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...
PharmaTimes CROY 2019 - deadline extended 1/17/2019 7:27:57 AM It’s not too late! The deadline for the PharmaTimes Clinical Researcher of the Year (CROY) 2019 awards has been extended to the February 25. (Click for more...) NICE approval for Verzenios in metastatic breast cancer 1/17/2019 7:22:17 AM The National Institute for Health and Care Excellence has recommended Eli Lilly’s Verzenios in combination with an aromatase inhibitor as treatment option for locally advanced or metastatic breast cancer (Click for more...) EU licence granted for Erleada in prostate cancer 1/17/2019 7:16:15 AM Janssen’s new treatment for prostate cancer Erleada has been licensed by the European Commission. (Click for more...) Scholl and COP announce partnership 1/17/2019 7:12:42 AM Footcare brand Scholl has announced it is joining forces with The College of Podiatry (COP) to raise awareness of foot health. (Click for more...) ‘Innovative’ new disease and infection test 1/17/2019 6:57:27 AM Queen’s University researchers have developed a new test to detect disease and infection that could save time, money and possibly lives. (Click for more...) Growth, recognition, results—and an important partnership 1/16/2019 9:50:41 PM Here at Sigilon Therapeutics, we have had a very exciting period of growth recently, including receiving an Advanced Therapy Medicinal Product (ATMP) designation from the European Medicines Agency, adding two new members to our leadership team and initiating a collaboration with Eli Lilly in type 1 diabetes. We are very pleased that Eli Lilly recognized […] (Click for more...) Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue 1/16/2019 8:42:55 PM The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. But as the shutdown has continued to drag on into the new year, the ripple effects are hitting more and more people […] (Click for more...) Avoiding Pitfalls and Costly Mistakes in Early Stage R&D 1/16/2019 8:10:40 PM Pharma R&D costs continue to rise rapidly. A well-known Tufts study estimated the average pre-tax cost per new approved prescription drug (including failures and capital costs) was nearly $2.6 billion in 2013. However, the creation of novel approved drugs has not kept up with investment over the past two decades. To avoid the risks and […] (Click for more...) Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote 1/16/2019 5:54:24 PM If you thought Amgen osteoporosis candidate Evenity was down for the count, think again. After an overwhelmingly positive 18-1 vote in favor of approval from an FDA advisory panel Wednesday afternoon, the drug is “back in the game,” as Jefferies analyst Michael Yee put it in a note to clients. (Click for more...) Assessment of spending in Medicare Part D if medication prices from the VA were used 1/16/2019 5:05:01 PM Assessment of spending in Medicare Part D if medication prices from the VA were used Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 The Department of Veterans Affairs, which has secured deep discounts on medications by following a national formulary and negotiating directly with manufacturers, is often suggested as potential model for cutting prescription drug costs. Previous estimates of the savings that could be generated from copying the VA's protocol have not, however, used actual prices paid by the VA—which often are lower than published federal prices. For a more accurate comparison of potential Medicare Part D savings at VA pricing, researchers tapped into the most recent national data available from both parties. Those numbers covered the years from 2011 through 2016. Also, to create equity between the two sets of data, Medicare dollars were adjusted downward to account for patient payments, rebates, and a dispensing fee—none of which apply to the VA figures. VA per-unit costs were applied to Medicare to tabulate how much Medicare would spend each year if it paid VA prices for the same quantity of prescription drugs. Based on analysis of just 50 medications, the study found that Medicare potentially could have saved $14.4 billion in 2016 under this formula. (Click for more...) FDA investigates foreign plants that made drugs with cancer-causing impurities 1/16/2019 5:05:01 PM FDA investigates foreign plants that made drugs with cancer-causing impurities Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 FDA has launched an investigation of plants in China and India that produced carcinogen-tainted ingredients that led to numerous recalls of blood pressure drugs in recent months. Drug firms recalled many lots of angiotensin II receptor blockers, including the front-line blood pressure and heart medications valsartan, losartan, and irbesartan—alone or in combination with other drugs—after trace amounts of cancer-causing impurities were detected by testing. FDA inspections indicated China's Zhejiang Huahai Pharmaceutical factory and India's Hetero Labs were having problems before the discovery of the contaminated drugs. Workers at the Chinese facility, which was the source of the blood pressure drug recalls, frequently failed to probe testing anomalies in drug batches, while fraying gaskets, rusted screws, and missing pieces also were observed. Yet the factory remained in operation despite these findings. A later inspection found intolerable levels of the carcinogen nitrosodimethylamine (NDMA), which prompted FDA investigation in June and a recall in July. Follow-up testing identified another carcinogen, nitrosodiethylamine (NDEA), in batches of valsartan. Problems FDA cited at the Indian plant included failures to check discrepancies in drug batches and infrequent cleaning, sanitization, or sterilization of equipment to prevent drug ingredient contamination. (Click for more...) 6 trends driving pharmacy's future 1/16/2019 5:05:01 PM 6 trends driving pharmacy's future Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Chris Dimos, president of retail solutions at McKesson, recently identified six trends in the pharmacy industry. He noted that brand names dominated, then generic, and now specialty and biosimilars are popular. He also said the industry is "seeing changes in how we're going to think about government involvement, and as more people age into Medicaid and Medicare, how that will influence our patients' experiences and our practices." Pricing pressures are also increasing, but there is "a willingness to reimburse services that lead to an enhanced patient experience," he said. Dimos added that many companies are consolidating, and at the same time new nontraditional health care entrants are entering the market. Meanwhile, patients are more tech savvy and have asked for tools to optimize their health care experience. (Click for more...) Fed up with high prices, drug shortages, Advocate and other hospitals create not-for-profit drug company 1/16/2019 5:05:01 PM Fed up with high prices, drug shortages, Advocate and other hospitals create not-for-profit drug company Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Advocate Aurora Health, a large hospital system in Illinois and Wisconsin, has partnered with not-for-profit generic drug company Civica Rx to potentially pay up to 50% less for some medicines. Civica Rx was established last year by philanthropic groups and seven other health systems that sought to combat shortages and high prices of generic drugs by making their own. In exchange for investments in Civica Rx, Advocate and the other systems will help choose which drugs the company will produce and later be able to purchase those drugs. The goal is for Civica Rx to provide the hospitals with a more reliable supply of affordable