future guidelines. The authors further commented that the benefits observed in this trial might be attributable to use of a highly purified and stable EPA ethyl ester (with other trials using a low ratio of EPA to docosahexaenoic acid [DHA]) or to the higher daily dose of icosapent ethyl given. They concluded that additional studies are needed to confirm the current results. They stressed that the REDUCE-IT outcomes should not be generalized to other n–3 fatty acid mixtures, which are variable and unregulated and have not demonstrated clinical benefit. An accompanying editorial noted that use of mineral oil as the placebo arm comparator could have raised levels of atherogenic lipoproteins and complicated the assessment of adverse events (e.g., GI events). What your patients need to know: Inform patients that results of a new study suggest that use of icosapent ethyl, an n–3 fatty acid, may reduce the risk of adverse CV events when given to those with elevated triglyceride levels already on statins. Encourage them to talk to their prescriber to determine if this may be a treatment option to help reduce CV risks. Sources: Bhatt DL et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11–22. Kastelein JJP, et al. Fishing for the miracle of eicosapentaenoic acid. N Engl J Med. 2019;380(1):89–90. Primary Section Advisor: Amber L. BriggsSecondary Category: Cardiology (Click for more...) Glucosamine may be an option for knee osteoarthritis 2/19/2019 7:49:54 AM Primary Category: RheumatologyKey point: Decreases in pain for patients with knee osteoarthritis were observed for celecoxib and glucosamine sulfate, but the effect only remained significant for glucosamine sulfate once the data were further analyzed, according to results of a systematic review and network meta-analysis published in JAMA. Finer points: Data on long-term pain control in patients with knee osteoarthritis is lacking, with many studies focusing only on short-term pain relief. Gregori and colleagues conducted a systematic review and network meta-analysis of 33 pharmacologic interventions for patients with knee osteoarthritis across 47 comparative studies that lasted at least 12 months (range 1–4 y). The studies included 22,037 patients, with most being women (70%) and having a mean age range of 55 to 70 years. Of the 33 interventions, 31 were evaluated for pain, 13 for physical function, and 16 for joint structure. The classes of therapies included in the analysis were analgesics, antioxidants, bone-acting agents, NSAIDs, intra-articular injections, osteoporosis agents, and disease-modifying agents. The analysis showed that there was a large amount of uncertainty around all the estimates and no improvement in pain was noted for 29 of the 31 interventions studied. The only treatments associated with decreased pain were the NSAID celecoxib (standardized mean difference [SMD] -0.18, 95% CI -0.35 to -0.01) and for glucosamine sulfate (-0.29, -0.49 to -0.09). When the data were reanalyzed to include a mean difference on a normalized scale from 0 to 100 and to exclude trials with a high risk of bias, a significant reduction in pain was only observed for glucosamine sulfate. Improvements in physical function and joint structure were also found with glucosamine sulfate. What you need to know: The current analysis adds additional data suggesting glucosamine sulfate may offer pain reduction in some patients with knee osteoarthritis. However, as noted by the authors, the analysis has several limitations, such as the considerable uncertainty about all the estimates, the small size of the majority of trials included in the review, relatively few direct comparisons, and the lack of consideration for nonpharmacologic interventions used in studies. Patients with chronic osteoarthritis have limited options, so effective treatments are always needed. Although nonpharmacologic approaches such as exercise and physical therapy are mainstays, many patients continue to have pain despite these interventions. Acetaminophen has traditionally been the first-line agent used for pain control because it lacks the safety concerns associated with NSAIDs, but NSAIDs are also frequently used. Data on use of glucosamine for management of knee osteoarthritis has been conflicting, with some data supporting its efficacy and others concluding it is not useful. The current review suggests that glucosamine sulfate may be worth a try for long-term use. Patients need to understand that this therapy may take time to work (weeks to months), so they should not expect immediate pain relief, as occurs with available analgesics. What your patients need to know: Inform patients with knee osteoarthritis that results of a large data review suggest that glucosamine sulfate may be an option to help reduce pain. Inform them that this agent is available OTC, and educate them on potential adverse reactions. Also, encourage them to discuss use of glucosamine sulfate with their provider to ensure it fits with their current treatment plan. Sources: Gregori D, et al. Association of pharmacological treatments with long-term pain control in patients with knee osteoarthritis: a systematic review and meta-analysis. JAMA. 2018;320(24):2564–79. Primary Section Advisor: Arthur A. SchunaSecondary Category: Alternative Medicines Corner (Click for more...) 25% Dextrose Injection 2/18/2019 7:00:00 PM Drug: 25% Dextrose Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Benztropine Mesylate Injection 2/18/2019 7:00:00 PM Drug: Benztropine Mesylate Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Bumetanide Injection 2/18/2019 7:00:00 PM Drug: Bumetanide Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Bupivacaine Injection 2/18/2019 7:00:00 PM Drug: Bupivacaine Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Bupivacaine with Epinephrine Injection 2/18/2019 7:00:00 PM Drug: Bupivacaine with Epinephrine Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Cefepime Injection 2/18/2019 7:00:00 PM Drug: Cefepime Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Deferoxamine Injection 2/18/2019 7:00:00 PM Drug: Deferoxamine Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Ketamine Injection 2/18/2019 7:00:00 PM Drug: Ketamine Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Meperidine Hydrochloride Injection 2/18/2019 7:00:00 PM Drug: Meperidine Hydrochloride Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Ropivacaine Injection 2/18/2019 7:00:00 PM Drug: Ropivacaine Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Sodium Bicarbonate Injection 2/18/2019 7:00:00 PM Drug: Sodium Bicarbonate Injection, Revision Date: Tue, 19 Feb 2019 (Click for more...) Dr. Reddy’s oncology drug plant escapes cloud of FDA warning letter 2/18/2019 11:13:44 AM Just days after bad news about manufacturing wreaked havoc with Dr. Reddy’s shares, India's second-largest drugmaker was able to report something positive. (Click for more...) Doctors’ advice for pharma in 2019? Lay off DTC and ramp up generics: study 2/18/2019 8:39:00 AM Doctors think pharma should go on a DTC diet. When asked what pharma companies can do in 2019 to reduce drug prices, more than half (52%) said pharma should spend less money on DTC advertising and marketing. (Click for more...) WVU School of Pharmacy renames its Office of Student Services 2/18/2019 12:00:00 AM The West Virginia University School of Pharmacy is making it easier for students and parents to navigate the admissions process. (Click for more...) 23.4% Sodium Chloride Injection 2/17/2019 7:00:00 PM Drug: 23.4% Sodium Chloride Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) 50% Dextrose Injection 2/17/2019 7:00:00 PM Drug: 50% Dextrose Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Cefuroxime Sodium Injection 2/17/2019 7:00:00 PM Drug: Cefuroxime Sodium Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Dicyclomine Injection 2/17/2019 7:00:00 PM Drug: Dicyclomine Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Fluorouracil Injection 2/17/2019 7:00:00 PM Drug: Fluorouracil Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Furosemide Injection 2/17/2019 7:00:00 PM Drug: Furosemide Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Leucovorin Calcium Injection 2/17/2019 7:00:00 PM Drug: Leucovorin Calcium Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Levothyroxine Sodium Injection 2/17/2019 7:00:00 PM Drug: Levothyroxine Sodium Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Lidocaine with Epinephrine Injection 2/17/2019 7:00:00 PM Drug: Lidocaine with Epinephrine Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Mepivacaine Injection 2/17/2019 7:00:00 PM Drug: Mepivacaine Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Mitoxantrone Hydrochloride Injection 2/17/2019 7:00:00 PM Drug: Mitoxantrone Hydrochloride Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Potassium Phosphate Injection 2/17/2019 7:00:00 PM Drug: Potassium Phosphate Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Secobarbital Capsules 2/17/2019 7:00:00 PM Drug: Secobarbital Capsules, Revision Date: Mon, 18 Feb 2019 (Click for more...) Sodium Phosphate Injection 2/17/2019 7:00:00 PM Drug: Sodium Phosphate Injection, Revision Date: Mon, 18 Feb 2019 (Click for more...) Between Merck and Pfizer, the race is on in kidney cancer—but analysts are calling it early 2/17/2019 4:58:51 PM The race is on between two Big Pharmas to snag a new indication in kidney cancer, but thanks to new data from Merck & Co., it may not matter who gets there first. (Click for more...) Not ready to quit smoking cold turkey? Pfizer offers 'slow turkey' campaign for Chantix 2/17/2019 2:29:17 PM Pfizer is introducing a new way to quit smoking. "Slow turkey" is the strategic—and literal—idea in its latest TV commercial for smoking cessation drug Chantix. (Click for more...) Influenza vaccines this winter providing moderate levels of protection, CDC data show 2/15/2019 12:05:01 PM Influenza vaccines this winter providing moderate levels of protection, CDC data show Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 Interim estimates from CDC suggest that this year's influenza vaccine is providing about 47% protection against all influenza infections. The protection rate against H1N1 viruses—which are causing most of this year's illnesses around the United States—is 46%, while the protection rate against H3N2 viruses—which are the main viruses in the southeastern part of the country—is 44%. The signs of effectiveness so far this influenza season are "encouraging," according to Alicia Fry, MD, head of epidemiology and prevention in CDC's Influenza Branch. She noted the level of protection provided by the influenza vaccine is within the range of what one would expect during a season in which H1N1 viruses predominate, and it is an improvement over last year, when the mid-season estimate indicated that about 75% of people who had obtained an influenza vaccine were not protected against H3N2 viruses, which were dominant last year. For children aged 17 years and younger, protection against H1N1 was about 62%. For older adults, however, the effectiveness was only about 24% overall and 8% against H1N1 viruses in individuals aged 50 years and older. Fry noted, however, that researchers saw so few infections among older adults that it is too early to determine how well the vaccine was working among these individuals. "We had so few [cases] in the 65 and older [age group] that we couldn't even come up with an estimate," Fry said. New CDC data also indicate that an estimated 9,600–15,900 people died from influenza-associated causes between October 1 and February 2. Up to 15 million people may have been infected and more than 7 million may have sought medical care for influenza, CDC estimates. (Click for more...) FDA authorizes first interoperable insulin pump 2/15/2019 12:05:01 PM FDA authorizes first interoperable insulin pump Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 FDA announced Thursday that it has permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (Tandem Diabetes Care Inc.) for delivering insulin under the skin for children and adults with diabetes. The insulin pump, known as an alternate controller enabled (ACE) infusion pump, is the first interoperable pump. This means it can be used with different components that make up diabetes therapy systems. "We've heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible," said FDA Commissioner Scott Gottlieb, MD. "The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently." FDA said it is also establishing criteria, called special controls, that outline the requirements for ensuring the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. (Click for more...) Two decades of data reveal overall increase in pain, opioid use among U.S. adults 2/15/2019 12:05:01 PM Two decades of data reveal overall increase in pain, opioid use among U.S. adults Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 New research finds that significantly more Americans are coping with at least one painful noncancer health condition and that they increasingly are turning to opioids to manage the pain. The conclusions are based on data from the Medical Expenditure Panel Survey, which provided a nationally representative sample. As of 2013–14, the data show, painful disorders affected 178 million adults in this country, up from 120.2 million in 1997–98. Roughly one-third of those individuals reported moderate or severe pain-related interference with normal work duties. They were more likely than those with minimal pain-related interference to use morphine, fentanyl, or other potent opioids. In fact, their consumption of these analgesics more than doubled over the study period. Severe pain-related interference was also associated with the likelihood of having four or more opioid prescriptions and of having seen a doctor for pain six or more times. The study appears in the Journal of Pain. "This long-term picture of pain management ... offers insights that can help improve decision-making by stakeholders—from patients and providers to payers and policymakers," says Helene Langevin, MD, director of NIH's National Center for Complementary and Integrative Health, which spearheaded the study. (Click for more...) How the quest for lower drug prices is hurting children with asthma 2/15/2019 12:05:01 PM How the quest for lower drug prices is hurting children with asthma Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 Insurers, both private and public, use non-medical formulary switching to limit the coverage of prescription drugs to the medications for which they can negotiate a lower price. What that means for patients is that at any given time, their insurance provider may stop covering the medication they take and ask them to take a similar one instead. "There are instances when difficult decisions have to be made due to formularies, but in general, [medication switching] is not this thing that is done on purpose just to save a couple of bucks here and there," says Daniel Nam, executive director of federal programs at America's Health Insurance Plans, the largest advocacy organization for health insurance providers nationwide. In the case of children with asthma who require daily medication to bring down the inflammation in their lungs, medication switching can lead to delays in treatment that put them at risk for an asthma flare, which could in turn land them in the emergency room, says Tyra Bryant-Stephens, MD, professor of pediatrics at The Children's Hospital of Philadelphia and director of the Community Asthma Prevention Program. (Click for more...) HIMSS19: CVS, Cigna execs tout pharmacies amid pricing debate 2/15/2019 12:05:01 PM HIMSS19: CVS, Cigna execs tout pharmacies amid pricing debate Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 PBM executives appearing at the HIMSS19 conference on Wednesday touted their ability to cut costs for patients amid a wider debate about their role in the drug supply chain. The executives emphasized that they are well-placed to help drive down costs, given patients interact far more often with pharmacists than other health care providers. "Pharmacy is the gateway for most patients. Most patients will go to a hospital less than once a year. They'll go to a doctor less than twice a year. But the average person uses a pharmacy 12 times a year," said Steve Miller, chief operating officer at Cigna. "We're trying to take advantage of [community pharmacy] as an opportunity to be able to reach patients on a face-to-face basis," said Troy Brennan, the executive vice president and chief medical officer of CVS Health. Brennan cited the company's new HUB stores in Houston, noting CVS Health has identified 30-40% of its customers who come in to get tested have high blood pressure, and that 80% of them had been previously undiagnosed. Many solutions will come from "basic blocking and tackling" such as this, Brennan thinks—from measures "we consider to be relatively below the level of primary care in this country." The executives spoke favorably of proposed rules released earlier this week to push the industry to prioritize interoperability, with Miller noting it's imperative to give data back to the patient. (Click for more...) Electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care 2/15/2019 12:05:01 PM Electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 The REDUCE study examined whether electronically delivered feedback and decision support interventions safely and effectively lower antibiotic prescribing for self-limiting respiratory tract infections. As part of the trial, 41 U.K. general practices were randomly assigned to antimicrobial stewardship (AMS). The protocol entailed automated monthly feedback reports of antibiotic prescribing and electronic decision support resources to guide appropriate prescribing over the course of 1 year. The other 38 practices involved in the study were allocated to standard care. The main endpoint was the rate of antibiotic prescriptions for respiratory tract infections, based on electronic health records. According to the data, AMS was associated with a moderate reduction in antibiotic prescribing, with a prescribing rate of 98.7 per 1,000 patient–years vs. 107.6 per 1,000 patient–years for usual care. The effect was most prevalent in individuals aged 15–84 years, with one antibiotic prescription per year avoided for every 62 patients. No benefit was apparent in children younger than age 15 years or adults aged 85 years and older, underscoring the need for more study in these populations. Electronically delivered prescribing interventions also appeared to be safe, with no evidence of an increase in serious bacterial complications. (Click for more...) Automaker retirees racked up a $2 billion pharmacy bill in 2018 2/15/2019 12:05:01 PM Automaker retirees racked up a $2 billion pharmacy bill in 2018 Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 A retiree health-care trust set up by Detroit automakers and the United Auto Workers union spent $4.2 billion on pharmaceutical-related expenses. Nearly one-half of that sum went to prescription drugs, Alan Reuther, legislative consultant for the UAW Retiree Medical Benefits Trust, told the House Ways and Means Committee, which held a hearing Tuesday on rising costs. The expenditures covered 656,000 retired union members and their dependents. Approximately 80% of the trust's members are covered by Medicare, and the trust provides supplemental coverage for prescription drugs, plus other health costs. The largest drug outlay for the trust in recent years has been insulin. About 50,000 