generic drugs so that hospitals can pass savings on to patients. The company predicts that for some of the drugs it produces, it will be able to slash the prices paid by hospitals by 35% to 50%. Civica Rx has already chosen 14 hospital-administered generic drugs to focus on bringing to market later this year. Civica Rx is working to gain FDA approval to become a manufacturer, and it plans to either directly manufacture the drugs or contract with other manufacturers. Initially, only hospitals—not individual consumers—will be able to purchase Civica Rx's medications, though that could eventually change, said Heather Wall, chief commercial officer for Civica Rx. (Click for more...) Sacklers directed efforts to mislead public about oxycodone, new documents indicate 1/16/2019 5:05:01 PM Sacklers directed efforts to mislead public about oxycodone, new documents indicate Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Members of the Sackler family, which owns Purdue Pharma, directed years of efforts to mislead doctors and patients about the dangers of oxycodone (OxyContin), according to a court filing citing previously undisclosed documents. When evidence of growing abuse of the drug became clear in the early 2000s, one of them, Richard Sackler, recommended a strategy of blaming those who had become addicted. "We have to hammer on abusers in every way possible," Sackler wrote in an email in 2001, when he was president of the company. "They are the culprits and the problem. They are reckless criminals." That email and other internal Purdue communications are cited by the attorney general of Massachusetts in a new court filing against the company, released on Tuesday. The filing contends that Sackler urged that sales representatives advise doctors to prescribe the highest dosage of the powerful opioid analgesic because it was the most profitable. In a statement, Purdue Pharma rejected suggestions of wrongdoing by the company or members of the Sackler family, describing the court filing as "littered with biases and inaccurate characterizations." The statement said the company was working to curtail the use and misuse of opioid analgesics. (Click for more...) FDA restarts some drug, biologic and device Inspections 1/16/2019 5:05:01 PM FDA restarts some drug, biologic and device Inspections Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 FDA Commissioner Scott Gottlieb said Tuesday that about 400 employees at his agency will return to work without pay amid the ongoing partial government shutdown. In a tweet, Gottlieb said, "The vast majority are inspectors and others are professionals who work in support inspectors." Approximately 100 of the employees will deal with high-risk medical device manufacturing facilities, he said, while about 70 deal with inspections of high-risk drug manufacturing facilities, 90 will inspect high-risk biologic manufacturing sites, and the rest will work on food inspections. Gottlieb also said that no inspections have been missed since the shutdown began, noting that none had been scheduled and that the schedule just following the holidays would have reduced. He said the inspections will now be scheduled, however. (Click for more...) Bill would allow pharmacists in Arkansas to give birth control without prescription 1/16/2019 5:05:01 PM Bill would allow pharmacists in Arkansas to give birth control without prescription Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Proposed legislation in Arkansas would permit pharmacists in the state to dispense oral contraceptives without a prescription. The measure, which has been referred to the Public Health, Welfare, and Labor Committee in the House, would allow pharmacists to provide birth control to individuals age 18 years or older. The bill was introduced by state Rep. Aaron Pilkington (R-Clarksville). (Click for more...) FDA approved record number of drugs in 2018 1/16/2019 5:05:01 PM FDA approved record number of drugs in 2018 Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 FDA's Center for Drug Evaluation and Research (CDER) approved 59 new drugs in 2018, including 19 first-in-class agents, 34 novel drugs for rare diseases, and 7 biosimilars. Forty-three of these newly approved drugs (73%) had priority review, 24 (41%) were fast tracked, and 14 (24%) were designated as breakthrough therapies. The first drug derived from marijuana to be cleared by FDA was a purified formulation of cannabidiol (Epidiolex—GW Pharmaceuticals) for the treatment of seizures related to two rare forms of epilepsy for patients older than 2 years. FDA also approved a second new medication for Dravet syndrome: stiripentol (Diacomit—Biocodex). Another drug approval for rare or orphan diseases was migalastat (Galafold—Amicus Therapeutics) for Fabry disease. Meanwhile, FDA approved a new antiviral influenza treatment featuring a novel mechanism of action. Baloxavir marboxil (Xofluza—Shionogi) is approved for the treatment of acute uncomplicated influenza in people aged 12 years and older who have been symptomatic for no more than 48 hours. In the oncology/hematology field, approvals include duvelisib (Copiktra—Verstem Oncology) for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and glasdegib (Daurismo—Pfizer) for newly diagnosed acute myeloid leukemia in patients aged 75 years or older or those who have comorbidities that disallow use of intensive chemotherapy. (Click for more...) Walmart drops CVS pharmacy coverage in price dispute 1/16/2019 5:05:01 PM Walmart drops CVS pharmacy coverage in price dispute Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Walmart reported Tuesday that it will no longer honor prescription drug coverage from CVS Health, leaving large numbers of Walmart customers searching for a new pharmacist. The move affects Walmart customers with CVS Caremark pharmacy coverage through employer-sponsored insurance and state Medicaid managed-care plans. It does not affect Medicare beneficiaries. It also does not affect pharmacies at Sam's Club stores. CVS recently refused Walmart's demand for larger reimbursements for the prescription drugs it dispenses. Rival pharmacies, especially small independent pharmacies that are getting squeezed, suspect that CVS Caremark plays favorites with affiliated CVS pharmacies. Walmart on Tuesday essentially accused CVS Health of using its clout to bully customers. "This issue underscores the problems that can arise when a PBM can exert their unregulated power to direct members on where to fill their scripts, disrupting patients’ health care," Walmart said in a statement. "Walmart is standing up to CVS’s behaviors that are putting pressure on pharmacies and disrupting patient care." CVS said Walmart’s demand for bigger reimbursements would result in increased costs. "At a time when everyone is working hard to find ways to reduce health care costs, Walmart’s requested rates would ultimately result in higher costs for our clients and consumers," CVS said in a statement. "The decision to leave the CVS Caremark commercial and Managed Medicaid community pharmacy networks was Walmart's, and Walmart’s alone." (Click for more...) FDA outlines plans to advance development of cell and gene therapies 1/16/2019 5:05:01 PM FDA outlines plans to advance development of cell and gene therapies Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 FDA Commissioner Scott Gottlieb, MD, and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, MD, PhD, detailed on Tuesday plans for FDA to keep pace with an anticipated surge in applications for cell and gene therapy products in the coming years. "We anticipate that by 2020 we will be receiving more than 200 INDs per year, building upon our total of more than 800 active cell-based or directly administered gene therapy [investigational new drug applications] currently on file with the FDA," they wrote. "And by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products." They noted they aim to eventually add about 50 more clinical reviewers to the group tasked with overseeing the clinical investigation, development, and review of these products. Additionally, they will work with sponsors to make maximum use of their expedited programs, including regenerative medicine advanced therapy designation and accelerated approval, and they are planning to issue a series of clinical guidance documents related to various areas of active product development. "Taken together," they said, "these guidance documents, along with other policies that we plan to issue in 2019, are aimed at helping advance the field of cell and gene therapy. ... Our efforts are aimed at helping innovators proactively address ... potential risks, while we outline a modern and efficient pathway for the continued development of these innovations." (Click for more...) Benzodiazepines may boost pneumonia risk, especially in older adults 1/16/2019 5:05:01 PM Benzodiazepines may boost pneumonia risk, especially in older adults Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Results from a systematic review and meta-analysis suggest that the odds for developing pneumonia were 1.25-fold greater among users of benzodiazepines and related drugs (BZRDs), including zolpidem, compared with nonusers. The investigation, reported in the International Journal of Geriatric Psychiatry, covered 10 studies and more than 120,000 pneumonia cases. The elevated risk of pneumonia applied to current BZRD users and anyone who received a prescription within 30–90 days, but not to people who had taken the drugs more than 3 months prior. The evidence also reflected a strong association in adults aged 65 years and older, who are big users of BZRDs and who also are vulnerable to pneumonia-related sickness and death. Additionally, short- and intermediate-acting BZRD formulations were linked to a markedly higher risk of pneumonia than long-acting preparations. A significantly increased risk was also observed with diazepam, lorazepam, temazepam, and zopiclose—but not with chloridazepoxide or clonazepam. The investigators, representing the Seventh Hospital of Hangzhou, China, concluded that BZRDs should be prescribed only to patients with clear indications. Moreover, "additional large-scale, well-designed studies with consideration of individual BZRD, current other drug use, and comorbid illness are needed to confirm or refute these results," they report. (Click for more...) Microsoft, Walgreens to leverage AI for retail-style health care 1/16/2019 5:05:01 PM Microsoft, Walgreens to leverage AI for retail-style health care Tue, 01/15/2019 - 19:00 cbaker_admin Wed, 01/16/2019 - 17:05 Walgreens Boots Alliance (WBA) and Microsoft are collaborating to apply artificial intelligence (AI) to the challenges of developing retail-style health care interactions. The two companies will work together to create innovative, cost-effective, consumer-centered health care experiences that leverage cloud-based data technologies and AI-driven strategies. Top priorities for the initiative include better chronic disease management, improvements in overall population health, and more effective patient engagement tools. "Improving health outcomes while lowering the cost of care is a complex challenge that requires broad collaboration and strong partnership between the health care and tech industries," said Satya Nadella, chief executive officer of Microsoft. "Together with WBA, we aim to deliver on this promise by putting people at the center of their health and wellness, combining the power of the Azure cloud and AI technology and Microsoft 365 with WBA's deep expertise and commitment to helping communities around the world lead healthier and happier lives." In 2019, Walgreens will launch a pilot of up to 12 store-in-store digital health corners designed to showcase and sell select health care-related hardware and devices. "Our strategic partnership with Microsoft demonstrates our strong commitment to creating integrated, next-generation, digitally enabled health care delivery solutions for our customers, transforming our stores into modern neighborhood health destinations and expanding customer offerings," said Stefano Pessina, executive vice chairman and chief executive officer of WBA. (Click for more...) New and emerging considerations in Parkinson’s disease 1/16/2019 1:57:06 PM New and emerging considerations in Parkinson’s disease Wed, 01/16/2019 - 14:10 caldridgeyoung… Wed, 01/16/2019 - 13:57 With roughly 1.5 million Americans diagnosed and 50,000 new incurable cases each year, Parkinson’s disease (PD) has become a prevalent condition in the United States. For some time, the cornerstone of treatment was with levodopa and carbidopa, but in our ever-aging population, medications are needed to address “off” episodes when drugs simply do not work and to treat debilitating symptoms of PD, such as tremor and gait difficulties. (Click for more...) Pfizer partners with Medochemie to make drugs in Vietnam 1/16/2019 11:42:20 AM Vietnam has transformed its economy from one of the world’s poorest to one that is comfortably middle income. Pfizer has taken note and formed a partnership to manufacture some of its drugs in the rapidly growing Asian market. (Click for more...) Reckitt CEO plots exit amid consumer health split, and investors aren't happy 1/16/2019 11:40:46 AM Back in 2017, Reckitt Benckiser CEO Rakesh Kapoor touched off some big changes for the company. But he won’t be sticking around long enough to see them through. (Click for more...) Acadia looks to 'blow up the paradigm' with Parkinson's psychosis drug Nuplazid 1/16/2019 10:34:36 AM When doctors first give patients their Parkinson’s diagnoses, their main focus is motor control. And Acadia Pharmaceuticals, maker of Parkinson’s psychosis drug Nuplazid, gets that. But that very fact has given Acadia a big job to do with Nuplazid. (Click for more...) FDA recalls inspectors as shutdown drags on; Gottlieb calls PDUFA most 'vulnerable' 1/16/2019 10:13:54 AM With the government shutdown now in its fourth week—the longest ever—FDA Commissioner Scott Gottlieb says about 400 staff have been recalled to restart inspections, with most of those targeted at drug, biologics and device inspections. (Click for more...) Sackler family directed—and covered up—Purdue's opioid sales tactics. Now, it should pay the price: AG 1/16/2019 9:51:21 AM The Sackler family directed Purdue sales tactics for OxyContin and should be held responsible for the state's opioid crisis, Massachusetts' AG argued in an amended lawsuit. (Click for more...) Allergan and Mohawk tribe ask SCOTUS to review controversial Restasis patent licensing deal 1/16/2019 9:48:57 AM Can tribal immunity shield a drug from patent challenge? Allergan and the Mohawk tribe want the Supreme Court to weigh in on their controversial deal aimed at doing just that for the drugmaker's blockbuster Restasis. (Click for more...) NICE endorsement means more donor livers could be used for transplantation 1/16/2019 8:34:29 AM The National Institute for Health and Care Excellence has announced that an “exciting development” could increase the number of livers which can be safely used for transplantation. (Click for more...) New breast cancer testing tool in development 1/16/2019 8:30:30 AM A study carried out by researchers from the University of Cambridge, National Cancer Institute, National Institutes of Health