trust members use the drug, and spending on it increased 51% from 2013 to 2017. Last year, the trust’s insulin costs were $235.5 million, Reuther said, or about $4,700 per patient. (Click for more...) Mass. commission looks to ease prescription drug spending 2/15/2019 12:05:01 PM Mass. commission looks to ease prescription drug spending Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 The Massachusetts Health Policy Commission (HPC) is urging insurers, policymakers, and medical professionals to take action on prescription drug spending and administrative expenses. On February 13, the commission approved a number of policy recommendations intended to curb the growth in health care costs. HPC executive director David Seltz noted that existing laws allow health care providers and insurers to be evaluated based on their contributions to total spending growth while excluding drug companies. The report recommended authorizing the Executive Office of Health and Human Services to establish a process allowing "rigorous review" of high-cost drugs and increasing MassHealth's ability to negotiate directly with manufacturers for additional supplemental rebates. Seltz said issues of "administrative complexity" will be a top priority for the commission this year. He added that the commission has heard "increasing frustration" from health plans and providers over the number of processes to deliver and bill for care. The report urged the health care industry and state government to identify and address administrative complexity that drives up costs without adding value, in such areas as "payment arrangements, insurance billing and coding, risk adjustment, quality measurement reporting, provider credentialing, and use of electronic health records." (Click for more...) Vaccine storage in Ventura County failed to meet standards 2/15/2019 12:05:01 PM Vaccine storage in Ventura County failed to meet standards Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 In October 2017, Ventura County (CA) health officials, concerned that vaccines were getting too warm while being transported to clinics, changed their protocol. But a routine audit in November found that the ice packs they were using may have frozen some of the medicines and lowered their effectiveness. The agency then offered to reimmunize everyone who had received a vaccine that was delivered in faulty packaging. "There is no way to tell whether or not they were ineffective," says Jason Arimura, director of pharmacy services for Ventura County Medical Center. Out of an abundance of caution, "we just notified everyone." Approximately 23,000 patients were affected. Most hospitals, clinics, and doctors are vigilant in properly storing their vaccines, according to experts, and research suggests that compromised vaccines given to patients are not harmful. L.J Tan, chief strategy officer for the nonprofit vaccination advocacy group Immunization Action Coalition, says the nation's vaccine stock is likely one of "the safest in the world." (Click for more...) Arkansas bill would require e-prescription for opioids 2/15/2019 12:05:01 PM Arkansas bill would require e-prescription for opioids Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 A bill now moving through the Arkansas Legislature calls for prescriptions for controlled substances such as opioids to be moved to a paperless, e-prescription system by 2021. Senate Bill 174, proposed by state Rep. Kim Hammer (R-Benton), was recommended by the Senate Judiciary Committee on a voice vote on February 13. Arkansas Drug Director Kirk Lane told lawmakers that between 3% and 9% of opioid prescriptions in the state are forgeries. He added that e-prescriptions are harder to tamper with, and the technology to receive online scripts is available to 98% of pharmacists in Arkansas. Scott Pace with the National Association of Chain Drug Stores expressed support for the bill, saying that 14 other states have already migrated to an e-prescription network without serious issues. An amendment to the bill approved by the committee allows for HHS to grant a waiver from the law in case of economic hardship, technological limitations, or other "exceptional circumstances." Several committee members expressed concern about using an electronic system in rural areas and in the event of a natural disaster. (Click for more...) Child's diabetes scare leads to Oregon bill allowing emergency refills of insulin 2/15/2019 12:05:01 PM Child's diabetes scare leads to Oregon bill allowing emergency refills of insulin Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 Oregon's Senate Bill 9, which would allow pharmacists to prescribe and dispense refills of insulin and diabetes supplies in emergency situations, received its first hearing on February 13. The bill originated after a legislative staffer reported that the insulin pump used by her daughter—who has type 1 diabetes—failed on a Thursday, meaning she would not be able to get in contact with her doctor for a new prescription until Monday. To avoid a trip to the emergency room, the staffer was forced to borrow insulin from another employee in the building whose child also has type 1 diabetes. Since that time, a law and Board of Pharmacy rules were passed to permit pharmacies to dispense insulin on an emergency basis. However, Senate President Peter Courtney and his staff found out this was not happening because the necessary guidelines were not in place. Courtney's legislation expands on "Kevin's Law," a law in place in 15 states across the country named after a 36-year-old who was unable to get insulin during the holidays in 2013 and died soon after. The bill would require the emergency insulin dispensed by a pharmacist to be a 30-day amount or less. Additionally, a person could receive no more than three emergency refills per year and pharmacists would be required to go through a training program. (Click for more...) Letter urges congressional action to stimulate antibiotic development 2/15/2019 12:05:01 PM Letter urges congressional action to stimulate antibiotic development Thu, 02/14/2019 - 19:00 cbaker_admin Fri, 02/15/2019 - 12:05 A coalition of drug manufacturers, infectious disease experts, and public health advocates is urging U.S. lawmakers to pass legislation to spur the development of critically needed antibiotics. The coalition sent a letter to the leaders of several congressional panels, including the Senate Finance Committee and the House Subcommittee on Health, warning that certain incentives must be passed in 2019 to meet patient needs and "help mitigate a public health crisis." Of 42 antibiotics now in clinical development, only 11 target the pathogens on the World Health Organization's list of priority pathogens, and only two will likely make it to market. A key hurdle is inadequate economic incentives for making new antibiotics. Some smaller biopharmaceutical and biotech companies are working on developing new antibiotics with backing from agencies like the Biomedical Advanced Research and Development Authority and public-private partnerships like CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), but they lack the financial resources to get drug candidates through late-stage clinical development, FDA approval, and to the market. Advocates say new incentives should include a mix of tax incentives, novel "pull" incentives that raise the value of new antibiotics, and changes in how pharmaceutical companies are reimbursed for antibiotics. (Click for more...) With safety data, Bayer could challenge Erleada, Xtandi in prostate cancer: analyst 2/15/2019 11:40:17 AM For years, Johnson & Johnson and the Pfizer-Astellas team have been the only players in their class of prostate-cancer fighters. But Bayer is waiting in the wings, and stellar new safety data could make it a threat. (Click for more...) Egalet's 70% price increase shows the buy-and-hike strategy is alive and well 2/15/2019 10:14:53 AM While Big Pharma's price increases these days are in the single digits—and still triggering Twitter outrage—some small companies aren't shying away from the old strategy of acquiring drugs and jacking up their prices. (Click for more...) Dr. Reddy's racks up more repeat violations at Bachupally formulations plant 2/15/2019 10:03:42 AM Dr. Reddy’s, which has been struggling to bring a number of its key plants up to FDA standards, has been unable to learn from past mistakes, including at its formulations plant in Bachupally. (Click for more...) FiercePharmaAsia—AstraZeneca’s China business; Pfizer Japan valsartan recall; Xofluza resistance 2/15/2019 6:41:13 AM AstraZeneca's China business soared 25% in 2018 as cancer and respiratory drugs pulled through; Pfizer Japan is recalling valsartan combo drugs made using Mylan's tainted API; Japanese doctors recorded resistance to Shionogi and Roche's novel flu drug Xofluza; and more. (Click for more...) Swayed by discounts, NICE finally backs Roche's Perjeta for postsurgery breast cancer 2/15/2019 2:45:31 AM Looks like the third time was a charm for Roche’s Perjeta when it comes to stepped-up use in England. Thanks to new discounts, the cost-effectiveness watchdogs at NICE recommended the drug for use after surgery in certain HER2-positive breast cancer patients. (Click for more...) Amino Acid Products 2/14/2019 7:00:00 PM Drug: Amino Acid Products, Revision Date: Fri, 15 Feb 2019 (Click for more...) Amiodarone Injection 2/14/2019 7:00:00 PM Drug: Amiodarone Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Ascorbic Acid Injection 2/14/2019 7:00:00 PM Drug: Ascorbic Acid Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Buspirone Tablets 2/14/2019 7:00:00 PM Drug: Buspirone Tablets, Revision Date: Fri, 15 Feb 2019 (Click for more...) Clindamycin Phosphate Injection 2/14/2019 7:00:00 PM Drug: Clindamycin Phosphate Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Diltiazem Extended-Release Capsules (Twice-Daily Dosing) 2/14/2019 7:00:00 PM Drug: Diltiazem Extended-Release Capsules (Twice-Daily Dosing), Revision Date: Fri, 15 Feb 2019 (Click for more...) Enalaprilat Injection 2/14/2019 7:00:00 PM Drug: Enalaprilat Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Haloperidol Tablets 2/14/2019 7:00:00 PM Drug: Haloperidol Tablets, Revision Date: Fri, 15 Feb 2019 (Click for more...) Hydroxocobalamin Injection 2/14/2019 7:00:00 PM Drug: Hydroxocobalamin Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Nelarabine Injection 2/14/2019 7:00:00 PM Drug: Nelarabine Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Physostigmine Salicylate Injection 2/14/2019 7:00:00 PM Drug: Physostigmine Salicylate Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Promethazine Injection 2/14/2019 7:00:00 PM Drug: Promethazine Injection, Revision Date: Fri, 15 Feb 2019 (Click for more...) Sodium Fluoride Chewable Tablets 2/14/2019 7:00:00 PM Drug: Sodium Fluoride Chewable Tablets, Revision Date: Fri, 15 Feb 2019 (Click for more...) Thiothixene Capsules 2/14/2019 7:00:00 PM Drug: Thiothixene Capsules, Revision Date: Fri, 15 Feb 2019 (Click for more...) FDA seeks participants for track-and-trace pilot projects 2/14/2019 4:00:37 PM FDA seeks participants for track-and-trace pilot projects Thu, 02/14/2019 - 16:08 caldridgeyoung… Thu, 02/14/2019 - 16:00 “[Pilot projects give] industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain,” FDA said in a February 7, 2019, media release. (Click for more...) Iowa governor to introduce bill to open access to contraception 2/14/2019 11:22:13 AM Iowa governor to introduce bill to open access to contraception Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Gov. Kim Reynolds of Iowa is expected to introduce legislation to enable state residents to obtain birth control drugs at pharmacies without going to a clinic for a prescription first. If the measure becomes law, it would be easier for pharmacists to dispense birth control pills, hormone patches, and vaginal rings. The Iowa Department of Public Health's medical director, who is a physician, would sign a statewide standing order allowing the products' sale to adult patients. That standing order would essentially stand in as a prescription. To participate in the program, pharmacists would be required to undergo training on how to safely dispense and counsel patients. Under Reynolds' plan, a pharmacist could dispense up to a 1-year supply of the eligible contraceptive through the standing order. Rep. John Forbes (D-Urbandale), who works as a pharmacist, predicts it would take pharmacists about 20 hours to complete necessary training to participate in the new birth-control dispensing program. That is about how long it takes to complete mandatory training to provide vaccinations in pharmacies, he says. Some pharmacists would be interested in the new program, he says, but not all would want to go through the training. (Click for more...) FDA drafts guidance on developing drugs for rare chronic digestive disorder 2/14/2019 11:22:13 AM FDA drafts guidance on developing drugs for rare chronic digestive disorder Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 To facilitate the clinical development of drugs and biologics for treating eosinophilic esophagitis (EoE), FDA has released a 13-page draft guidance document that addresses trial population and design, safety and efficacy, clinical outcomes, and pediatric considerations. FDA recommends sponsors "consider stratified randomization based on the presence or absence of baseline strictures" when making population determinations. Furthermore, the guidance recommends that sponsors consider including dietary restrictions as a covariate. For clinical trial designs, FDA has recommended conducting "a randomized, double-blind, placebo-controlled trial design with a prespecified screening period before randomization of patients to confirm eligibility criteria." In addition, the agency said clinical trials intended to support marketing approval of an EoE drug "should evaluate a drug's effect on both signs/symptoms and the related underlying inflammation." The draft guidance outlined five pediatric recommendations based on 2018 research that suggests clinical signs and symptoms in patients with EoE tend to vary with age. "We encourage the inclusion of adolescents (patients 12–17 years of age inclusive) in registration clinical trials, provided that preliminary safety and efficacy data in adult patients support enrollment," FDA said. The draft guidance did not address the clinical development of drugs for the treatment of non-EoE eosinophilic gastrointestinal disorders. (Click for more...) Dems unveil bill to let VA doctors prescribe medical marijuana 2/14/2019 11:22:12 AM Dems unveil bill to let VA doctors prescribe medical marijuana Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Sen. Brian Schatz (D-HI) and Rep. Barbara Lee (D-CA) unveiled on Wednesday legislation that would give physicians at the Department of Veterans Affairs permission to prescribe medical marijuana. The bill would only apply to states that already allow medical marijuana, but it would lift the federal ban in those 33 states for the VA. Schatz said, "This bill gives VA doctors in these states the option to prescribe medical marijuana to veterans, and it also promises to shed light on how medical marijuana can help with the nation's opioid epidemic." Under the measure, the VA would examine how medical marijuana could be used to treat chronic pain, with the hope that prescribing medical marijuana for pain could reduce the need to prescribe opioids. (Click for more...) Surgeon General calls on physicians to take a more proactive role in opioid crisis 2/14/2019 11:22:10 AM Surgeon General calls on physicians to take a more proactive role in opioid crisis Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Physicians should examine their prescribing habits and be more proactive in helping patients dealing with opioid use disorder (OUD), says Surgeon General Jerome Adams, MD. In a commentary in the JAMA Internal Medicine, Adams and Assistant HHS Secretary Brett Giroir, MD, discuss various ways physicians can rethink their role in the opioid crisis. "Health care professionals can promote evidence-based nonopioid, and even nonpharmaceutical, treatments for pain," they write. "They can screen their patients for OUD and OUD risks, such as trauma and adverse childhood experiences. They can refer patients with OUD to receive medication-assisted treatment or, preferably, become medication-assisted treatment prescribers themselves." (Click for more...) Sanofi and Regeneron cut list price of cholesterol drug by 60% 2/14/2019 11:22:10 AM Sanofi and Regeneron cut list price of cholesterol drug by 60% Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 To keep up with competitors, Sanofi and Regeneron Pharmaceuticals said Monday they will reduce the U.S. list price of alirocumab (Praluent) by 60%. The new list price for the cholesterol fighter will be $5,850 a year, matching the list price of Amgen's competing drug, evolocumab (Repatha). Sanofi and Regeneron said the lower-priced alirocumab, which should improve patient access and lower out-of-pocket costs for consumers, will be available for pharmacies to order in early March. (Click for more...) House committee wants answers on why blood pressure drugs made abroad contained carcinogens 2/14/2019 11:22:10 AM House committee wants answers on why blood pressure drugs made abroad contained carcinogens Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 A bipartisan group of representatives on the U.S. House Committee on Energy and Commerce is asking FDA officials to answer questions about drug safety in the wake of a series of recalls of blood pressure drugs contaminated with small amounts of known carcinogens. There have been at least 15 recalls of versions of the blood pressure and heart medications losartan, valsartan, and irbesartan since July. The recalled drugs are part of a large class of drugs called angiotensin II receptor blockers (ARBs), which work by relaxing the blood vessels. FDA inspections revealed problems at Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India. Those factories made the active pharmaceutical ingredients used in the drugs. FDA believes the contamination stemmed from a change in how the drugs' ingredients were made. "Given our concerns in this area, we are requesting that FDA provide committee staff with a briefing on the basis and impact of ARB recalls as well as a briefing on FDA's efforts to conduct foreign inspections and what ongoing challenges currently exist for the agency," the lawmakers wrote in a letter. (Click for more...) Influenza vaccine safe for hospitalized patients 2/14/2019 11:22:08 AM Influenza vaccine safe for hospitalized patients Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 A study published in Mayo Clinic Proceedings suggests that patients who receive the influenza vaccine while hospitalized are no more likely to develop fever or require additional physician or hospital visits after they go home compared with inpatients who do not get vaccinated. Some physicians are reluctant to vaccinate hospitalized patients over potential complications that could require extra care or cause stress. In this study, researchers used data on more than 290,000 U.S. hospitalizations with some 255,000 patients over 3 consecutive influenza seasons. Almost one-half of the patients were vaccinated before arriving at the hospital, while nearly 16% received the influenza vaccine during their stay. Another 27% were never vaccinated, and the remainder received the influenza vaccine at some point after they were discharged