in the US among others has shown how putting different genetic and risk factor data into a prediction equation could help us understand how likely a woman is to develop breast cancer. (Click for more...) GSK extends expiration date for Tesaro offer 1/16/2019 8:26:07 AM GlaxoSmithKline subsidiary Adriatic Acquisition Corporation (AAC) has extended the expiration date for its tender offer for US-based Tesaro. (Click for more...) Pharma comments on Brexit withdrawal rejection 1/16/2019 8:24:20 AM Pharmaceutical groups weigh in on the UK parliament’s rejection of the Brexit withdrawal agreement. (Click for more...) Merck bumps Keytruda credibility with real doctor appearance in latest ‘Tru’ patient ads 1/16/2019 7:49:24 AM Merck is changing the game again in oncology ads by adding a real doctor to its Keytruda patient campaign. Two new TV commercials feature oncologist Goetz Kloecker, M.D., talking about his firsthand experience with the drug. (Click for more...) Psychosis patients waiting for NHS treatment 1/16/2019 4:44:06 AM Over a thousand people with psychosis are still waiting for treatment on the NHS. (Click for more...) ‘Professional Standards for Community Pharmacy Services’ to be set 1/16/2019 4:39:14 AM The Royal Pharmaceutical Society has begun to produce its first ever ‘Professional Standards for Community Pharmacy Services’. (Click for more...) BCG Live Intravesical 1/15/2019 7:00:00 PM Drug: BCG Live Intravesical, Revision Date: Wed, 16 Jan 2019 (Click for more...) Cefepime Injection 1/15/2019 7:00:00 PM Drug: Cefepime Injection, Revision Date: Wed, 16 Jan 2019 (Click for more...) Cefoxitin Sodium Injection 1/15/2019 7:00:00 PM Drug: Cefoxitin Sodium Injection, Revision Date: Wed, 16 Jan 2019 (Click for more...) Dicyclomine Injection 1/15/2019 7:00:00 PM Drug: Dicyclomine Injection, Revision Date: Wed, 16 Jan 2019 (Click for more...) Heparin Sodium Premixed Bags 1/15/2019 7:00:00 PM Drug: Heparin Sodium Premixed Bags, Revision Date: Wed, 16 Jan 2019 (Click for more...) Levothyroxine Sodium Injection 1/15/2019 7:00:00 PM Drug: Levothyroxine Sodium Injection, Revision Date: Wed, 16 Jan 2019 (Click for more...) Mineral Oil and Petrolatum Ophthalmic Ointment 1/15/2019 7:00:00 PM Drug: Mineral Oil and Petrolatum Ophthalmic Ointment, Revision Date: Wed, 16 Jan 2019 (Click for more...) Nitrofurantoin Oral Suspension 1/15/2019 7:00:00 PM Drug: Nitrofurantoin Oral Suspension, Revision Date: Wed, 16 Jan 2019 (Click for more...) Pentamidine Isethionate 1/15/2019 7:00:00 PM Drug: Pentamidine Isethionate, Revision Date: Wed, 16 Jan 2019 (Click for more...) Sodium Polystyrene Sulfonate Oral or Rectal Suspension 1/15/2019 7:00:00 PM Drug: Sodium Polystyrene Sulfonate Oral or Rectal Suspension, Revision Date: Wed, 16 Jan 2019 (Click for more...) Sterile Talc 1/15/2019 7:00:00 PM Drug: Sterile Talc, Revision Date: Wed, 16 Jan 2019 (Click for more...) Thrombin Topical Solution (Bovine) 1/15/2019 7:00:00 PM Drug: Thrombin Topical Solution (Bovine), Revision Date: Wed, 16 Jan 2019 (Click for more...) Eflornithine Hydrochloride Cream 1/15/2019 7:00:00 PM Drug: Eflornithine Hydrochloride Cream, Revision Date: Wed, 16 Jan 2019 (Click for more...) Theophylline 12-Hour Extended-Release Tablets 1/15/2019 7:00:00 PM Drug: Theophylline 12-Hour Extended-Release Tablets, Revision Date: Wed, 16 Jan 2019 (Click for more...) Pet opioid prescriptions have soared, Penn study finds. But who's really using the meds? 1/15/2019 4:05:01 PM Pet opioid prescriptions have soared, Penn study finds. But who's really using the meds? Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 An increase in prescriptions of pet opioids, detailed in a JAMA Network Open report, is stoking concerns about human diversion. New research by Penn Medicine and Penn Vet shows that prescriptions of tramadol, hydrocodone, oral codeine, and fentanyl patches for small animals climbed 41% from 2007–17. Because the surge was not matched by pet hospital visits, which increased just 13% over the same period, the finding amplifies existing fears that medications prescribed to ease pet pain are being diverted for human consumption. Earlier reports have even suggested that some owners intentionally hurt or sicken a pet in order to gain access to the drugs. At the federal level, the problem prompted FDA Administrator Scott Gottlieb to issue a statement last summer acknowledging the potential for "addiction, abuse, and overdose in humans" who abuse veterinarian-prescribed opioids. He encouraged animal doctors to selectively prescribe opioids, use alternatives when possible, and educate pet owners about safe opioid storage and disposal. Meanwhile, Pennsylvania and other states are creating new medication restrictions, such as limiting how many opioids can be prescribed to a single pet, looking at owners' previous opioid uses, and requiring vets to report prescription activity to a central database. (Click for more...) Pediatric Trials Network studies lead to medication label changes 1/15/2019 4:05:01 PM Pediatric Trials Network studies lead to medication label changes Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 The Pediatric Trials Network (PTN), housed within the Duke Clinical Research Institute, has had a significant role in mediating medication label changes to include dosing, safety, and efficacy information specifically for infants and children. This data historically has been elusive because of difficulty in predicting dose response, questions about long-term health and development outcomes, and ethical quandaries. The PTN, however, creates an enriched academic environment and infrastructure where researchers, thought leaders, and trial operations collaborate to develop meaningful clinical drug trials for children. The data generated by these projects helps regulators update drug labels for pediatric application, in line with the goals of the Best Pharmaceuticals for Children Act. Of 21 medical drugs and devices submitted to FDA for label changes, eight have been approved—most recently, for lisinopril and meropenem—and three others are expected to be sanctioned this year for ampicillin, clindamycin, and acyclovir. Meanwhile, eight clinical trials are currently underway. (Click for more...) The strange marketplace for diabetes test strips 1/15/2019 4:05:01 PM The strange marketplace for diabetes test strips Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 More than 30 million Americans have type 1 or type 2 diabetes, and most use several test strips daily to monitor their condition, leading to a vast resale market that has existed for decades. Often the sellers are insured and paid little out of pocket for the strips; the buyers may be underinsured or uninsured, and unable to pay retail prices, which can run well over $100 for a box of 100 strips. A 2012 study found that among insulin-dependent patients who monitor their blood sugar, strips accounted for nearly one-quarter of pharmacy costs. In a community pharmacy, name-brand strips command high prices, but that does not reflect what most people pay. Manufacturers set a high list price and then negotiate to become an insurer's preferred supplier by offering a hefty rebate. The arrangement leaves the uninsured paying high sticker prices out of pocket. Also left out are the underinsured, who may need to first satisfy a high deductible. Some manufacturers now sell patients proprietary meters designed to read only their brand of strips. If a patient's insurer shifts her to a new brand, she must get a new meter, often leaving behind a supply of useless strips. While some resellers use websites like Amazon or eBay to market strips directly to consumers, the biggest profits are in returning them to community pharmacies, which sell them as new and bill the customer's insurance the full price. (Click for more...) CVS Health launches $100 million building healthier communities initiative 1/15/2019 4:05:01 PM CVS Health launches $100 million building healthier communities initiative Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 CVS Health announced Wednesday a $100 million commitment to making community health and wellness a focus of its efforts for a better world. The Building Healthier Communities initiative will be funded over 5 years through the newly combined CVS Health and Aetna and also the CVS Health Foundation and Aetna Foundation. According to CVS Health, the effort will build on the two companies' past community efforts and use their scale and resources to further a strategy that will have a measurable effect on the health of U.S. communities. "We believe the path to better health and a better world can be reached by creating a whole new health care model that's more local, affordable, and easier to use," said Larry Merlo, CVS Health president and CEO, in a speech on Monday. "And by strengthening our local support and community engagement, we can further improve the health of our communities." As part of the effort, CVS Health will invest $20 million a year in three funding categories to support a variety of initiatives and nonprofit groups. The company also said it plans to expand its Project Health campaign to target more underserved and underinsured communities, and it will continue to make strategic investments that enable access to local resources such as Meals on Wheels and community health centers. Additionally, CVS Health said it will make substantial investments in support of innovative approaches to managing chronic diseases and will continue to fight the opioid epidemic, directing funding to groups that are innovating in the area of addiction treatment. (Click for more...) Analysis of proposed Medicare reforms on prescription drug total spending and patient cost-sharing 1/15/2019 4:05:01 PM Analysis of proposed Medicare reforms on prescription drug total spending and patient cost-sharing Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 The HHS plan to shift coverage of some drugs from Medicare Part B to Part D may lower total drug spending, according to new research, but out-of-pocket costs for some beneficiaries may increase as a result. HHS announced the proposal in May 2018. To estimate the association of changes of a shift in Medicare Part B to Part D with total drug spending and patient cost-sharing, the retrospective drug cohort study included the 75 brand-name drugs linked to the highest Part B costs among fee-for-service Medicare beneficiaries in 2016. Total Medicare Part B spending for these drugs was an estimated $21.6 billion annually in 2018 prices. Under the proposed policy change, total Part D spending for these drugs would be $17.6 billion to $20.1 billion after rebates, for a 6.9% to 18.3% reduction in drug spending. However, 33 of the drugs (44%)—accounting for $9.5 billion in Part B spending—were in protected Part D classes that require plans to essentially cover all medications. According to the researchers, shifting coverage from Part B to Part D would reduce the median out-of-pocket costs by $860 among beneficiaries without Medicaid or Part B supplemental insurance (Medigap). For people with Medigap coverage, the estimated Part D out-of-pocket costs would exceed the average Medigap premium costs by an average of $1,460 for those with Part D coverage and $1,952 for those without Part D coverage. "As it implements this proposal, HHS should ensure that the proposed reforms benefit both patients and payers," the researchers conclude. (Click for more...) Health care marketing: Spending surges, oversight lags 1/15/2019 4:05:01 PM Health care marketing: Spending surges, oversight lags Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 Pharmaceutical companies have invested more heavily in product marketing in recent years, according to a review covering marketing practices and outlays from 1997 to 2016. The researchers—who consulted published studies, data from a media monitoring service, the Open Payments database at CMS, and the IQVIA Institute for Human Data Science—estimated that spending in this area surged from $17.7 billion to $29.9 billion over that time span. The trend was driven by a spike in direct-to-consumer advertising of drugs and health services, especially in the television format, as well as targeted campaigns to health care professionals. However, advertising in medical journals—one avenue to reach these caregivers—dropped from $744 million to $119 million during the study period, according to the team at the Center for Medicine in the Media in the Dartmouth Institute for Health Policy and Clinical Practice. They also noted that the escalation in medical marketing has not triggered an appropriately strong regulatory response, based on information from FDA, state attorneys general websites, and other local, state, and federal sources. While the study authors believe that tighter oversight is necessary, the likelihood of a ban to keep clinicians and other health care entities from marketing is slim. According to an editorial accompanying the research report in the Journal of the American Medical Association, all stakeholders must weigh the benefits and harms of health care marketing. "[T]he recognition that medical marketing is increasing its scope and scale, should be a call to action not only for regulators, but also for payers, physicians, and health care organizations," the editorialists concluded. (Click for more...) CLIA-waived POCT labs to launch in local pharmacies 1/15/2019 4:05:01 PM CLIA-waived POCT labs to launch in local pharmacies Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 Southeastern Grocers and eTrueNorth, a pharmacy-based clinical services network, have reached an agreement to open CLIA-waived laboratories in 253 community pharmacies. Southeastern Grocers locations with in-store pharmacies will use the eTrueNorth ePOCT Suite, which provides software to streamline administrative processes for CLIA-waived laboratory point-of-care testing. Southeastern Grocers brands Bi-Lo, Fresco y Mas, Harveys Supermarkets, and Winn-Dixie stores will take part in the eLabNetwork Voucher system that allows employers to gather biometric data from employees as part of well-being programs. The voucher system also enables employees who work remotely or who miss onsite wellness screenings to obtain prompt point-of-care testing at local pharmacies. Well-being program participants may obtain biometric screenings at local pharmacies through the program. Southern Grocers operates in Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, and South Carolina. (Click for more...) Why California pharmacies are rejecting some prescriptions for pain medications 1/15/2019 4:05:01 PM Why California pharmacies are rejecting some prescriptions for pain medications Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 Doctors in California report that pharmacies are rejecting prescriptions for controlled substances on prescription forms they used just last year. The doctors complain that the state did not send them notice of a January 1 change in forms. The California Medical Association (CMA) has been hearing from physicians throughout the state about this issue, said Anthony York, a spokesperson for the organization. CMA is working with the Medical Board of California, the California State Board of Pharmacy, and the California Department of Justice to ensure that providers can serve