from the hospital. Researchers found no meaningful differences in the risk of fevers, repeat hospitalizations, checkups for infections, or outpatient visits during the first week after discharge among the groups. Only 28% of the patients in the study who had not been vaccinated before entering the hospital received the influenza vaccine during their stay, while just 26% of those who left the hospital unvaccinated received the influenza vaccine during that season. (Click for more...) Lewis Drug purchases Shopko pharmacy assets in six communities 2/14/2019 11:22:08 AM Lewis Drug purchases Shopko pharmacy assets in six communities Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Lewis Drug has bought the pharmacy assets of Shopko stores in several South Dakota, Minnesota, and Iowa communities. On Wednesday, Lewis Drug announced it has purchased the prescription files and records from Shopko stores in Madison, Mitchell, and Sisseton, SD; Luverne and St. James, MN; and Ida Grove, IA. The new acquisitions will bring Lewis Drug's total number of pharmacies in the three states to 58. (Click for more...) Performance of CMS' opioid overutilization criteria for classifying OUD or overdose 2/14/2019 11:22:08 AM Performance of CMS' opioid overutilization criteria for classifying OUD or overdose Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Researchers investigated whether the criteria underpinning CMS' opioid Overutilization Monitoring System could effectively pinpoint Medicare subscribers with opioid use disorder (OUD) or at high risk for overdose. The program, launched in 2013, asks that plan sponsors take action—such as utilization review, case management, and dose-dependent safety alerts or reimbursement denials—when they do identify high-risk beneficiaries. To meet the definition, patients must have received opioids with a mean daily morphine equivalent dose of 90 mg from more than three prescribers and three pharmacists or received prescription opioids of the same dose from more than four prescribers. For OUD, high-risk patients were classified as overutilizers if they had a diagnosis of OUD or an overdose within 6–18 months of receiving an opioid prescription. According to the team from the University of Florida College of Pharmacy, however, these criteria demonstrated low sensitivity in identifying high-risk populations. They reached this conclusion after applying the criteria to between 142,036 and 190,320 Medicare beneficiaries who were prescribed opioids from 2011–14 and tracking their outcomes over three overlapping 6-month cycles for each calendar year. The investigators found that the criteria employed by CMS failed to capture most patients with OUD or overdose. Moreover, they wrongly labeled more than one-half of patients as high risk who were not subsequently diagnosed with OUD or overdose. Based on the results, the study authors emphasize the need for different strategies for flagging high-risk patients for the prevention or treatment of OUD. (Click for more...) Buprenorphine coverage in the Medicare Part D program for 2007 to 2018 2/14/2019 11:22:07 AM Buprenorphine coverage in the Medicare Part D program for 2007 to 2018 Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Methadone maintenance for treatment of an opioid use disorder (OUD) traditionally has not been covered under Medicare Part D, which makes access to buprenorphine ever the more important. Even so, researchers from Oregon State University and Oregon Health & Science University have observed that buprenorphine is underutilized in the Medicare system. Based on analysis of data from 2007, 2012, and 2018, a fair share of plans during those years covered buprenorphine. However, the share of plans that covered with no restrictions—such as prior authorization or step therapy—shrank over time. By 2018, 65% of plans restricted coverage for all forms of buprenorphine. The authors suspect that growing use of prior authorization and other stipulations that require prescribers to obtain insurance approval before dispensing likely contribute to the low utilization rate for buprenorphine for OUD treatment. While insurers employ these tactics as a way to control costs, restrictions increased even for cheap generic buprenorphine. According to the researchers, skewed perceptions of drug risk, the stigma of addiction, and financial considerations all may have supported the trend toward low utilization. They note that legislation taking effect next year will widen Medicare coverage to include methadone treatment, but emphasize that more can done now by simply mandating that Part D plans dismantle coverage-related barriers such as prior authorization and step therapy. (Click for more...) Acyclovir labeling now includes details for treating premature infants infected with herpes virus 2/14/2019 11:22:07 AM Acyclovir labeling now includes details for treating premature infants infected with herpes virus Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 Acyclovir—which is typically prescribed to adults for the treatment of herpes simplex virus (HSV) infections—can also be used to treat newborns, according to its latest drug label. The label provides information on recommended usage and dosage in newborns up to 3 months of age. The data that informed this label change came from a study funded by NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Newborns can become infected with HSV during pregnancy, labor, and delivery or shortly after birth if the mother develops genital herpes near the end of her pregnancy. HSV infection in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs. NICHD's Best Pharmaceuticals for Children Act program supports the Pediatric Trials Network (PTN), which studies drugs and therapies commonly prescribed for infants and children but not specifically tested in them. Results from the PTN study that generated data for acyclovir's label change is available online at NICHD's Data and Specimen Hub. (Click for more...) FDA programs aim to improve quality and lower drug costs 2/14/2019 11:22:04 AM FDA programs aim to improve quality and lower drug costs Wed, 02/13/2019 - 19:00 cbaker_admin Thu, 02/14/2019 - 11:22 FDA Commissioner Scott Gottlieb, MD, discussed on Wednesday steps the agency is taking to support efficiency in drug development and FDA's oversight of drug quality. One way to do this, he said, is to recognize a set of agreed-upon "voluntary consensus standards" for pharmaceutical quality to take advantage of collaborative efforts between regulators, industry, and academia that have resulted in nationally and internationally accepted standards for drug quality. To that end, FDA announced a new draft guidance, "CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality." According to Gottlieb, "The guidance proposes a program in which stakeholders and FDA staff will have the opportunity to propose pharmaceutical quality standards for potential recognition by the FDA, providing industry with additional options for pharmaceutical development and manufacturing." The objective, he said, is to encourage development and appropriate use of consensus standards to help further drug development and make the review of drug product applications more efficient. "Once we've recognized a standard, applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and the acceptance criteria," Gottlieb explained. "We'll similarly be able to streamline assessment of applications that reference recognized standards." He noted that the program will not affect standards that are already legally binding—such as provisions of the Federal Food, Drug, and Cosmetic Act relating to the United States Pharmacopeia—but "the proposed program will facilitate recognition of other standards concerning pharmaceutical quality to make the adoption of advances in drug manufacturing and application review more efficient; and encourage innovation in how drugs are manufactured." (Click for more...) Insys opioid reps rapped about boosting scripts by putting docs on the gravy train 2/14/2019 10:52:35 AM An up-tempo rap about boosting prescriptions wouldn’t seem out of place at your average pharma sales meeting. But a video of Insys sales reps, played by prosecutors Wednesday in founder John Kapoor's criminal trial, was a vivid piece of evidence outlining Insys' over-the-top marketing practices. (Click for more...) Merck aims for prostate cancer dominance with 3 new phase 3 Keytruda studies 2/14/2019 10:35:17 AM If Merck gets its way, it won’t be long before the prostate cancer treatment landscape looks pretty different. The company is adding a trio of late-stage studies to its Keytruda program, hoping they'll deliver some new combo approvals. (Click for more...) Albuterol Sulfate Extended-Release Tablets 2/13/2019 7:00:00 PM Drug: Albuterol Sulfate Extended-Release Tablets, Revision Date: Thu, 14 Feb 2019 (Click for more...) Ampicillin Sodium and Sulbactam Sodium Injection 2/13/2019 7:00:00 PM Drug: Ampicillin Sodium and Sulbactam Sodium Injection, Revision Date: Thu, 14 Feb 2019 (Click for more...) Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection 2/13/2019 7:00:00 PM Drug: Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection, Revision Date: Thu, 14 Feb 2019 (Click for more...) Buprenorphine Hydrochloride Injection 2/13/2019 7:00:00 PM Drug: Buprenorphine Hydrochloride Injection, Revision Date: Thu, 14 Feb 2019 (Click for more...) CVS introduces new concept store with more health care, less retail 2/13/2019 1:05:01 PM CVS introduces new concept store with more health care, less retail Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 CVS Health is testing a new concept store format as the company plans to shift more of its floor space to health care services. The community pharmacy chain is debuting three HealthHUB locations in Houston. Part of the concept store is closed-off space for classes, such as yoga, as well as expanded space for health treatments. More than 20% of the floor space at the concept stores is devoted to health care services, including wellness products and personalized care. Pharmacists in the HealthHUB will also make regular calls and in-person consultations with certain patients to help them stay on track with their prescription drug plans. The move comes as CVS integrates newly acquired insurer Aetna and prepares for potential competition with Amazon for pharmacy customers. "By bringing those services to help them better manage their chronic diseases, we can really increase their awareness, their engagement, the experience with those services and ultimately help them manage their own diseases and be healthier, which in turn lowers overall health care costs," says CVS chief transformation officer Alan Lotvin. (Click for more...) Racial differences in opioid overdose deaths in New York City 2/13/2019 1:05:01 PM Racial differences in opioid overdose deaths in New York City Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 Drug overdose fatalities during 2000–11 were dominated by opioid deaths among white users, but data since 2016 suggests that while the rate of deadly overdoses has stabilized, the face of the epidemic has changed. The latest trends are explored by researchers at the New York City Department of Health and Mental Hygiene, who surveyed 2017 data on the age and race of overdose victims as well as the drug implicated in their deaths. Of 1,487 fatal overdoses locally, the team determined that 37% occurred among whites, 31% occurred among Latinos, and 28% occurred among African Americans, with the remaining 4% including other or undefined populations. Digging deeper, they found that overdose deaths for whites were highest among middle-aged and younger individuals. The trend was strongest among younger whites, aged 15–34 years, and older blacks, aged 55-84 years. Young whites were likely to have been addicted for shorter periods of time, to be primary opioid users who graduated to heroin, and to have not been exposed to opioid agonist treatment. Older blacks, to the contrary, were likely to have drug habits going back to the heroin epidemics of the late 1990s and the HIV/AIDS crisis, to be primary heroin users, and to have undergone opioid agonist therapy. Based on this characterization, the researchers say heterogeneous interventions and equitable allocation of treatment and health care resources are needed to reach diverse populations at risk of overdose. (Click for more...) County-level opioid prescribing in the United States, 2015 and 2017 2/13/2019 1:05:01 PM County-level opioid prescribing in the United States, 2015 and 2017 Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 Despite a decline in the number of opioid prescriptions in recent years, prescribing levels continue to be high compared with 1999 volume. CDC researchers analyzed activity on a nationwide and per-county basis for 2015 and 2017 in an effort to inform efforts to improve in this area. Opioid prescribing across the United States fell 20.1% during the study period based on prescribing rates per 100 persons, share of high-dose opioids prescribed, and average daily morphine milligram equivalent (MME) per prescription. The amount of opioids prescribed declined by 10% annually in roughly three-quarters of U.S. counties over those years vs. a decline of just 3.6% annually in just under one-half of all counties during 2010–15. A number of factors, from CDC's 2016 opioid guidelines for chronic pain to increased awareness of the risks of opioids, are attributed for the lower numbers; however, these influences did not knock down the average and medium duration of prescriptions. As of 2017, opioids were prescribed at 512.6 MME per capita, nearly three times the amount prescribed in 1999. This exception to the overall downward trend is likely due to a bigger drop in shorter-term opioid prescriptions than in longer-term orders. (Click for more...) United Healthcare cites success in limit on opioid dental prescriptions for ages 19 years or younger 2/13/2019 1:05:01 PM United Healthcare cites success in limit on opioid dental prescriptions for ages 19 years or younger Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 M. Ted Wong, DDS, MHA, chief dental officer at United Healthcare, says the company's 4-month old policy that limits first-time opioid prescriptions to 3 days for dental patients aged 19 years or younger to has been successful. He says prior to implementing the policy, United Healthcare had a 7-day limit on opioids—and that remains in effect for adults. Wong says, "We have seen a 90% reduction in (prescriptions) that exceeded the CDC guidelines. Some prescriptions still exceed the requirements. We have a prior authorization and a waiver policy for (dental providers) who feel their patients require more days." The policy took effect on October 1 in an effort to curb unnecessary opioid use, and it also limits dosages to fewer than 50 morphine milligram equivalents per day. In conjunction with a dental professional education program, dentists and oral surgeons have reduced opioid prescriptions by 17% for all ages of patients, according to Wong. He says United Healthcare examined claims and found that dentists and oral surgeons were writing 12% of all opioid prescriptions, including 45% of prescriptions for children and adolescents under age 19 years. Wong points out that more than two-thirds of wisdom teeth extractions for people aged 16–22 years result in at least one prescription for an opioid. (Click for more...) Democratic chair asks FDA for documents on powerful new opioid 2/13/2019 1:05:01 PM Democratic chair asks FDA for documents on powerful new opioid Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 Democratic lawmakers are requesting documents from FDA as they probe the agency's controversial decision to approve a powerful new opioid sufentanil citrate (Dsuvia—AcelRx Pharmaceuticals). Advocates and some lawmakers had warned against approving a powerful new opioid amid the opioid epidemic. The drug is 10 times more powerful than fentanyl and 1,000 times more powerful than morphine. DeGette and Markey expressed concern sufentanil citrate could be abused, saying it can "deliver a potency that has been known to be lethal in small dosages." In November when announcing the approval of the drug, FDA Commissioner Scott Gottlieb acknowledged its potential dangers but said it could be beneficial to the military. He noted that the drug can be administered under the tongue, which could be helpful on the battlefield in situations where injecting a drug is difficult. (Click for more...) 'Charlie's Law' to require NJ pharmacists to inform patients of safe disposal of medication 2/13/2019 1:05:01 PM 'Charlie's Law' to require NJ pharmacists to inform patients of safe disposal of medication Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 New Jersey's legislature is considering a measure to require pharmacists in the state to educate patients on how to safely discard unused, unwanted, or expired drugs and needles. Bill S3240 is known as "Charlie's Law" in memory of Charlie Van Tassel, who battled addiction for several years before passing away at age 33 years. The bill calls for requiring pharmacists to provide instructions to warn patients of potential risks if their medication is not discarded safely. Pharmacists would also be required to make available a deactivation product that can neutralize 98% of drugs. Edward Thomson, one of the bill's sponsors, says: "Pharmacists can provide valuable education so that their patients don't become part of or contribute to unsettling statistics." One in three people nationwide has expired or unused medication in their home, which may fall into the wrong hands or get into landfills or water supplies, Assembly Republicans note. More than 70% of people abusing opioids for nonmedical uses obtain them from family or friends, according to surveys conducted for the National Household Survey on Drug Use and Health. In addition, 55% of people say they obtained the drugs for free, another 11% purchased them, and 5% received them without asking. (Click for more...) Gottlieb discusses efforts to secure U.S. drug supply chain, cites warning letter to McKesson 2/13/2019 1:05:01 PM Gottlieb discusses efforts to secure U.S. drug supply chain, cites warning letter to McKesson Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 FDA Commissioner Scott Gottlieb discusses the agency's efforts to stop the spread of illicit opioids and further secure all aspects of the supply chain for legitimate medications, including opioids. On Tuesday, the agency announced it has issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for violations highlighted by a concerning tampering incident that involved opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder, and high blood pressure. In one instance outlined in the letter, McKesson was notified by a pharmacy customer that multiple of their pharmacy locations received bottles that were supposed to contain potent opioid tablets. However, once opened, the pharmacies discovered that bottles at three pharmacy locations did not contain the correct medications, and the opioid pills were missing, having been replaced with other non-opioid medications. The pharmacy customer notified McKesson about the discovery of illegitimate products. While McKesson's internal investigation noted that it was likely the opioid medication was replaced while in their possession or control, McKesson did not sufficiently respond to the notification that it may have distributed illegitimate products, according to Gottlieb. (Click for more...) Paracetamol and ibuprofen and morphine consumption after THA 2/13/2019 1:05:01 PM Paracetamol and ibuprofen and morphine consumption after THA Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 New research shows that for individuals undergoing total hip arthroplasty (THA), the combination of paracetamol and ibuprofen led to substantial reductions in morphine consumption compared with paracetamol alone in the first 24 hours following surgery. Data for the PANSAID randomized clinical trial, which involved more than 500 individuals undergoing THA, found no statistically significant rise in serious adverse events in the pooled groups that received only ibuprofen compared with those receiving only paracetamol. The researchers note, however, that the combination of the two drugs did not demonstrate a clinically important improvement compared with only ibuprofen. This suggests that using "ibuprofen alone may be a reasonable option for early postoperative oral analgesia," the authors conclude. (Click for more...) FDA panel recommends new depression treatment 2/13/2019 1:05:01 PM FDA panel recommends new depression treatment Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 An FDA advisory panel recommended on Tuesday the approval of a nasal spray that contains the active ingredient of ketamine for the treatment of depression. Esketamine, from Johnson & Johnson, is intended for individuals with severe depression, especially those considering suicide. The 17-member panel was nearly unanimous in its decision that the drug's benefits outweighed its risks. FDA, which typically follows the recommendations of its expert panels, is expected to make its decision about esketamine by March 4. (Click for more...) WHO warns of falsified versions of cancer drug ponatinib 2/13/2019 1:05:01 PM WHO warns of falsified versions of cancer drug ponatinib Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 The World Health Organization (WHO) is cautioning health care professionals, regulators, and industry to be alert for fake versions of ponatinib (Iclusig—Takeda and Incyte). Swiss health officials informed the WHO on January 15 that a local wholesaler had bought packs of Iclusig 15 mg, but it was later determined the packs were falsified. According to the WHO, further investigation revealed there are two counterfeit versions of the leukemia drug being sold, including online. The 15 mg and 45 mg strengths of the drug were both found to contain paracetamol. In a statement, Takeda said: "We are in discussions and collaborating closely with our partner Incyte, who codevelops and commercializes Iclusig across Europe, to monitor and remedy the situation and to minimize any potential supply disruption to patients and health care professionals. Counterfeit batches of Iclusig originated from a Turkish wholesaler and were distributed to multiple regions, including Turkey, Switzerland and Argentina. At this time, no U.S. product has been found to be counterfeit. We cannot predict if other countries or regions will be impacted, but we are working diligently to investigate the issue and minimize any potential supply disruption to patients and health care professionals." Takeda and Incyte noted they did not manufacture or supply the products, and the batch numbers do not correspond to those for authentic manufacturing records. The WHO's warning notice stated, "WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products." (Click for more...) Study links psoriasis treatment and improvement in heart artery disease 2/13/2019 1:05:01 PM Study links psoriasis treatment and improvement in heart artery disease Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 A study published online in Cardiovascular Research reveals that treating psoriasis—which is associated with heightened systemic inflammation—with biologic drugs can reduce early plaque buildup in arteries. The study findings came from an observational study of the NIH Psoriasis Atherosclerosis Cardiometabolic Initiative cohort, which had 290 psoriasis patients, of whom 121 had moderate-to-severe skin disease and qualified for the biologic therapy approved by the FDA. Researchers followed eligible patients for a year and compared them with those who elected not to receive biologic therapy. Study results indicated that biologic therapy was associated with an 8% reduction in coronary artery plaque. Nehal N. Mehta, MD, head of the Lab of Inflammation and Cardiometabolic Diseases at NHLBI, observed: "Classically a heart attack is caused by one of five risk factors: diabetes, hypertension, high cholesterol, family history, or smoking. Our study presents evidence that there is a sixth factor, inflammation; and that it is critical to both the development and the progression of atherosclerosis to heart attack." (Click for more...) Rutgers study finds rise in overdoses from opioids in diarrhea drug 2/13/2019 1:05:01 PM Rutgers study finds rise in overdoses from opioids in diarrhea drug Tue, 02/12/2019 - 19:00 cbaker_admin Wed, 02/13/2019 - 13:05 Overdoses of the OTC diarrhea drug loperamide are increasing, according to new research from Rutgers University. The study notes that loperamide is available both online and in stores and is undetectable on routine drug tests. "When used appropriately, loperamide is a safe and effective treatment for diarrhea—but when misused in large doses, it is more toxic to the heart than other opioids which are classified under federal policy as controlled dangerous substances," said senior author Diane Calello, executive and medical director of the New Jersey Poison Control Center at Rutgers University Medical School. "Overdose deaths occur not because patients stop breathing, as with other opioids, but due to irregular heartbeat and cardiac arrest." Published in Clinical Toxicology, the study found increasing instances in which patients with opioid use disorder misused loperamide to prevent or self-treat withdrawal symptoms. The researchers reviewed cases of patients with loperamide exposure reported by medical toxicologists to the Toxicology Investigators' Consortium, from January 2010 to December 2016. The Poison Control Center database reported a 91% increase during that time period. Most of the cases involved very high doses of loperamide, the equivalent of 50–100 2-mg tablets per day. (Click for more...) Amphotericin B Injection 2/12/2019 7:00:00 PM Drug: Amphotericin B Injection, Revision Date: Wed, 13 Feb 2019 (Click for more...) Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution 2/12/2019 7:00:00 PM Drug: Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution, Revision Date: Wed, 13 Feb 2019 (Click for more...) Fluorescein Sodium Ophthalmic Strips 2/12/2019 7:00:00 PM Drug: Fluorescein Sodium Ophthalmic Strips, Revision Date: Wed, 13 Feb 2019 (Click for more...) Penicillamine 2/12/2019 7:00:00 PM Drug: Penicillamine, Revision Date: Wed, 13 Feb 2019 (Click for more...) Online Exclusive: Time management tips to relieve stress 2/12/2019 3:02:48 PM Online Exclusive: Time management tips to relieve stress Thu, 02/14/2019 - 12:00 tenglish@aphanet.org Tue, 02/12/2019 - 15:02 By Sajida Gowani Since you all have been trying to start the spring semester and new year on the right foot, I thought it would be beneficial to share some helpful insights and tips on time managemen...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Measles cases nationwide rise to 101, CDC says 2/12/2019 12:05:01 PM Measles cases nationwide rise to 101, CDC says Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 CDC reported Monday that 101 cases of measles have been confirmed in 10 U.S. states so far this year. Most of the cases are among people who have either not been vaccinated or who only received one dose of vaccine. As of February 7, 55 of those cases were confirmed in Washington state. Most of those cases are among children younger than age 10 years whose parents had decided not to have them vaccinated. The measles vaccine is 97% effective when both doses are administered. (Click for more...) Ketamine could be the key to reversing America's rising suicide rate 2/12/2019 12:05:01 PM Ketamine could be the key to reversing America's rising suicide rate Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 With suicide rates climbing in the United States, even as they decline worldwide, new hope for a "cure" is growing. That optimism is attached to ketamine, which was introduced as an anesthetic decades ago and more recently gained a reputation as a club drug. Now, pharmaceutical companies are eyeing it as a way to treat depression that does not respond to conventional therapy. Researchers began looking at ketamine in this light in the mid-1990s, more than 20 years after it was indicated for anesthesia. Progress was slow, with little interest in funding work involving an old and inexpensive drug, but interest gradually picked up and the findings began to trickle in. An NIH study in 2006 found that a single dose of ketamine provided "robust and rapid antidepressant effects" within just 2 hours, while at least one later investigation documented rapid alleviation of suicidal thoughts in as little as 40 minutes. As the evidence mounted, ketamine clinics began to surface around 2012 in large metropolitan areas, where customers pay about $500 for an infusion—a potential solution for those with the financial means and access to the centers. For those without one, the other, or both, there is still hope. The first FDA approval of a ketamine-based drug could come as early as this spring; and a formulation to treat suicidal thinking could be sanctioned within 2 years. Meanwhile, work continues to develop a better version of the drug, whose precise treatment pathway, safety, and long-term effects remain uncertain. (Click for more...) DoD and civilian doctors, pharmacies now sharing information about opioid prescriptions, watching for abuse 2/12/2019 12:05:01 PM DoD and civilian doctors, pharmacies now sharing information about opioid prescriptions, watching for abuse Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 Defense health officials have unveiled the Military Health System Prescription Drug Monitoring Program to identify possible opioid and other drug abuse problems in military patients. Navy Vice Adm. Raquel C. Bono, director of the Defense Health Agency, said the program "will allow civilian and military providers to review patient opioid prescription histories to ensure there are no overlapping opioid prescriptions that can worsen an opioid use disorder or cause an overdose." Prescription drug monitoring programs have allowed medical providers and pharmacies to track how many controlled substance prescriptions a patient receives. Before the new program, it was a challenge for the Department of Defense to provide this data to the states, and to get data from the states, due to operational security. Defense Health Agency officials are negotiating agreements with the states to begin sharing prescription data. So far, nine states and territories have signed on to share data, but the plan is to have all states connect to the network soon. (Click for more...) Being the 'go-to' pharmacy for diabetes care 2/12/2019 12:05:01 PM Being the 'go-to' pharmacy for diabetes care Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 Less than one-half of people with diabetes achieve adequate glycemic control and the desired blood glucose goal of 7%, says Jerry Meece, director of clinical services at Plaza Pharmacy and Wellness Center in Gainesville, TX. He says community pharmacists are ideally positioned to become the "go-to" pharmacy for diabetes care. Such pharmacies stock a higher level of diabetes supplies and their staff members support the pharmacist in caring for the diabetes patient. To this end, staff delegate repetitive jobs, while a "chief diabetes technician" could demonstrate and troubleshoot blood glucose meters, leaving the pharmacist free to discuss the results of blood glucose values, for example, with patients. Another effective tool is motivational interviewing based on such things as open-ended questions, empathy, and reflective listening. According to Meece, "The successful 'go-to' diabetes pharmacy will become as creative in working with its diabetes patients as the airlines are in dealing with their best customers. The end result is a pharmacy that is recognized throughout the professional, as well as the lay community, as a resource for all areas of diabetes care." (Click for more...) FDA to strengthen regulation of dietary supplements 2/12/2019 12:05:01 PM FDA to strengthen regulation of dietary supplements Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 FDA on Monday announced a new plan with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. "To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products," said FDA Commissioner Scott Gottlieb. He said the agency's new plan includes "communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies, and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders." As part of its comprehensive efforts, the agency on Monday sent 12 warning letters and five online advisory letters to companies whose products—many of which are marketed as dietary supplements—are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat, or cure Alzheimer disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. (Click for more...) FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer disease 2/12/2019 12:05:01 PM FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer disease Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 FDA said Monday it has sent more than a dozen warning letters to companies that are illegally selling products—many sold as dietary supplements—that are unapproved new drugs and/or misbranded drugs that claim to prevent, treat, or cure Alzheimer disease and other serious health conditions. According to the agency, "These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat." FDA Commissioner Scott Gottlieb, MD, said: "Today's actions are part of the FDA's larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act, enacted by Congress 25 years ago." The more than 58 products cited in the 12 warning letters and 5 online advisory letters include a number of product types, including tablets, capsules, and oils. The companies have been asked to respond to FDA within 15 days of receipt of the letters with details of how they plan to correct the violations. Failure to respond promptly could result in legal action, FDA said. (Click for more...) Ohio lawmakers resume push for transparency, end to gag rules by PBMs 2/12/2019 12:05:01 PM Ohio lawmakers resume push for transparency, end to gag rules by PBMs Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 Ohio state Reps. Scott Lipps (R-Franklin) and Thomas West (D-Canton) have reintroduced legislation aimed at lowering prescription drug costs by increasing price transparency for both consumers and pharmacists. The state House passed the legislation unanimously last year, but after receiving an initial hearing in December, it failed to clear the Senate before the session ended December 31. The latest effort to rein in PBMS comes a week after Gov. Mike DeWine ordered the Department of Medicaid to rebid contracts with managed care companies that hire PBMs to negotiate drug prices with manufacturers and rates paid to pharmacists to fill prescriptions. Lipps and West’s bill would make permanent in state law the regulations imposed on PBMs last year by the Insurance Department. Specifically, the bill would prohibit PBMs from directing pharmacists to charge patients more than the price of a drug without insurance, and ban "gag rules" that prevent pharmacists from telling their customers about cheaper options for buying medication. (Click for more...) New rules could ease patients' access to their own health records 2/12/2019 12:05:01 PM New rules could ease patients' access to their own health records Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 CMS Administrator Seema Verma says new federal proposals mandate that patients be able to electronically access all of their health information held in a provider's electronic record. In addition, health insurers offering government-backed plans such as Medicare Advantage, managed Medicaid, and Affordable Care Act exchange coverage would be required to open up new digital pathways to claims data for consumers. Such data could then be integrated into tools such as Apple devices. Other companies trying to facilitate patients access to their health information include Ciitizen, Seqste, and PicnicHealth. Verma says she would encourage insurers to offer the same service in employer plans. The federal government says at least 97% of hospitals have electronic health records, which can help improve patient care and convenience as well as develop valuable new artificial-intelligence-powered health care tools and allow drug-industry studies of the real-world effects of medicines. The new proposals have seven exceptions, such as if a health data request would impose an unreasonable burden or violate privacy practices. The proposals would also set new limits on health-data holders' ability to charge other companies for access and generally ensure the sharing of screenshots. Hospitals would also be required to provide digital notifications to patients' other providers when they are admitted, transferred, or discharged. (Click for more...) Rural Colorado residents may soon be able to visit pharmacy of their choice 2/12/2019 12:05:01 PM Rural Colorado residents may soon be able to visit pharmacy of their choice Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 Colorado state Rep. Marc Catlin (R-Montrose) has proposed legislation that would allow state residents to get prescription drugs covered by insurance at the pharmacy of their choice. Backed by the bill, rural residents could pick a local pharmacy instead of traveling hours or miles to another one, and patients could maintain long-standing relationships with pharmacists. Advocates for the bill describe it as a common-sense measure passed by 26 states. But opponents warn the dismantling of chain community pharmacies' relationships with insurance companies and PBMs would drive up the cost of prescription drugs. Last year, a version of Catlin’s bill passed the House but died in the Senate in the face of opposition from business associations like the Colorado Chamber of Commerce and companies such as CVS Health and Express Scripts. Catlin’s bill is expected to be heard by the House Health and Insurance Committee next week. (Click for more...) Progress erased: Youth tobacco use increased during 2017-18 2/12/2019 12:05:01 PM Progress erased: Youth tobacco use increased during 2017-18 Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 Increasing use of e-cigarettes led to a reversal in progress in reducing youth tobacco product use last year, CDC reported Monday. A new Vital Signs report shows that some 4.9 million middle and high school students reported current use of some type of tobacco product in 2018, an increase from 3.6 million in the previous year. Aside from e-cigarettes, the data show no change in the use of other tobacco products, including cigarettes. However, there were 1.5 million more youth e-cigarette users last year compared with 2017, and those who were vaping used the devices more often. Frequent use (defined as more than 20 days in the past 30 days) of e-cigarettes rose from 20% in 2017 to 28% last year among current high school e-cigarette users. Last year, 27.1% of high school