their patients effectively. Assembly Bill 1753, sponsored by Assemblyman Evan Low (D-Silicon Valley) went into effect on January 1. It limits the number of printers authorized to produce prescription pads for controlled substances and requires the forms have tamper-proof measures to make them easier to track and harder to use if stolen. The measures were intended, Low said, to help stem the opioid crisis. On Monday, Low issued a statement acknowledging there have been some problems with how the law is being implemented. In the statement, he said he has communicated his “grave concerns” in a letter to the Department of Justice, and is "committed to seeing that any legislative solution is signed into law immediately." (Click for more...) Cuomo wants to ban cigarette sales in pharmacies in New York State 1/15/2019 4:05:01 PM Cuomo wants to ban cigarette sales in pharmacies in New York State Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 A provision in Gov. Andrew Cuomo of New York's budget proposal would raise the minimum age to purchase tobacco and e-cigarette products in the state from 18 to 21 years. In addition, the proposal seeks to prohibit sales of tobacco and e-cigarette products in pharmacies throughout New York, limit their display in retail stores that are not adult-only, and require that e-cigarettes only be sold by licensed retailers. "With this comprehensive proposal, we are taking aggressive action to combat this very real public health crisis and curb the use of nicotine products before they result in deadly consequences for an entire generation of New Yorkers," Cuomo said. If approved, New York would become the seventh state to raise the tobacco age to 21 years and the second (after Massachusetts) to ban the sale of tobacco products in pharmacies. Already, more than two dozen counties and cities in New York have increased the tobacco age to 21 years. A new law banning pharmacies in New York City from selling cigarettes and tobacco products went into effect on January 1. (Click for more...) U.S. judge partially blocks Trump administration birth control rules 1/15/2019 4:05:01 PM U.S. judge partially blocks Trump administration birth control rules Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 U.S. District Judge Haywood Gilliam in Oakland, CA, approved on Sunday a request for a preliminary injunction that partially blocks some Trump administration rules that permit employers to opt out of providing health insurance that covers birth control for women from taking effect. The rules, set to take effect on January 14, would enable businesses or nonprofit groups to get exemptions to an Affordable Care Act requirement for contraceptive coverage on a moral or religious basis. The request for a preliminary injunction, led by California Attorney General Xavier Becerra, asked for a nationwide injunction; however, Gilliam limited his decision to the states challenging the rules. In addition to California, these states are: Connecticut, Delaware, Hawaii, Illinois, Maryland, Minnesota, New York, North Carolina, Rhode Island, Vermont, Washington, Virginia, and the District of Columbia. While he did not reach a final decision in the matter, Gilliam indicated the rules probably were in violation of federal law. (Click for more...) California's new prescription drug purchasing plan could become national model 1/15/2019 4:05:01 PM California's new prescription drug purchasing plan could become national model Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 An executive order signed by Gov. Gavin Newsom of California calls on state agencies to negotiate as a block to demand that drug companies reduce their prices. The plan involves eventually allowing private employers to join the consolidated purchasing block. Newsom instructed the state's Department of Health Care Services to begin negotiating the purchasing of prescription drugs for all 13 million recipients of Medi-Cal, the state's health care system for low-income patients. At present, the state represents 2 million Medi-Cal patients while the remainder are on managed health plans that negotiate their own drug rates. The Pharmaceutical Research and Manufacturers of America says it is reviewing the proposal. John Baackes, CEO of LA Care Health Plan, the largest Medi-Cal managed plan in the state, says: "It's worth it to see if it will produce better pricing." However, no information is yet available on how the initiative will be administered or how the state would handle customer service. Larry Levitt, senior vice president of the Kaiser Family Foundation, called Newsom's approach "promising," but he points out that the state cannot walk away from a negotiation because it has an obligation to make sure that Medi-Cal recipients can access the drugs they require. (Click for more...) Oversight committee launches major drug pricing investigation 1/15/2019 4:05:01 PM Oversight committee launches major drug pricing investigation Mon, 01/14/2019 - 19:00 cbaker_admin Tue, 01/15/2019 - 16:05 House Oversight and Reform Committee Chairman Elijah Cummings (D-MD) sent letters to 12 different drug companies seeking detailed information and documents about how the companies price their medications. The request is part of a new sweeping investigation into the industry's pricing practices. "For years, drug companies have been aggressively increasing prices on existing drugs and setting higher launch prices for new drugs while recording windfall profits," Cummings said in a statement. "The goals of this investigation are to determine why drug companies are increasing prices so dramatically, how drug companies are using the proceeds, and what steps can be taken to reduce prescription drug prices," he said. Cummings noted the committee is seeking detailed information and documents on price increases, investments in research and development, and corporate strategies to preserve market share and pricing power. (Click for more...) No means no: Global pharma group bans any and all gifts to doctors 1/15/2019 11:27:04 AM Goodbye, goodies. The International Federation of Pharmaceutical Manufacturers and Associations updated its guidelines for 2019 to eliminate all gifts from prescription drugmakers. (Click for more...) Acorda's sales team switches gears to push crucial Parkinson's launch Inbrija 1/15/2019 11:24:34 AM True to its word, Acorda has moved its entire salesforce over from generics-plagued Ampyra to new Parkinson’s launch Inbrija. But it’s not relying solely on that team to get the ball rolling. (Click for more...) Sen. Schumer curiously links Shingrix shortage to shutdown, but Glaxo says there's no connection 1/15/2019 11:05:10 AM GlaxoSmithKline has had a Shingrix shortage for months, but now Sen. Chuck Schumer is saying the government shutdown is making the situation worse. Fact is, the government reopening isn't likely to have any effect on the vaccine's scarcity. (Click for more...) Ohio hits provider status milestone with new law 1/15/2019 10:18:35 AM Ohio hits provider status milestone with new law Tue, 01/15/2019 - 10:25 ehaberkorn@aph… Tue, 01/15/2019 - 10:18 Ohio Gov. John Kasich has signed a new Ohio law that authorizes payment to pharmacists by the state’s Medicaid plan sponsors and other health plans. SB 265, which was introduced by Sen. Matt Dolan, is expected to become effective in April. (Click for more...) When considering triple therapy for COPD, select patients carefully 1/15/2019 10:03:39 AM When considering triple therapy for COPD, select patients carefully Tue, 01/15/2019 - 10:14 ehaberkorn@aph… Tue, 01/15/2019 - 10:03 A greater reduction in the risk of moderate or severe exacerbations and improvement