students and 7.2% of middle school students reported current use of a tobacco product, with e-cigarettes the most popular among both groups, used by 20.8% and 4.9%, respectively. The data also indicate that many youth tobacco product users use multiple products, with about 2 in 5 high school students and 1 in 3 middle school students reporting use of two or more tobacco products in 2018. The most common combination in both groups was use of e-cigarettes and conventional cigarettes. "The skyrocketing growth of young people's e-cigarette use over the past year threatens to erase progress made in reducing youth tobacco use. It's putting a new generation at risk for nicotine addiction," said CDC Director Robert R. Redfield, MD. "Despite this troubling trend, we know what works and we must continue to use proven strategies to protect America's youth from this preventable health risk. Youth use of any tobacco product, including e-cigarettes, is unsafe." FDA Commissioner Scott Gottlieb, MD, added: "These data are a sobering reminder of the rampant rise of youth e-cigarette use. I fear this trend will continue in 2019, forcing us to make some tough decisions about the regulatory status of e-cigarettes." (Click for more...) 24-hour influenza medication may not be miracle drug doctors thought 2/12/2019 12:05:01 PM 24-hour influenza medication may not be miracle drug doctors thought Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 An influenza treatment hailed as a panacea in Japan for its ease of use and far-reaching efficacy has been little used in the United States since being approved last year. Physicians here point to the relative novelty of baloxavir marboxil (Xofluza—Shionogi) and its expensive price tag for the slow takeup; and, now, there is emerging evidence that the medication delivers inconsistent results. As of February 6, Tokyo's National Institute of Infectious Diseases reports detecting six strains that appear to be resistant to the drug. Genentech, which markets Xofluza in the United States, said further study is warranted to determine the extent of the problem and the transmissibility of the mutant strains. A global study of how the medication affects the spread of influenza is launching this year. “There is the possibility that Xofluza will not be effective in the next [influenza] season if it is widely used now, as this will cause drug-resistant viruses to spread quickly,” warned Naoto Hosokawa, head of the infectious disease department at Kameda Medical Center, which reportedly is not prescribing Xofluza. Meanwhile, Shionogi confirmed that it initially produced 8 million doses of the drug and intends to manufacture 1 million more doses by the close of influenza season. (Click for more...) Assessment of racial/ethnic and income disparities in the prescription of controlled medications in California 2/12/2019 12:05:01 PM Assessment of racial/ethnic and income disparities in the prescription of controlled medications in California Mon, 02/11/2019 - 19:00 cbaker_admin Tue, 02/12/2019 - 12:05 In a new study, researchers from UCLA investigated whether differential prescribing of opioids by race/ethnicity and income class explains opioid overdoses concentrated among low-income white communities. The population-based study used records from California's prescription drug monitoring program from 2011–15. The database contained unique records for 29.7 million individuals who received controlled substance prescriptions during that time. According to the data, there was a nearly 300% difference in prevalence in opioid prescriptions across the race/ethnicity–income gradient, with 44.2% of adults in the quintile of adults with zip code tabulation areas (ZCTAs) with the lowest/highest proportion–white population receiving at least one opioid prescription per year. In the quintile with the highest-income/lowest proportion–white population, 16.1% received at least one opioid prescription. Among all individuals aged 15 years or older, 23.6% received at least one opioid prescription. In predominantly white high-income areas, there was a high concentration of stimulant prescriptions, with a prevalence of 3.8% among individuals in the quintile with the highest-income/highest proportion–white population and a prevalence of 0.6% in the quintile with the lowest-income/lowest proportion–white population. While there was no income gradient for benzodiazepines, they were concentrated in mostly white areas. Specifically, 15.7% of adults in the quintile of ZCTAs with the highest proportion–white population received at least one prescription a year vs. 7.0% among the quintile with the lowest proportion–white population. The researchers note, "Our results suggest that race/ethnicity and income are key factors by which variations in prescription prevalence may be understood. This study represents one of the first population-level efforts, to our knowledge, to quantify the social patterns of prescription drug use." (Click for more...) Modification to clozapine REMS takes place February 28 2/12/2019 11:52:57 AM Modification to clozapine REMS takes place February 28 Tue, 02/12/2019 - 11:56 caldridgeyoung… Tue, 02/12/2019 - 11:52 Other changes, which are outlined in more detail on FDA’s website as well as on a program update page issued by the Clozapine Product Manufacturers’ Group (CPMG), include: (Click for more...) With no ‘magic bullet’ for colds, patience is key 2/12/2019 11:46:50 AM With no ‘magic bullet’ for colds, patience is key Tue, 02/12/2019 - 11:48 caldridgeyoung… Tue, 02/12/2019 - 11:46 “The common cold is a self-limiting benign condition that usually lasts 7 to 10 days,” said lead study author Mieke L. van Driel, MD, PhD. Noting that the human body itself provides the best defense against colds, she added: “In healthy people who are not taking immunosuppressant medication, our immune system can easily deal with it. However, we need to give it time. It usually takes 1 to 2 weeks to get better.” (Click for more...) Bill would lower age for kids to get vaccines at pharmacies instead of doctor's office 2/11/2019 11:38:38 AM Bill would lower age for kids to get vaccines at pharmacies instead of doctor's office Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 In Montana, House Bill 231 would allow pharmacists in the state to give most types of vaccines to children aged 7 years and older. State Rep. Casey Knudsen (R-Malta), who sponsored the bill, noted that getting a child to a doctor's office in rural parts of the state can be time-consuming and expensive. "If all they want is to get a vaccine, they should be able to just get a vaccine. They shouldn't have to sit in a waiting room for an hour and go through all the other screenings if that's not what they're there for," Knudsen said Wednesday in front of the House Human Services Committee. However, some opponents of the bill suggested the bill could lead to gaps in reporting if patients have had immunizations from a pharmacy, while others noted the complexity of childhood vaccines and questioned the safety of delivery of vaccines in a pharmacy setting. (Click for more...) E-prescribing bounces back after hurricanes only if infrastructure does too 2/11/2019 11:38:36 AM E-prescribing bounces back after hurricanes only if infrastructure does too Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 The e-prescription system recovered quickly after hurricanes Harvey and Irma, but it took much longer after Hurricane Maria, most likely due to long-lasting power outages, according to a new study in Health Affairs. To see if electronic records have improved access to medications and medical information after natural disasters, researchers analyzed prescription-related records kept by Surescripts from areas directly affected by three major storms in 2017. In Houston, an average of 63,200 e-prescribing transactions occurred daily before Hurricane Harvey hit. In the days immediately after the storm, that level dropped as low as 8,000; but the level was back up to an average of 64,300 per day after 9 business days. In a sample of major Florida cities, average daily transactions were at 121,700 before Irma hit. They dropped by 95% in the aftermath of the storm but were back up to 123,000 about 2 weeks later. While the system appeared to start recovering within days of Harvey and Irma, it had not yet returned to normal in Puerto Rico by the end of the study period. Before Maria hit the island on September 20, 2017, average daily e-prescription transactions numbered 56,500. In the days just following the storm, that fell to fewer than 100—and even 8 months later, the number had only returned to a peak of 51,600. According to lead author Jaime Smith of Surescripts, a report from the Federal Emergency Management Agency blamed the problems in Puerto Rico on "infrastructure difficulties," as the other areas were able to restore power much more quickly. (Click for more...) Feds halt two Tennessee pharmacies' opioid dispensing for now 2/11/2019 11:38:36 AM Feds halt two Tennessee pharmacies' opioid dispensing for now Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 U.S. Attorney Donald Cochran said Friday that the Justice Department has a taken first-of-its-kind action to temporarily stop two Tennessee pharmacies, their owner, and three pharmacists from dispensing opioids and other controlled substances. The federal prosecutor said Celina, TN-based Oakley Pharmacy, known as Dale Hollow Pharmacy, and Xpress Pharmacy of Clay County illegally filled thousands of opioid and other prescriptions without legitimate medical purpose. Two people have died and numerous others were hospitalized for overdoses shortly after obtaining drugs from the pharmacies, according to Cochran's office. Filings from the prosecutor say Thomas Weir, who owns both pharmacies, oversaw operations and pharmacists Michael Griffith, John Polston, and Larry Larkin illegally filed prescriptions. "The action supported today by the Drug Enforcement Administration should serve as a warning to those in the pharmacy industry who choose to put profit over customer safety," said a statement from D. Christopher Evans, special agent in charge of DEA's Louisville Field Division. That division covers Tennessee, Kentucky, and West Virginia. A judge signed an order to keep the pharmacies and four men from dispensing controlled substances and will soon set a hearing to consider a permanent injunction. (Click for more...) FDA adds new steps to process for issuing public warnings and notifications of recalls 2/11/2019 11:38:36 AM FDA adds new steps to process for issuing public warnings and notifications of recalls Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 FDA Commissioner Scott Gottlieb reports the agency is taking new steps to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls. The new guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. It also describes FDA's policy for moving forward with posting recalls to FDA's Enforcement Report, in some cases before a final health hazard evaluation is completed. Agency officials are also evaluating how new technologies might be used to notify consumers if they have purchased a product that is later recalled. (Click for more...) U.S. travelers seek cheaper prescription drugs in Mexico and beyond 2/11/2019 11:38:34 AM U.S. travelers seek cheaper prescription drugs in Mexico and beyond Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 The U.S. government estimates that nearly 1 million people in California alone cross to Mexico annually for health care, including to buy prescription drugs. Between 150,000 and 320,000 Americans a year list health care as a reason for traveling abroad, with cost savings most commonly cited as the reason. In Utah last year, the Public Employee Health Plan (PEHP) included a voluntary Pharmacy Tourism Program. For certain PEHP members who use any of 13 costly prescription medications, the insurer will pay the bill to fly the patient and a companion to San Diego, then drive them to a hospital in Tijuana, Mexico, to pick up a 90-day supply of medicine. The program was part of a Right to Shop bill championed by health care economist and Utah state Rep. Norm Thurston in 2018. Thurston says there is not yet enough data to know how much in savings the program provides; the first patients traveled to Tijuana in December. The Utah program sends its patients only to a designated, accredited Mexican hospital. (Click for more...) Pharmacists for Healthier Lives continues to grow 2/11/2019 11:38:34 AM Pharmacists for Healthier Lives continues to grow Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 Four state pharmacy associations—the Nebraska Pharmacists Association, the Iowa Pharmacy Association, the Illinois Pharmacists Association, and the Indiana Pharmacists—have joined Pharmacists for Healthier Lives. Along with the current state association member, the Georgia Pharmacy Association, the four newly joined associations will participate in the group's public awareness initiative to educate consumers and policymakers about pharmacists' important contributions, in such areas as medication management and improving patient outcomes. "The addition of these state pharmacy organizations to our growing coalition is a major step forward in building a nationwide network of health care professionals to promote the important work our nation's pharmacists do each day," said Lucinda Maine, executive vice president and CEO of AACP. "With their help, our coalition will continue to promote the full-range of expertise and services pharmacists provide and the great impact they make on people's lives through patient education, prescriber consultations and community service National pharmacy organizations participating in the coalition include the American Society of Health-System Pharmacists, the Academy of Managed Care Pharmacy, the Accreditation Council for Pharmacy Education, the National Alliance of State Pharmacy Associations, and PrescribeWellness. (Click for more...) FDA alerts more doctors of rare cancer with breast implants 2/11/2019 11:38:33 AM FDA alerts more doctors of rare cancer with breast implants Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 FDA has issued a letter to health professionals about a form of lymphoma that affects breast implant patients. There is no consensus on the frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates range from 1 in 3,000 patients to 1 in 30,000 patients. FDA's decades-old electronic database relies on hand-typed submissions from companies, doctors, patients, and lawyers. Agency officials said since 2010, they have identified 457 likely cases of the cancer, including 9 patient deaths. The disease was diagnosed in each of these cases by a physician or via laboratory testing. FDA's warning applies to all types of breast implants, although experts in the United States and overseas have focused on a type known as textured implants that have a sandpaper-like coating. Alan Matarasso, MD, FACS, president of the American Society of Plastic Surgeons, notes: "The vast majority—if not all of the cases—have been in patients that at some point had some form of a textured implant." FDA recommends conducting laboratory testing to confirm or rule out of the disease in suspected cases. The warning is the first from regulators to physicians other than plastic surgeons. The lymphoma usually forms in the scar tissue that forms around implants. The earliest signs of the disease are usually lumps, swelling, and pain around the breasts. (Click for more...) A high-tech capsule to end drug injections 2/11/2019 11:38:33 AM A high-tech capsule to end drug injections Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 Scientists at MIT, Harvard, and Novo Nordisk have developed a tiny robotic capsule that injects insulin once it lands in the stomach. The device works in rats and pigs, the researchers report in Science, and they hope to start testing it in humans in 3 years. To create a capsule that lands in the stomach in a predictable way, scientists modeled the test device—called Soma—after the angled shell of a leopard tortoise, which always rights itself after rolling over. The shape means it will always land on the wall of the stomach, in the right orientation, no matter how it falls down the esophagus. Inside the device is a miniature post made of insulin. After the device positions itself against the stomach wall, the post pops out and injects insulin. The device then travels through the colon and eventually is eliminated by the patient. (Click for more...) Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors 2/11/2019 11:38:31 AM Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 After previously reporting interim results for the ANNEXA-4 clinical trial, which evaluated andexanet alfa as a treatment for bleeding associated with factor Xa inhibitors, researchers have made the full results available. The study sample included 352 patients who experienced acute major bleeding within 18 hours of receiving apixaban, rivaroxaban, edoxaban, or enoxaparin. The Xa factor inhibitors are used to manage thrombotic risk but can cause potentially deadly bleeding events. Each participant in the ANNEXA-4 trial received a bolus of andexanet alfa—a modified recombinant inactive form of human factor Xa developed as a reversal agent—followed by a 2-hour infusion. Andexanet treatment significantly reduced median anti–factor Xa activity in this patient population. In addition, the intervention was associated with excellent or good hemostatic efficacy at 12 hours in 82% of the patients who could be assessed after 30 days. Rapid reversal of factor Xa inhibition, the researchers conclude, accelerates hemostatic control and should improve clinical outcomes. (Click for more...) In a measles outbreak, demand for vaccine spikes 2/11/2019 11:38:29 AM In a measles outbreak, demand for vaccine spikes Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 The measles outbreak in Washington is prompting many people in the state and nearby Oregon to get vaccinated. According to the Washington state health department, more than 3,000 people were immunized against measles last month—up from about 530 in January 2018. In Portland, OR, a nurse practitioner who helps run the Health Center at Roosevelt High School reports that a number of teenagers have come to her to catch up on their immunizations because their parents do not believe in them. In Oregon, state law permits children aged 15 years or older to consent to health care, meaning they can receive vaccinations without parental consent. The outbreak—which has infected more than 50 people, mostly children, already - is still evolving, officials say, and it is not expected to end very soon. The state legislatures in both Washington and Oregon are considering changes to laws that allow children to attend school unvaccinated because of personal beliefs. (Click for more...) Ending the HIV epidemic 2/11/2019 11:38:29 AM Ending the HIV epidemic Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 HHS has proposed a new strategic initiative to combat HIV, which continues to pose a global public health threat despite major scientific advances, write NIAID director Anthony Fauci, CDC director Robert Redfield, and others in an editorial. The four major components of the plan call for early diagnosis, rapid and effective treatment, a focus on prevention, and rapid detection of and response to infection hotspots in order to clip new transmissions. Decades of research collectively suggest that widening access to antiretroviral therapy to all HIV patients and preexposure prophylaxis (PrEP) to anyone at high risk of infection can finally bring this pandemic under control in the United States. The first phase of attack targets the initiative to geographic and demographic populations where new HIV cases are most prevalent: 19 states and the District of Columbia, plus Puerto Rico. HHS does not intend to take on this campaign alone, but will work with multiple other agencies, including CDC, NIH, and the Health Resources and Services Administration. The cooperation of city, county, and state public health departments, clinics and health care facilities, clinicians, and community and faith-based groups, among other stakeholders, will also be invaluable. Additionally, more federal dollars could bolster this work if President Trump's budget this year reflects his administration's goal of ending the HIV pandemic within 10 years. If seen through, HHS believes incident HIV infections in this country have the potential to plummet by 75% within 5 years under its plan and by 90% within 10 years, the authors conclude. (Click for more...) CDC: Influenza activity hits highest level this season 2/11/2019 11:38:27 AM CDC: Influenza activity hits highest level this season Sun, 02/10/2019 - 19:00 cbaker_admin Mon, 02/11/2019 - 11:38 CDC reported Friday that the percentage of people going to the doctor for influenza-like illness (ILI) last week rose from 3.8% to 4.3%, the highest level so far this season. CDC noted, however, that the ILI level is still far lower than the 7.5% peak recorded last year. All 10 U.S. geographic regions reported ILI levels at or above region-specific baselines, CDC said, and all severity indicators increased in the past week as well. Influenza activity is expected to remain elevated for several weeks. In all, 24 states and New York City reported high ILI, up from 23 states in the previous week, and 47 states have reported widespread geographic influenza activity. The hospitalization rate last week for influenza was 20.1 per 100,000 population, compared with 15.3 in the previous week, primarily among older adults and children younger than age 5 years. CDC noted that there were 4 more pediatric deaths from influenza last week, for a total of 28 this season. The dominant strain is influenza A, accounting for 98.3% of all lab specimens tested. (Click for more...) Cardiovascular risks of fertility treatments 2/11/2019 11:24:38 AM Primary Category: EndocrinologyKey point: Use of fertility treatments did not appear to be associated with an increased risk of cardiovascular (CV) events, but the limitations of the available data are inadequate to draw any conclusions about the long-term CV safety of these therapies, according to results of a systematic review and meta-analysis published in the Journal of the American College of Cardiology. Finer points: Use of fertility treatments has risen in recent years, but these therapies are not without risks. Some data suggest that fertility treatments may adversely affect CV disease, while other data have not shown an increased risk. A systematic review and meta-analysis of published case-control, cohort, and randomized clinical trials from 1946 to January 2017 assessed the use of fertility treatments and incident CV risk factors (e.g., hypertension, diabetes), and overt CV outcomes (e.g., coronary ischemia, CV death, CV hospitalizations, heart failure, myocardial infarction, cerebrovascular ischemia, stroke, transient ischemic attack, and venous thromboembolism), with a minimum follow-up of at least 1 year. Six observational studies were included, with 41,190 women exposed to fertility treatment and 1,441,392 who were not. Fertility treatments varied across the studies and included intrauterine insemination (IUI), in vitro fertilization (IVF), ovulation induction, and controlled ovarian stimulation with gonadotropins. The mean age at delivery ranged from 28.5 years to 34 years, and the median duration of follow-up was 9.8 years (range 1 to >20 y). Four studies reported CV events, and results of the pooled analysis of these trials showed that use of fertility treatment in these studies was not associated with an increased risk of cardiac events (hazard ratio [HR] 0.91 [95% CI 0.67–1.25]). Two studies reported on the risk of stroke, and the pooled analysis of these studies suggested a nonsignificant increase in the risk of stroke (1.25, 0.96–1.63). Also, two studies reported on the risk of diabetes and found no increased risk (0.93, 0.87–1.001). Because of the heterogeneity, the results were not pooled for hypertension or venous thromboembolism. What you need to know: The current analysis suggests that fertility treatments may not be associated with an increased risk of adverse CV events, but inclusion of a limited number of studies, primarily observational, and the heterogeneity among the studies make it difficult to establish definitive conclusions. The authors discussed how fertility treatments may adversely affect CV outcomes by contributing to enduring changes to the vasculature following the intense, repeated, high-dose exposure to reproductive hormones that occurs during treatment. The authors concluded that large-scale, prospective studies are needed to clarify the safety of fertility therapy and the impact of reproductive factors on CV risk. They acknowledge several limitations with their research, including the potential for treatment effects reported in observational trials to be confounded by indication (infertility may confer an increased CV risk), varied exposure durations among studies without enough detail on the type or dose of fertility therapy used, and inadequate long-term follow-up to find a meaningful difference in CV outcomes among young women. An accompanying editorial commented on the current analysis and wrote, “What we can take away as the most important point is that existing data are insufficient to draw any conclusions regarding the long-term CV safety of fertility therapy.” They propose that increased CV risk in the setting of fertility therapy may involve excess estrogen exposure in ovarian hyperstimulation which can lead to severe multiorgan dysfunction and massive fluid shifts in the body, altered vascular function, disorders in the renin-angiotensin-aldosterone axis, and endothelial dysfunction. They concluded, “The true utility of the present study … is in its illustration of important knowledge gaps in our current evidence and the critical need for sex-specific studies assessing nontraditional risk factors, such as adverse pregnancy outcomes and fertility history, and long-term CV risk.” What your patients need to know: Inform women considering or currently using fertility treatments that results of a new analysis suggest these treatments do not appear to increase the risk of adverse CV events, but the evidence is limited and therefore inconclusive. Encourage them to discuss the potential risks associated with fertility treatments with their provider so they can make an educated decision about the risk–benefit profile of these treatment modalities. Sources: Dayan N, et al. Cardiovascular risk following fertility therapy: systematic review and meta-analysis. J Am Coll Cardiol. 2017;70(10):1203–13. Pepine CJ, et al. Fertility therapy and long-term cardiovascular risk: raising more questions than answers? J Am Coll Cardiol. 2017;70(10):1214–5. Primary Section Advisor: Frank PucinoSecondary Category: Cardiology (Click for more...) New data support apixaban over rivaroxaban for newly diagnosed VTE 2/11/2019 10:58:19 AM Primary Category: Focus on Anticoagulation CareKey point: Use of apixaban (Eliquis—Bristol–Myers Squibb, Pfizer) appears to be more effective than rivaroxaban (Xarelto—Janssen) for prevention of recurrent venous thromboembolism (VTE) with a decreased risk of major bleeding events, according to results of a retrospective, observational study published in The Lancet Haematology. Finer points: Use of direct oral anticoagulants (DOACs) for management of VTEs has increased in recent years compared with traditional warfarin therapy because of their conventional dosing and lack of routine monitoring. However, there are currently no head-to-head comparisons to determine which DOAC may be preferred for patients with VTE. Dawwas and colleagues conducted a retrospective cohort analysis of data from the Truven Health MarketScan commercial and Medicare Supplement claims database from January 1, 2014, to December 31, 2016, to identify adult patients with newly diagnosed VTE treated with either apixaban or rivaroxaban for the first time. Participants were propensity-score matched in a 1:4 ratio for apixaban (n = 3,091) and rivaroxaban (n = 12,163) on the basis of a variety of covariates, such as patient demographics, comorbidities, previous use of medications, and a measure of health care use. Participants were a mean age of 61.6 years in the apixaban group and 59.9 years in the rivaroxaban group. There was almost an equal 50/50 split of males and females in both groups, and the mean follow-up was 99 days for both treatments. The results of the primary efficacy outcome, which was the [crude] incidence of recurrent VTE, was three per 100 person-years in the apixaban group compared with seven per 100 person-years in the rivaroxaban group. Also, the results of the primary safety outcome, the [crude] incidence of major bleeding events, was three per 100 person-years in the apixaban group compared with six per 100 person-years in the rivaroxaban group. The multivariate Cox regression model showed that use of apixaban compared with rivaroxaban was associated with a decreased risk of recurrent VTE (HR 0.37 [95% CI 0.24–0.55]) and major bleeding events (0.54, 0.37–0.82). Use of apixaban was also associated with a lower risk of minor bleeding (0.57, 0.48–0.67). What you need to know: Researchers of the current study acknowledged that this is one of the first analyses to conclude that apixaban may be preferred to rivaroxaban for the management of patients with VTE. They commented on two network meta-analyses which did not find a difference between apixaban and rivaroxaban for the prevention of recurrent VTE or death caused by VTE but noted that these analyses might have been underpowered to detect treatment differences. They wrote that the differences observed in their study might be partially explained by the pharmacokinetic profile of the two medications, with safety benefits seen with a lower peak-to-trough ratio with twice-daily dosing of apixaban compared with once-daily dosing of rivaroxaban. They concluded that additional studies are needed to confirm these findings. In an accompanying comment, the authors wrote, “Specific DOAC selection in routine clinical practice is mostly based on expert opinion, individual characteristics, and patient preferences, rather than solid evidence.” They noted that the current data suggest apixaban may be the optimal choice; “however, results of observational studies need to be interpreted with caution, and the question of whether a specific DOAC is more effective than others, at least in particular settings, is not fully resolved.” What your patients need to know: Inform patients with a VTE that results of a new analysis suggest that apixaban may be slightly more effective and safer than rivaroxaban. Educate them on signs of VTE (e.g., pain/redness in the calf, chest pain, shortness of breath) and bleeding symptoms (e.g., blood in the urine/stool), and direct them to seek immediate medical care if any of these occur. Also, encourage patients to talk to their prescriber about their best treatment option, based on patient characteristics and preferences. Sources: Dawwas GK, et al. Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis. Lancet Haematol. 2019;6(1):e20–8. Frere C, et al. The best direct-acting oral anticoagulant for treatment of venous thromboembolism. Lancet Haematol. 2019;6(1):e4–5. Primary Section Advisor: Sarah Ray (Click for more...) CDC’s ACIP releases 2019 adult and child vaccine schedules 2/11/2019 10:04:05 AM CDC’s ACIP releases 2019 adult and child vaccine schedules Mon, 02/11/2019 - 10:18 caldridgeyoung… Mon, 02/11/2019 - 10:04 Changes to the adult schedule include recommendations on use of the live attenuated influenza vaccine. In addition, ACIP recommends the new single-antigen recombinant hepatitis B vaccine (Heplisav-B—Dynavax) for prevention of hepatitis B virus infection. For the child/adolescent schedule, pharmacists should know that the I.N. live attenuated influenza vaccine ([LAIV] FluMist—AstraZeneca) has returned as an option. There’s also information related to hepatitis B for this patient group. (Click for more...) Music at the Pylons on Feb.14 2/11/2019 12:00:00 AM All are invited to join in musical recitals from WVU Health Sciences students and employees on Feb. 14, at noon in the Pylons Lobby. (Click for more...) Abciximab Injection 2/10/2019 7:00:00 PM Drug: Abciximab Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Acetazolamide Injection 2/10/2019 7:00:00 PM Drug: Acetazolamide Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Albuterol Inhalation Solution 2/10/2019 7:00:00 PM Drug: Albuterol Inhalation Solution, Revision Date: Mon, 11 Feb 2019 (Click for more...) Aminophylline Injection 2/10/2019 7:00:00 PM Drug: Aminophylline Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection 2/10/2019 7:00:00 PM Drug: Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Diazepam Injection 2/10/2019 7:00:00 PM Drug: Diazepam Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Furosemide Tablets 2/10/2019 7:00:00 PM Drug: Furosemide Tablets, Revision Date: Mon, 11 Feb 2019 (Click for more...) Heparin Sodium Premixed Bags 2/10/2019 7:00:00 PM Drug: Heparin Sodium Premixed Bags, Revision Date: Mon, 11 Feb 2019 (Click for more...) Hydralazine injection 2/10/2019 7:00:00 PM Drug: Hydralazine injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Immune Globulin, Subcutaneous (Human) 2/10/2019 7:00:00 PM Drug: Immune Globulin, Subcutaneous (Human), Revision Date: Mon, 11 Feb 2019 (Click for more...) Indomethacin Capsules 2/10/2019 7:00:00 PM Drug: Indomethacin Capsules, Revision Date: Mon, 11 Feb 2019 (Click for more...) Letermovir Injection 2/10/2019 7:00:00 PM Drug: Letermovir Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Levetiracetam Injection 2/10/2019 7:00:00 PM Drug: Levetiracetam Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Losartan and Hydrochlorothiazide Tablets 2/10/2019 7:00:00 PM Drug: Losartan and Hydrochlorothiazide Tablets, Revision Date: Mon, 11 Feb 2019 (Click for more...) Norepinephrine Bitartrate Injection 2/10/2019 7:00:00 PM Drug: Norepinephrine Bitartrate Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) Thrombin Topical Solution (Bovine) 2/10/2019 7:00:00 PM Drug: Thrombin Topical Solution (Bovine), Revision Date: Mon, 11 Feb 2019 (Click for more...) Valganciclovir HCl Oral Powder for Solution 2/10/2019 7:00:00 PM Drug: Valganciclovir HCl Oral Powder for Solution, Revision Date: Mon, 11 Feb 2019 (Click for more...) Vecuronium Bromide Injection 2/10/2019 7:00:00 PM Drug: Vecuronium Bromide Injection, Revision Date: Mon, 11 Feb 2019 (Click for more...) FDA pursues order barring specific retailers from selling tobacco products 2/8/2019 3:05:01 PM FDA pursues order barring specific retailers from selling tobacco products Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 FDA launched on Thursday enforcement action against two Walgreens and Circle K locations for multiple violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors. FDA is seeking No-Tobacco-Sale Orders (NTSO) against a Walgreens store in Miami and a Circle K store in Charleston, SC, aiming to prohibit the two stores from selling tobacco products for 30 days. According to the agency, Walgreens is the top violator among pharmacies that sell tobacco products, with nearly a quarter of the stores inspected having illegally sold tobacco products to underage individuals. "I will be writing the corporate management of Walgreens and requesting a meeting with them to discuss whether there is a corporate-wide issue related to their stores' non-compliance and put them on notice that the FDA is considering additional enforcement avenues to address their record of violative tobacco sales to youth," said FDA Commissioner Scott Gottlieb, MD. He added, "I'm also deeply disturbed that a single pharmacy chain racked up almost 1,800 violations for selling tobacco products to minors across the country. I have particular concerns about whether the pharmacy setting is influencing consumer and retailer perceptions around tobacco products in a way that's contributing to these troubling findings." The NTSO action against the Miami Walgreens location is the first such action taken against a Walgreens store. The NTSO action against Circle K is not its first, but it is the first time FDA has initiated an NTSO complaint for the sale of deemed products (cigars) to minors. (Click for more...) A global wave of measles cases fed by conspiracies and misinformation has health officials worried 2/8/2019 3:05:01 PM A global wave of measles cases fed by conspiracies and misinformation has health officials worried Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 The World Health Organization (WHO) released a report estimating that there were 6.7 million cases of measles in 2017, with the vast majority occurring in poorer countries. Between 2016 and 2017, reported cases surged by 30%. There were 15 times more measles cases in Europe last year than in 2016 and new outbreaks were also recorded in South America and parts of Asia. "The picture for 2018 makes it clear that the current pace of progress in raising immunization rates will be insufficient to stop measles circulation," said Zsuzsanna Jakab, a Europe-focused senior official with the WHO. The Western Pacific region—which includes China, Australia, Pacific islands and large parts of Southeast Asia—is the only part of the world where vaccination rates against measles are on the rise, bucking the global trend. In many of those places, prior measles outbreaks have sharpened parents' minds to the risks of the virus, and have limited resistance against vaccinations. But in the wealthier countries where warnings of the virus are more likely to trigger a shrug of parents' shoulders than real concern, the virus is returning or becoming more common once again. One reason for the global resurgence of measles could be a complacency on the part of parents, who may consider measles to be among the least likely possible illnesses to affect their kids. In some places, complacency over vaccinations has been accompanied by outright rejection of the scientific evidence on measles vaccines. (Click for more...) Omadacycline for CABP 2/8/2019 3:05:01 PM Omadacycline for CABP Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 Omadacycline achieves high concentrations in pulmonary tissues and is active against common pathogens that cause community-acquired bacterial pneumonia, making it a potential therapeutic option in this setting. To investigate, researchers designed the OPTIC randomized trial to compare the antibiotic agent's efficacy with that of moxifloxacin in adults. A total of 386 adults with community-acquired bacterial pneumonia were assigned to omadacycline, while 388 were allocated to moxifloxacin. The study drugs were administered intravenously for the first 3 days, with switchover to oral administration permitted after that, for a total treatment period of 1–2 weeks. The early clinical response rate with omadacycline was 81.1%, meaning that