in lung function and quality of life were observed in patients receiving triple inhalation therapy for chronic obstructive pulmonary disease (COPD) compared with dual inhalation therapy or monotherapy, according to results of a meta-analysis of 21 trials published in BMJ. (Click for more...) Congressmen to regulators: BMS-Celgene merger will stifle competition and raise drug prices 1/15/2019 9:58:05 AM U.S. Representatives Peter Welch and Francis Rooney are urging the Federal Trade Commission and Department of Justice to take a close look at Bristol-Myers' $74 billion purchase of Celgene. Why? Past pharma mergers have spawned price hikes that hurt consumers, the congressmen say. (Click for more...) Copay coupons help (a little) with CV drug adherence but not outcomes: study 1/15/2019 9:45:51 AM Copay coupons have long been a contentious topic in pharma. Now, a study has found that the coupons helped slightly with medication adherence—and moved doctors to prescribe costlier, more effective options—but didn't provide a benefit in health outcomes for patients who'd suffered a heart attack. (Click for more...) AHA says penalties as well as incentives are needed to face down 'persistent' drug shortages 1/15/2019 9:31:51 AM Responding to an FDA request for comment, the American Hospital Association, which represents 5,000 hospitals and 270,000 physicians, has crafted a lengthy list of suggestions for addressing drug shortages that include both the carrot and the stick. (Click for more...) Keytruda reduces risk of death compared to chemo 1/15/2019 7:38:43 AM Merck’s Keytruda has been found to reduce risk of death by 31% compared to chemotherapy, when used in previously treated patients with advanced esophageal or esophagogastric junction carcinoma, whose tumours express PD-L1. (Click for more...) ‘Ring-fence the prevention budget’ warns top Doctor 1/15/2019 7:29:42 AM Responding to the NHS’ long-term funding plan, experts have cautioned that for progress to be made, the funding must be protected for an appropriate time period. (Click for more...) European Commission approves Opdivo for advanced renal cell carcinoma 1/15/2019 7:12:47 AM The European Commission has approved Bristol-Myers Squibb's Opdivo in combination with low-dose Yervoy for first-line treatment of patients with intermediate and poor risk advanced renal cell carcinoma (RCC). (Click for more...) SMC OK's four meds for NHS use, including Roche's Perjeta 1/15/2019 7:07:02 AM The Scottish Medicines Consortium (SMC) has recommended four medicines - including Roche's breast cancer drug Perjeta - for use on the NHS. (Click for more...) FDA Announces Plans to Improve Approvals Process for Medical Devices 1/15/2019 2:33:40 AM In the pharmaceutical industry, safety protocols are rigorous. Clinical trials, a lengthy and intense part of the drug development process, are deemed absolutely crucial to ensuring the safety and efficacy of new drugs and therapies. There are also many regulations designed to make certain that high standards are maintained during the various trial phases. However, […] (Click for more...) Pharma and Biotech Firms Gather at the 37th Annual J.P. Morgan Healthcare Conference 1/15/2019 12:16:18 AM 2019 marks the 37th year of the J.P. Morgan Healthcare Conference, which has come to be one of the premiere annual events for companies involved in all aspects of the industry, from biotech start-ups to large healthcare service providers. Held in San Francisco at the very beginning of January, the conference often sets the tone […] (Click for more...) Calcium Chloride Injection 1/14/2019 7:00:00 PM Drug: Calcium Chloride Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Potassium Phosphate Injection 1/14/2019 7:00:00 PM Drug: Potassium Phosphate Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Sodium Bicarbonate Injection 1/14/2019 7:00:00 PM Drug: Sodium Bicarbonate Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Sodium Phosphate Injection 1/14/2019 7:00:00 PM Drug: Sodium Phosphate Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Thiamine Injection 1/14/2019 7:00:00 PM Drug: Thiamine Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Procainamide Hydrochloride Injection 1/14/2019 7:00:00 PM Drug: Procainamide Hydrochloride Injection, Revision Date: Tue, 15 Jan 2019 (Click for more...) Merck's Keytruda slashes death risk by 31% in esophageal cancer victory 1/14/2019 4:59:06 PM Back in November, Merck & Co. said its immuno-oncology star, Keytruda, had topped chemo at lengthening the lives of some esophageal cancer patients. Monday, it showed that the win was a sizable one. (Click for more...) CDC: Influenza has sickened about 7 million so far this season 1/14/2019 3:05:01 PM CDC: Influenza has sickened about 7 million so far this season Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Between 6.2 million and 7.3 million people in the United States have been sick with influenza so far this season, CDC reported Friday. According to new data, 2.9 million to 3.5 million people have visited the doctor because of influenza, and up to 83,500 people have been hospitalized because of influenza. CDC noted, "This is the first time these estimates—which cover the period from October 1, 2018 through January 5, 2019—are being provided during the flu season." The agency continues to recommend vaccination as the best way of reducing the risk of influenza and its complications. Individuals who are very ill or who are at high risk for serious complications from influenza and have influenza symptoms should see their health care provider early in their illness for possible treatment with an influenza antiviral medication. CDC also recommends common preventive actions to stop the spread of germs, such as washing your hands often with soap and water and, for those with influenza-like illness, staying home for at least 24 hours after their fever has ended. (Click for more...) Virtual repurposing can speed the discovery of new uses for existing drugs 1/14/2019 3:05:01 PM Virtual repurposing can speed the discovery of new uses for existing drugs Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Innovations in data analysis are overhauling the process of drug discovery, says Inga Peter, PhD, a professor of genetics and genomic sciences at the Icahn School of Medicine at Mount Sinai. For instance, emerging capabilities in biomedical informatics and machine learning help researchers evaluate larger quantities of data to identify common genetic links between diseases. Peter and her colleagues used this approach to uncover a possible link between Parkinson disease and Crohn disease and ulcerative colitis. Their search focused on a population at high risk for Crohn disease: those of Eastern European Jewish origin. A gene called leucine-rich repeat kinase 2 (LRRK2) was closely linked with Crohn disease, increasing the risk for the disease by 70%. Previously, LRRK2 had been linked to Parkinson disease. The link was confirmed by comparing the LRRK2 mutation with Crohn disease in patients with Parkinson disease in both Ashkenazi and non-Ashkenazi populations. The researchers compared the health data of more than 140,000 individuals with inflammatory bowel disease (IBD) to a control group of 720,000 people without IBD, and found that people with IBD were 28% more likely to have Parkinson disease than those without IBD. Separate health-data studies in Sweden, Denmark, and Taiwan confirmed the findings. (Click for more...) HIV viral load and transmissibility of HIV infection 1/14/2019 3:05:01 PM HIV viral load and transmissibility of HIV infection Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Robert W. Eisinger, PhD, Carl