patients experienced improvement in at least two of four symptoms—cough, sputum production, pleuritic chest pain, and dyspnea—with no exacerbation of symptoms at 72–120 hours. Because the rate fell within 10 percentage points of the 82.7% clinical response rate for moxifloxacin, noninferiority was established. (Click for more...) Omadacycline for acute bacterial skin and skin-structure infections 2/8/2019 3:05:01 PM Omadacycline for acute bacterial skin and skin-structure infections Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 The antibiotic agent omadacycline has demonstrated action against pathogens implicated in the development of acute bacterial skin and skin-structure infections. To gauge its efficacy in this setting, the OASIS-1 investigators recruited adult patients and randomized them to 7–14 days of either omadacycline or linezolid. All patients started with I.V. delivery of the drugs but were allowed to change to oral administration after 3 days. The primary outcome was survival with at least 20% shrinkage in lesion size and without rescue antibacterial therapy at 48–72 hours. This early clinical response occurred in 84.8% of the 316 participants in the omadacycline group and 85.5% of the 311 participants in the linezolid group. With a prespecified noninferiority threshold of 10 percentage points, omadacycline was deemed noninferior to linezolid for the treatment of acute bacterial skin and skin-structure infections. It also met the noninferiority threshold for investigator-assessed clinical response during the post-treatment evaluation. Meanwhile, the safety profile for omadacycline was comparable with that of linezolid. (Click for more...) FDA approves cheaper onabotulinumtoxinA rival to treat frown lines 2/8/2019 3:05:01 PM FDA approves cheaper onabotulinumtoxinA rival to treat frown lines Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 FDA has approved prabotulinumtoxinA-xvfs (Jeuveau—Evolus) to treat forehead wrinkles. The injection is set to rival onabotulinumtoxinA (Botox—Allergan). The approval comes 8 months after FDA declined to approve the drug, citing deficiencies related to the chemistry and manufacturing of the product. Evolus expects prabotulinumtoxinA-xvfs to be priced between 20% and 25% lower than onabotulinumtoxinA, and it will likely be available beginning this spring. (Click for more...) J&J becomes first drugmaker to add prices to television ads 2/8/2019 3:05:01 PM J&J becomes first drugmaker to add prices to television ads Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 Johnson & Johnson will start adding the price of its medicines to television commercials by next month, becoming the first drugmaker to take that step. J&J will include both the list price of a product as well as potential out-of-pocket costs that patients will pay. HHS Secretary Alex Azar praised the move. Last May, Azar's office released a blueprint for reducing the cost of drug prices, which included a proposal to require disclosure of list prices in television advertisements for drugs. "We commend Johnson & Johnson for recognizing the value of informing consumers about list prices and for doing so voluntarily. We call on other manufacturers to follow their lead," Azar said in a statement. (Click for more...) HHS Sec. Azar visits community pharmacists 2/8/2019 3:05:01 PM HHS Sec. Azar visits community pharmacists Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 HHS Secretary Alex Azar visited this week Chateau Drugs and Gifts in Metairie, LA. The trip, made to help highlight the Trump administration's efforts to reduce prescription drug costs, was Azar's second official visit to a community pharmacy in recent months. Topics discussed during the visit included the 2018 laws to ban "gag clauses," the recently proposed policies to end retroactive pharmacy direct and indirect remuneration fees, and the proposal to exclude from the discount safe harbor the rebates paid by manufacturers to plan sponsors under Medicare Part D and Medicaid managed care organizations. "As it is, there are such challenges with PBMs and reimbursement that I as a community pharmacy owner often make more on votive candles than on some prescriptions," said Chateau pharmacy's Diane Milano, a registered pharmacist. "We are so grateful that the administration is working hard to change this system for small business pharmacy owners and for the patients we are dedicated to serving." B. Douglas Hoey, CEO of the National Community Pharmacists Association, thanked "Secretary Azar for continuing to visit community pharmacies and providing opportunities for America's most accessible health care providers to offer their perspectives on how they can serve their patients and help bring down costs." (Click for more...) A Chicago pharma company raised the price of its skin gel to $7,968. Now it is bankrupt. 2/8/2019 3:05:01 PM A Chicago pharma company raised the price of its skin gel to $7,968. Now it is bankrupt. Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 Novum Pharma has filed for Chapter 11 in U.S. Bankruptcy Court in Delaware. The Chicago pharmaceutical company gained notoriety in 2016, after raising the wholesale price of its hydrocortisone acetate/iodoquinol/aloe polysaccharides (Alcortin A) skin gel to $7,968 from $226, according to a U.S. Senate subcommittee report. The company defended its pricing at the time, saying the quoted prices for Alcortin A, Aloquin, and Novacort were inaccurate and that most patients with private insurance paid no co-pay for it while those without insurance never had to pay more than $35. According to the filing, Novum hopes to sell its assets and continue operating through the bankruptcy process. Novum Chief Restructuring Officer Thomas O'Donoghue attributed the company's bankruptcy to manufacturing issues, a dispute with a wholesaler and major pharmacy chain, and unauthorized generic alternatives being introduced into the market. He said that PBMs have refused to include the company's drugs on prescription formularies, which means insurance plans often do not cover the medications. The company increased its prices to deal with that lack of insurance coverage. Although the price increases were "necessary to support patient access commitments and ensure a minimum level of profitability for the business," they only exacerbated the problem, he said. (Click for more...) Top U.S. insurer to cover Amgen, Eli Lilly migraine drugs, exclude Teva 2/8/2019 3:05:01 PM Top U.S. insurer to cover Amgen, Eli Lilly migraine drugs, exclude Teva Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 New migraine drugs from Amgen and Eli Lilly have been included as preferred treatments on OptumRx's lists of covered drugs. According to an OptumRx client note, Teva Pharmaceuticals' migraine drug is excluded on one list, while patients can pay more for it in some cases on a second. The OptumRx decision became effective on February 1. OptumRx's formulary places Teva's drug in a lower access level that typically requires a higher out-of-pocket cost. The three treatments, approved by the FDA last year, belong to a class of drugs called CGRP inhibitors. The decisions highlight how more PBMs are selecting a subset of treatments for their coverage list when there are several treatments deemed equivalent. A Teva spokeswoman says the company is committed to increasing access to its treatment irrespective of formulary inclusions and is still offering discounts that allow patients, including uninsured ones, to pay nothing in some cases. (Click for more...) FDA to adopt modern technologies for improving the security of the drug supply chain 2/8/2019 3:05:01 PM FDA to adopt modern technologies for improving the security of the drug supply chain Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 FDA on Thursday launched a new pilot project in which manufacturers, repackagers, and other stakeholders representing the drug supply chain can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the United States. Eligible entities may apply to participate in the program. The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act (DSCSA). The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain. The DSCSA pilot project program is intended to help identify and evaluate the most efficient processes to comply with and apply drug supply chain security requirements. (Click for more...) Dems unveil bill for Medicare to negotiate drug prices 2/8/2019 3:05:01 PM Dems unveil bill for Medicare to negotiate drug prices Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 A new bill would allow Medicare to negotiate drug prices. The measure was announced Thursday by Sen. Sherrod Brown (D-OH) and Rep. Lloyd Doggett (D-TX). "What we're really doing today is just calling on President Trump to listen to candidate Trump," said Doggett, who is chairman of the House Ways and Means Health Subcommittee. He noted that Trump backed the idea of Medicare negotiating drug prices in 2016 before backing off from such a plan. Although there are long odds that the bill could get through the GOP-controlled Senate, Brown indicated he hoped a strong House vote would "put the pressure on [Senate Majority Leader] Mitch McConnell." Others indicated that if the president came out in full support of the measure, it would pressure Senate Republicans as well. (Click for more...) Chain pays $1M to settle poor pharmacy record-keeping claims 2/8/2019 3:05:01 PM Chain pays $1M to settle poor pharmacy record-keeping claims Thu, 02/07/2019 - 19:00 cbaker_admin Fri, 02/08/2019 - 15:05 FF Acquisition Inc., which owns the Farm Fresh grocery stores in Virginia, has agreed to pay $1 million to settle claims that its pharmacies failed to keep proper records of controlled substances. The chain operates more than 30 pharmacies in eastern Virginia. According to federal officials, Farm Fresh did not record dates and quantities of controlled substances it shipped and received, nor did it report thefts on a timely basis. The payment was announced Tuesday by the U.S. Attorney's Office for the Eastern District of Virginia. (Click for more...) To reap benefits of fish oil, formulation and dose might matter 2/8/2019 10:28:16 AM To reap benefits of fish oil, formulation and dose might matter Fri, 02/08/2019 - 10:53 caldridgeyoung… Fri, 02/08/2019 - 10:28 Deepak L. Bhatt and colleagues performed a randomized controlled trial REDUCE-ITwith patients taking icosapent ethyl (Vascepa—Amarin), a substance derived from a component of fish oil approved by FDA in 2012 to treat patients with high triglyceride levels. (Click for more...) 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes 2/7/2019 7:00:00 PM Drug: 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes, Revision Date: Fri, 08 Feb 2019 (Click for more...) Dexamethasone Sodium Phosphate Injection 2/7/2019 7:00:00 PM Drug: Dexamethasone Sodium Phosphate Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Famotidine Injection 2/7/2019 7:00:00 PM Drug: Famotidine Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Fluconazole Injection 2/7/2019 7:00:00 PM Drug: Fluconazole Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Folic Acid Injection 2/7/2019 7:00:00 PM Drug: Folic Acid Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Heparin Injection 2/7/2019 7:00:00 PM Drug: Heparin Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Iron Dextran Injection 2/7/2019 7:00:00 PM Drug: Iron Dextran Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Ketorolac Injection 2/7/2019 7:00:00 PM Drug: Ketorolac Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Latanoprost Ophthalmic Solution 2/7/2019 7:00:00 PM Drug: Latanoprost Ophthalmic Solution, Revision Date: Fri, 08 Feb 2019 (Click for more...) Lorazepam Tablets 2/7/2019 7:00:00 PM Drug: Lorazepam Tablets, Revision Date: Fri, 08 Feb 2019 (Click for more...) Magnesium Sulfate Injection 2/7/2019 7:00:00 PM Drug: Magnesium Sulfate Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Melphalan Injection 2/7/2019 7:00:00 PM Drug: Melphalan Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Methocarbamol Tablets 2/7/2019 7:00:00 PM Drug: Methocarbamol Tablets, Revision Date: Fri, 08 Feb 2019 (Click for more...) Metoclopramide Injection 2/7/2019 7:00:00 PM Drug: Metoclopramide Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Mineral Oil and Petrolatum Ophthalmic Ointment 2/7/2019 7:00:00 PM Drug: Mineral Oil and Petrolatum Ophthalmic Ointment, Revision Date: Fri, 08 Feb 2019 (Click for more...) Multiple Vitamins for Infusion 2/7/2019 7:00:00 PM Drug: Multiple Vitamins for Infusion, Revision Date: Fri, 08 Feb 2019 (Click for more...) Ondansetron Hydrochloride Injection 2/7/2019 7:00:00 PM Drug: Ondansetron Hydrochloride Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Phenytoin Sodium Injection 2/7/2019 7:00:00 PM Drug: Phenytoin Sodium Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Progesterone Injection 2/7/2019 7:00:00 PM Drug: Progesterone Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Sodium Acetate Injection 2/7/2019 7:00:00 PM Drug: Sodium Acetate Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Temazepam Capsules 2/7/2019 7:00:00 PM Drug: Temazepam Capsules, Revision Date: Fri, 08 Feb 2019 (Click for more...) Thiamine Injection 2/7/2019 7:00:00 PM Drug: Thiamine Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) Vancomycin Hydrochloride Injection 2/7/2019 7:00:00 PM Drug: Vancomycin Hydrochloride Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) C1-Esterase Inhibitor (Human) Injection 2/7/2019 7:00:00 PM Drug: C1-Esterase Inhibitor (Human) Injection, Revision Date: Fri, 08 Feb 2019 (Click for more...) FDA approves first drug therapy for adults with rare blood clotting disorder 2/7/2019 9:03:29 AM Generic Name: Caplacizumab-yhdpTrade Name: CabliviCompany: AblynxNotes: FDA approved caplacizumab-yhdp injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body. These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death. Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections or after having surgery, bone marrow transplantation, or chemotherapy. Common adverse effects reported by patients in clinical trials were bleeding of the nose or gums and headache. The prescribing information for caplacizumab-yhdp includes a warning to advise health care providers and patients about the risk of severe bleeding. Health care providers are advised to monitor patients closely for bleeding when administering the drug to patients who currently take anticoagulants. Medication Monitor Categories: New Drug Approvals (Click for more...) Geriatrics Lunchtime Learning February 27, 2019 2/7/2019 12:00:00 AM Geriatrics Lunchtime Learning February 27, 2019 (Click for more...) Calcium Chloride Injection 2/6/2019 7:00:00 PM Drug: Calcium Chloride Injection, Revision Date: Thu, 07 Feb 2019 (Click for more...) Ethiodized Oil 2/6/2019 7:00:00 PM Drug: Ethiodized Oil, Revision Date: Thu, 07 Feb 2019 (Click for more...) Immune Globulin, Intravenous or Subcutaneous (Human) 2/6/2019 7:00:00 PM Drug: Immune Globulin, Intravenous or Subcutaneous (Human), Revision Date: Thu, 07 Feb 2019 (Click for more...) Isocarboxazid Tablets 2/6/2019 7:00:00 PM Drug: Isocarboxazid Tablets, Revision Date: Thu, 07 Feb 2019 (Click for more...) Methotrexate Injection 2/6/2019 7:00:00 PM Drug: Methotrexate Injection, Revision Date: Thu, 07 Feb 2019 (Click for more...) Midodrine Tablets 2/6/2019 7:00:00 PM Drug: Midodrine Tablets, Revision Date: Thu, 07 Feb 2019 (Click for more...) Nystatin Oral Suspension 2/6/2019 7:00:00 PM Drug: Nystatin Oral Suspension, Revision Date: Thu, 07 Feb 2019 (Click for more...) Sincalide Injection 2/6/2019 7:00:00 PM Drug: Sincalide Injection, Revision Date: Thu, 07 Feb 2019 (Click for more...) Spironolactone Tablets 2/6/2019 7:00:00 PM Drug: Spironolactone Tablets, Revision Date: Thu, 07 Feb 2019 (Click for more...) Thrombin Topical Powder (Recombinant) 2/6/2019 7:00:00 PM Drug: Thrombin Topical Powder (Recombinant), Revision Date: Thu, 07 Feb 2019 (Click for more...) Valsartan and Hydrochlorothiazide Tablets 2/6/2019 7:00:00 PM Drug: Valsartan and Hydrochlorothiazide Tablets, Revision Date: Thu, 07 Feb 2019 (Click for more...) Valsartan Tablets 2/6/2019 7:00:00 PM Drug: Valsartan Tablets, Revision Date: Thu, 07 Feb 2019 (Click for more...) Meropenem Injection 2/5/2019 7:00:00 PM Drug: Meropenem Injection, Revision Date: Wed, 06 Feb 2019 (Click for more...) Pentamidine Isethionate 2/5/2019 7:00:00 PM Drug: Pentamidine Isethionate, Revision Date: Wed, 06 Feb 2019 (Click for more...) Sodium Polystyrene Sulfonate Oral or Rectal Suspension 2/5/2019 7:00:00 PM Drug: Sodium Polystyrene Sulfonate Oral or Rectal Suspension, Revision Date: Wed, 06 Feb 2019 (Click for more...) Sodium Polystyrene Sulfonate Powder 2/5/2019 7:00:00 PM Drug: Sodium Polystyrene Sulfonate Powder, Revision Date: Wed, 06 Feb 2019 (Click for more...) FDA approves cabozantinib tablets for previously treated hepatocellular carcinoma 2/5/2019 4:23:48 PM Generic Name: CabozantinibTrade Name: CabometyxCompany: ExelixisNotes: Exelixis announced FDA approval of a new indication for cabozantinib in patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval was based on results from the CELESTIAL Phase III pivotal trial that enrolled patients with advanced HCC who received prior sorafenib. Cabozantinib demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo. The tablets come in 20-, 40-, and 60-mg dosage strengths. The recommended dose is 60 mg orally, once daily. The drug should be administered at least 1 hour before or at least 2 hours after eating. Tablets should not be substituted with cabozantinib capsules. The most common adverse events are palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase, fatigue, and diarrhea. Serious adverse effects include hemorrhage, perforation of the stomach or intestinal or fistula; and blood clots, stroke, heart attack, and chest pain. Medication Monitor Categories: Supplemental Approvals (Click for more...) New product approved for 'frown lines' 2/5/2019 4:06:37 PM Generic Name: PrabotulinumtoxinA-xvfsTrade Name: JeuveauCompany: EvolusNotes: Evolus announced FDA approval of prabotulinumtoxinA-xvfs, an acetylcholine release inhibitor and a neuromuscular blocking agent that temporarily improves the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) associated with corrugator and/or procerus muscle activity in adults. Approval was supported by clinical data from two Phase III randomized, multicenter, double-blind, placebo-controlled clinical trials. Both trials met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at day 30. Dosage is 0.1 mL (four units) by I.M. injection into each of five sites, for a total dose of 20 units. The product may cause rare but serious adverse effects that can be life-threatening, including problems swallowing, speaking, or breathing due to weakening of associated muscles and spread of toxin effects. The most common adverse effects include headache, eyelid drooping, upper respiratory tract infection, and increased white blood cell count. The product is expected to be available in spring 2019. Medication Monitor Categories: New Drug Approvals (Click for more...) Treatment outcomes improved in nonmetastatic pancreatic cancer 2/5/2019 12:01:01 PM Primary Category: OncologyKey point: In patients with nonmetastatic resected pancreatic adenocarcinoma, adjuvant chemotherapy with a modified FOLFIRINOX regimen led to significantly longer survival than treatment with gemcitabine (Gemzar—Lilly) but with a higher incidence of adverse effects, according to a study published in the New England Journal of Medicine. Finer points: Pancreatic adenocarcinoma holds the lowest 5-year survival rate among any solid tumor and is projected to be the second-leading cause of death from cancer in the United States. Currently, surgery remains the only cure, but extensive local involvement and early distant spread disqualify all but 20% of patients for resection. With limited options available for adjuvant chemotherapy, most patients with pancreatic cancer who undergo surgical resection will survive less than 3 years. Conroy and colleagues published the results of PRODIGE-24, an international, randomized, Phase III trial of a modified FOLFIRINOX regimen consisting of leucovorin, fluorouracil, irinotecan, and oxaliplatin every 2 weeks compared with gemcitabine on days 1, 8, and 15 every 4 weeks for 6 months. The study included 493 patients aged 79 or younger with resected pancreatic ductal adenocarcinoma who had undergone an R0 (no residual tumor) or R1 (microscopic residual tumor) resection 3 to 12 weeks before randomization and who had a CA 19-9 level of 180 U per mL or less. The primary endpoint was disease-free survival. The median disease-free survival was 21.6 months in the modified-FOLFIRINOX arm versus 12.8 months in the gemcitabine arm (stratified hazard ratio [HR] for a cancer-related event, second cancer, or death, 0.58 [95% CI 0.46–0.73]) at a median follow-up of 33.6 months. Other endpoints for the modified-FOLFIRINOX and the gemcitabine groups, respectively, included disease-free survival rates at 3 years of 39.7% versus 21.4%, median overall survival of 54.4 months versus 35 months, and overall survival rates at 3 years of 63.4% versus 48.6%. In the modified-FOLIRINOX arm, 75.9% of the patients and 52.9% of those in the gemcitabine arm experienced adverse events of grade 3 or 4. Adverse effects associated with modified-FOLFIRINOX therapy included diarrhea, increased gamma-glutamyltransferase levels, paresthesia, fatigue, peripheral neuropathy, nausea, vomiting, abdominal pain, and mucositis. These adverse effects were reversed, except for oxaliplatin-induced peripheral neuropathy, which persisted at 3 years in two patients. Of note, one patient in the gemcitabine group died from treatment-related interstitial pneumonitis. What you need to know: The advantage in disease-free survival seen with this modified-FOLFIRINOX regimen was encouraging and was further validated against selection bias, as the results for gemcitabine match those in previous literature. The median overall survival of 54.4 months seen in the experimental group of the PRODIGE-24 trial was a breakthrough for patients with this disease. Adjuvant modified FOLFIRINOX therapy may change the standard of care for pancreatic adenocarcinoma. An accompanying editorial noted that this evidence might represent the most significant impact in treatment outcomes for pancreatic adenocarcinoma since 1985. As expected, the safety profile of the modified FOLFIRINOX regimen was less favorable than with gemcitabine but appeared to be manageable. Neutropenia was reduced by removing the bolus fluorouracil and reducing the irinotecan dose. The decreased irinotecan dose also significantly reduced the incidence of diarrhea. What your patients need to know: Inform patients with pancreatic adenocarcinoma who qualify for an R1 or R0 resection that a promising treatment has been identified that significantly improves their survival. Educate them on the potential benefits and risks associated with the modified FOLFIRINOX regimen. Three-fourths of patients receiving this regimen experience grade 3 or 4 adverse events. Explain that grade 3 indicates a severe or medically significant reaction that is not immediately life-threatening but may require hospitalization, prolong hospitalization, or be disabling. A grade 4 reaction is life-threatening or requires urgent intervention. Sources: Conroy T. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer. N Engl J Med. 2018;379(25):2395–2406. Kindler HL. A glimmer of hope for pancreatic cancer. N Engl J Med. 2018;379(25):2463–4. Primary Section Advisor: Gary C. Yee (Click for more...) Antiepileptic drugs associated with serious skin reactions 2/5/2019 11:37:52 AM Primary Category: NeurologyKey point: The risk of serious adverse skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) is increased with use of antiepileptic drugs (AEDs) compared with non-AEDs, with the highest risks observed with zonisamide, rufinamide (Banzel—Eisai), clorazepate, lamotrigine, phenytoin, and carbamazepine, according to a review of FDA’s Adverse Event Reporting System (FAERS) published in Epilepsia. Finer points: SJS and TEN are serious and potentially fatal adverse skin reactions that have been reported with select medications, with AEDs being a class of drugs associated with these events. Researchers from Rhode Island conducted a retrospective review of adverse events reported to FAERS from July 2014 to December 2017 to determine the reporting rates of SJS and TEN with AEDs and non-AEDs. Over 42 months, a total of 2,886,886 adverse reactions were identified, with 1,035 being SJS/TEN reactions. AEDs were the most common medications associated with SJS/TEN reactions (n =198, 19.1%), followed by NSAIDs (n = 80, 7.7%). Thirty-four AEDs were evaluated, with 17 of these agents having one or more reports of SJS/TEN reactions. The investigators assessed the reporting odds ratio (ROR) and proportional reporting ratio (PRR) and found that for AEDs as a class, the ROR was 8.7 (95% CI 7.5–10.2), and the PRR was 8.7 (7.5–10.2) compared with non-AEDs. The highest RORs and PRRs were observed for zonisamide (ROR 70.2, PRR 68.7), rufinamide (ROR 60.0, PRR 58.9), clorazepate (ROR 56.0, PRR 55.1), lamotrigine (ROR 53.0, PRR 52.2), phenytoin (ROR 26.3, PRR 26.1), and carbamazepine (ROR 24.5, PRR 24.3). Significant associations for SJS/TEN were also observed for valproic acid, eslicarbazepine (Aptiom—Sunovion Pharmaceuticals), oxcarbazepine, clonazepam, and levetiracetam. What you need to know: The current results suggest that AEDs are associated with an increased risk of SJS/TEN compared with other medications, and select AEDs are associated with the highest risks. Pharmacists should be aware that the typical clinical course of SJS/TEN begins within 8 weeks following the first exposure to the causative agent, although some cases have been reported with long-term use. Patients may present with symptoms that include fever, rash, headache, sore throat, cough, or malaise, and blister-like lesions on the trunk or mucous membranes. The authors noted that an approach to preventing these cutaneous reactions might be to start with a low dose and titrate up slowly as tolerated by the patient (i.e., as is done with lamotrigine). However, they acknowledged that additional research is needed to evaluate this approach to determine if it can decrease the risk of SJS/TEN with specific AEDs. They concluded, “Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS/TEN signs/symptoms, may help mitigate the number and severity of these adverse events.” What your patients need to know: Inform patients and caregivers of children using AEDs to manage epilepsy or for other indications that these medications can cause serious skin reactions such as SJS/TEN. Educate them on the signs of these types of reactions, such as fever, tiredness, and skin manifestations (e.g., blister-like rashes), and remind them to report any symptoms to their provider immediately. Sources: Borrelli EP, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: an analysis of the US Food and Drug Administration Adverse Event Reporting System. Epilepsia. 2018;59(12):2318–24. Primary Section Advisor: Jack J. Chen (Click for more...) Scholarships available for tobacco cessation continuing education 2/5/2019 12:00:00 AM More than 20 scholarships are available for health care professionals interested in the School of Dentistry continuing education program on tobacco cessation treatment. (Click for more...) 2% Lidocaine Hydrochloride Topical Jelly 2/4/2019 7:00:00 PM Drug: 2% Lidocaine Hydrochloride Topical Jelly, Revision Date: Tue, 05 Feb 2019 (Click for more...) Indocyanine Green 2/4/2019 7:00:00 PM Drug: Indocyanine Green, Revision Date: Tue, 05 Feb 2019 (Click for more...) Proparacaine Hydrochloride Ophthalmic Solution 2/4/2019 7:00:00 PM Drug: Proparacaine Hydrochloride Ophthalmic Solution, Revision Date: Tue, 05 Feb 2019 (Click for more...) WVU researchers pen op-ed promoting vaccinations 2/4/2019 12:00:00 AM HPML Assistant Professor Lindsay Allen, along with four other WVU researchers, recently published an op-ed in the Charleston Gazette-Mail calling for an end to the vaccine debate in the wake of Senate Bill 454 and the measles outbreak in Washington and Oregon. (Click for more...) 14.6% Sodium Chloride Concentrated Solution for Injection 2/3/2019 7:00:00 PM Drug: 14.6% Sodium Chloride Concentrated Solution for Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Bacteriostatic 0.9% Sodium Chloride Vials 2/3/2019 7:00:00 PM Drug: Bacteriostatic 0.9% Sodium Chloride Vials, Revision Date: Mon, 04 Feb 2019 (Click for more...) Calcium Gluconate Injection 2/3/2019 7:00:00 PM Drug: Calcium Gluconate Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Carbidopa and Levodopa Extended-Release Tablets 2/3/2019 7:00:00 PM Drug: Carbidopa and Levodopa Extended-Release Tablets, Revision Date: Mon, 04 Feb 2019 (Click for more...) Cefazolin Injection 2/3/2019 7:00:00 PM Drug: Cefazolin Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Cefoxitin Sodium Injection 2/3/2019 7:00:00 PM Drug: Cefoxitin Sodium Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection 2/3/2019 7:00:00 PM Drug: Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Diphenhydramine Injection 2/3/2019 7:00:00 PM Drug: Diphenhydramine Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Dobutamine Injection 2/3/2019 7:00:00 PM Drug: Dobutamine Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Epinephrine Injection 2/3/2019 7:00:00 PM Drug: Epinephrine Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Flumazenil Injection 2/3/2019 7:00:00 PM Drug: Flumazenil Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Labetalol Injection 2/3/2019 7:00:00 PM Drug: Labetalol Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Mannitol Injection 2/3/2019 7:00:00 PM Drug: Mannitol Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Methyldopa Tablets 2/3/2019 7:00:00 PM Drug: Methyldopa Tablets, Revision Date: Mon, 04 Feb 2019 (Click for more...) Morphine Injection 2/3/2019 7:00:00 PM Drug: Morphine Injection, Revision Date: Mon, 04 Feb 2019 (Click for more...) Sterile Water for Injection - Small Volume Vials 2/3/2019 7:00:00 PM Drug: Sterile Water for Injection - Small Volume Vials, Revision Date: Mon, 04 Feb 2019 (Click for more...) FDA issues urgent recall of test strips used to monitor warfarin levels at home 2/1/2019 2:52:00 PM Generic Name: Test stripsTrade Name: CoaguChek XS PT Test StripsCompany: Roche Diagnostics, Terrific Care/Medex SupplyNotes: FDA is warning that CoaguChek XS PT Test Strips used with CoaguChek test meter devices to monitor warfarin levels may provide results that are higher than the actual INR and should not be relied upon to adjust the drug dosage. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or be instructed to interrupt warfarin use. This may increase the risk for dangerous blood clots. FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics recall, which is still in effect and involved more than 1.1 million packages that were distributed nationwide from January 12, 2018, to October 29, 2018. The test strips were manufactured by Roche but distributed by Terrific Care/Medex Supply. They include catalog numbers that were not in the previous Roche recall because the strips were not labeled or authorized for sale in the United States and were only distributed by Roche outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the United States. Incorrect INR results are of particular concern for individuals at an increased risk of blood clots, including those with mechanical heart valves, those with atrial fibrillation who are at high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient. The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices. Patients and health care providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method. All health care providers, patients, and caregivers are strongly encouraged to voluntarily report INR test meter problems directly to FDA through MedWatch. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death. FDA said it will provide updates related to this recall when they are available. Medication Monitor Categories: Alerts and Recalls (Click for more...) 0.9% Sodium Chloride Large Volume Bags 1/31/2019 7:00:00 PM Drug: 0.9% Sodium Chloride Large Volume Bags, Revision Date: Fri, 01 Feb 2019 (Click for more...) Atropine Sulfate Injection 1/31/2019 7:00:00 PM Drug: Atropine Sulfate Injection, Revision Date: Fri, 01 Feb 2019 (Click for more...) Epinephrine Auto-Injectors 1/31/2019 7:00:00 PM Drug: Epinephrine Auto-Injectors, Revision Date: Fri, 01 Feb 2019 (Click for more...) Morphine PCA Vials 1/31/2019 7:00:00 PM Drug: Morphine PCA Vials, Revision Date: Fri, 01 Feb 2019 (Click for more...) PCA Sterile Empty Vials and Injector 1/31/2019 7:00:00 PM Drug: PCA Sterile Empty Vials and Injector, Revision Date: Fri, 01 Feb 2019 (Click for more...) Bisoprolol Fumarate Tablets 1/30/2019 7:00:00 PM Drug: Bisoprolol Fumarate Tablets, Revision Date: Thu, 31 Jan 2019 (Click for more...) Butorphanol Tartrate Injection 1/30/2019 7:00:00 PM Drug: Butorphanol Tartrate Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Ceftriaxone Sodium Injection 1/30/2019 7:00:00 PM Drug: Ceftriaxone Sodium Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Fludrocortisone Acetate Tablets 1/30/2019 7:00:00 PM Drug: Fludrocortisone Acetate Tablets, Revision Date: Thu, 31 Jan 2019 (Click for more...) Leuprolide Acetate 14-Day Kit 1/30/2019 7:00:00 PM Drug: Leuprolide Acetate 14-Day Kit, Revision Date: Thu, 31 Jan 2019 (Click for more...) Mycophenolate Mofetil Capsules and Tablets 1/30/2019 7:00:00 PM Drug: Mycophenolate Mofetil Capsules and Tablets, Revision Date: Thu, 31 Jan 2019 (Click for more...) Octreotide Injection 1/30/2019 7:00:00 PM Drug: Octreotide Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Olanzapine Intramuscular Injection 1/30/2019 7:00:00 PM Drug: Olanzapine Intramuscular Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) RimabotulintoxinB Intramuscular Injection 1/30/2019 7:00:00 PM Drug: RimabotulintoxinB Intramuscular Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Testosterone Enanthate Intramuscular Injection 1/30/2019 7:00:00 PM Drug: Testosterone Enanthate Intramuscular Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Oxacillin Sodium Injection 1/30/2019 7:00:00 PM Drug: Oxacillin Sodium Injection, Revision Date: Thu, 31 Jan 2019 (Click for more...) Nominations for annual Vice President's Awards open Feb. 1 1/30/2019 12:00:00 AM The annual Vice President's Awards Committee is now accepting nominations. This is your opportunity to honor and recognize employees at the WVU Health Sciences Center. Nominations can be submitted starting Friday, February 1. The form will remain open through Thursday, February 28. (Click for more...) Alcohol Dehydrated Injection (Ethanol) 1/29/2019 7:00:00 PM Drug: Alcohol Dehydrated Injection (Ethanol), Revision Date: Wed, 30 Jan 2019 (Click for more...) Asparaginase Erwinia chrysanthemi 1/29/2019 7:00:00 PM Drug: Asparaginase Erwinia chrysanthemi, Revision Date: Wed, 30 Jan 2019 (Click for more...) Atropine Ophthalmic Solution 1/29/2019 7:00:00 PM Drug: Atropine Ophthalmic Solution, Revision Date: Wed, 30 Jan 2019 (Click for more...) Ceftazidime Injection 1/29/2019 7:00:00 PM Drug: Ceftazidime Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Daptomycin Injection 1/29/2019 7:00:00 PM Drug: Daptomycin Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Hydroxyethyl Starch in Sodium Chloride Injection 1/29/2019 7:00:00 PM Drug: Hydroxyethyl Starch in Sodium Chloride Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Iopamidol Injection 1/29/2019 7:00:00 PM Drug: Iopamidol Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Lorazepam Injection 1/29/2019 7:00:00 PM Drug: Lorazepam Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Methylene Blue 1/29/2019 7:00:00 PM Drug: Methylene Blue, Revision Date: Wed, 30 Jan 2019 (Click for more...) Methylphenidate Extended-Release Oral Suspension and Chewable Tablets 1/29/2019 7:00:00 PM Drug: Methylphenidate Extended-Release Oral Suspension and Chewable Tablets, Revision Date: Wed, 30 Jan 2019 (Click for more...) Metronidazole Hydrochloride Injection 1/29/2019 7:00:00 PM Drug: Metronidazole Hydrochloride Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution 1/29/2019 7:00:00 PM Drug: Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution, Revision Date: Wed, 30 Jan 2019 (Click for more...) Ranitidine Injection 1/29/2019 7:00:00 PM Drug: Ranitidine Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Remifentanil Injection 1/29/2019 7:00:00 PM Drug: Remifentanil Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Scopolamine Transdermal System 1/29/2019 7:00:00 PM Drug: Scopolamine Transdermal System, Revision Date: Wed, 30 Jan 2019 (Click for more...) Sufentanil Injection 1/29/2019 7:00:00 PM Drug: Sufentanil Injection, Revision Date: Wed, 30 Jan 2019 (Click for more...) Yellow Fever Vaccine 1/29/2019 7:00:00 PM Drug: Yellow Fever Vaccine, Revision Date: Wed, 30 Jan 2019 (Click for more...) Piperacillin and Tazobactam Injection 1/28/2019 7:00:00 PM Drug: Piperacillin and Tazobactam Injection, Revision Date: Tue, 29 Jan 2019 (Click for more...) Dexrazoxane Injection 1/27/2019 7:00:00 PM Drug: Dexrazoxane Injection, Revision Date: Mon, 28 Jan 2019 (Click for more...) Lidocaine Injection 1/27/2019 7:00:00 PM Drug: Lidocaine Injection, Revision Date: Mon, 28 Jan 2019 (Click for more...) Methadone Injection 1/27/2019 7:00:00 PM Drug: Methadone Injection, Revision Date: Mon, 28 Jan 2019 (Click for more...) Predictive Analytics Help Identify Drug Candidate Molecules 1/25/2019 9:10:08 PM The process of discovering a viable drug candidate molecule is often time-consuming and research-intensive. A lab must test thousands of compounds every day — and a hit rate of just 1 percent is considered above average. Even after a potentially viable molecule has been discovered, a pharmaceutical developer must invest significant time and resources into […] (Click for more...) Government Shutdown Could Have Lasting Impact on Scientific Research 1/25/2019 8:27:08 PM The U.S. government shutdown dragged on past the one-month mark, creating financial panic for many government workers and resulting in a ripple of negative affects across the country. In the pharmaceutical industry, the primary concerns have been centered around FDA approvals and patient safety issues, as we discussed in an earlier post. The shutdown has […] (Click for more...) Cefotaxime Sodium Injection 1/24/2019 7:00:00 PM Drug: Cefotaxime Sodium Injection, Revision Date: Fri, 25 Jan 2019 (Click for more...) Doxorubicin Injection 1/24/2019 7:00:00 PM Drug: Doxorubicin Injection, Revision Date: Fri, 25 Jan 2019 (Click for more...) Morphine Sulfate Immediate-Release Tablets 1/24/2019 7:00:00 PM Drug: Morphine Sulfate Immediate-Release Tablets, Revision Date: Fri, 25 Jan 2019 (Click for more...) 5% Dextrose Injection 1/23/2019 7:00:00 PM Drug: 5% Dextrose Injection, Revision Date: Thu, 24 Jan 2019