W. Dieffenbach, PhD, and Anthony S. Fauci, MD, from NIH's National Institute of Allergy and Infectious Diseases discuss the treatment, societal, and legal implications of the Undetectable = Untransmittable (U=U) initiative to combat HIV/AIDS. The program is based on the premise that patients with HIV who achieve and maintain an undetectable viral load after antiretroviral therapy (ART) cannot sexually transmit the virus to others. Prevention, in turn, works to control the spread of infection. The concept first surfaced more than a decade ago but initially did not gain wide acceptance because the science backing it lacked the rigor of randomized clinical trials. In the time since, the data has been generated to declare the concept scientifically sound. However, the validity of U = U hinges on people with HIV seeking out, initiating, and sticking to their ART regimens. According to the authors, that means administrators must find ways to motivate patients toward this behavior. From a societal perspective, they add, U = U will help eliminate feelings of fear and guilt that a person with HIV may be harming someone else, as well as stigma—outside and internalized—associated with the disease. Finally, the concept has legal implications in terms of the law, as criminal law is used to punish alleged, perceived, or potential HIV exposure of one person to another. (Click for more...) Issues Summit panelists talk hurdles to patient-facing care 1/14/2019 3:05:01 PM Issues Summit panelists talk hurdles to patient-facing care Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Efforts to improve patient-facing care in community-based pharmacy were discussed by an executive panel at the Drug Store News Industry Issues Summit in New York City in late November. "The cost of health care has just escalated to a point where consumers are now in much more control," said Dain Rusk, vice president of pharmacy at Publix Super Markets. "It's no longer just about patients going to their doctor; it’s about bringing health care to the consumer." Other panelists noted that pharmacists are working harder to deliver outstanding results in collaboration with key partners, but face obstacles in freeing themselves up for more face-to-face time with patients and in overcoming the constraints of traditional reimbursement models. "An important piece is transparency on how we get paid for the improved outcomes, and that we're providing value to our patients," said Rina Shah, vice president of pharmacy operations and specialty at Walgreens. "Currently, the targets continue to change and the measurements vary." Ryan Rumbarger, vice president of pharmacy operations at CVS Health, said that "cost and price transparency are what we hear most about from our patients. We're all doing different things to try to make prescription drug prices more transparent, and to lower out-of-pocket costs." (Click for more...) Pharmacists could dramatically reduce ER visits 1/14/2019 3:05:01 PM Pharmacists could dramatically reduce ER visits Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 A new study published in Research in Social and Administrative Pharmacy suggests that installing pharmacists with an expanded scope of practice in hospital emergency departments (ED) or community practices could drastically decrease ED crowds and free up more resources. Researchers from the University of Waterloo found that nearly 33% of non-urgent ED visits in Ontario, Canada, were for conditions that could potentially be managed by pharmacists with an expanded scope of practice. The researchers studied all Ontario hospital ED cases from 2010 to 2017 and determined what proportion of non-urgent or unnecessary visits could be managed by pharmacists working with an expanded scope. "Over the 7 years of the study period, we found that pharmacists with an expanded scope could potentially have managed nearly 1.5 million cases in Ontario," said Wasem Alsabbagh, a professor at the Waterloo School of Pharmacy. The most common ED cases that could be managed by a pharmacist included skin-related concerns such as dermatitis and other ailments including a cough or inflammation of the ear canal, nasal passages, and throat. (Click for more...) Samsung faces resistance from big pharma in the U.S. 1/14/2019 3:05:01 PM Samsung faces resistance from big pharma in the U.S. Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 The U.S. biologic-drug market has not been easy to break into for Samsung's drug-development arm, Samsung Bioepis Co. Its CEO, Christopher Ko, PhD, says existing companies are signing exclusive contracts and offering rebates to insurers, health care providers, and other payers. His company entered in the U.S. market in July 2017 with a biosimilar version of the rheumatoid-arthritis drug infliximab (Remicade—Johnson & Johnson). Another hurdle was convincing doctors and patients that less expensive biosimilars can work as well as the original, he says. U.S. regulators may soon approve Samsung's biosimilar of trastuzumab (Herceptin—Roche Holding AG), which would make the breast cancer treatment the company's second biosimilar in the United States. Meanwhile, regulatory uncertainties and lawsuits among drugmakers are affecting the uptake of biosimilars. But Ko is optimistic about a recent deal with the U.S. Department of Veterans of Affairs, where its rheumatoid-arthritis treatment will be supplied by partner Merck & Co. (Click for more...) AllianceRx Walgreens Prime earns specialty pharmacy reaccreditation 1/14/2019 3:05:01 PM AllianceRx Walgreens Prime earns specialty pharmacy reaccreditation Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 URAC has reaccredited AllianceRx Walgreens Prime for its specialty pharmacy services. In achieving this status, the specialty and home delivery pharmacy has demonstrated its comprehensive commitment to quality care, enhanced processes, and improved patient outcomes. The reaccreditation is effective until January 1, 2022. Joel Wright, CEO of AllianceRx Walgreens Prime said, "Last spring, our home delivery pharmacies received accreditation from URAC, and I'm proud to announce our specialty pharmacies were just awarded full reaccreditation. Receiving reaccreditation is affirmation of our teams' commitment to the highest standards of care for our patients." (Click for more...) J&J raises U.S. prices on around two dozen drugs 1/14/2019 3:05:01 PM J&J raises U.S. prices on around two dozen drugs Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 After many drugmakers increased prices earlier this month, Johnson & Johnson has followed suit, increasing U.S. prices on around two dozen prescription drugs. Data from Rx Savings Solutions showed that most of the increases were between 6% and 7%, and they affected some of the company's top-selling products, such as the psoriasis treatment ustekinbumab (Stelara). According to J&J, the average list price increase on its drugs will be 4.2% in 2019. The net price the company actually receives for its products is expected to decline, however, as drug companies negotiate rebates and discounts off the list price with payers. (Click for more...) Patients using crowdfunding to promote unproven alternative cancer treatments, study finds 1/14/2019 3:05:01 PM Patients using crowdfunding to promote unproven alternative cancer treatments, study finds Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 A study published in The Lancet Oncology suggests that when patients use crowdfunding for alternative cancer treatments, the practice promotes unproven therapies. Jeremy Snyder of Simon Fraser University and Timothy Caulfield of the University of Alberta searched the crowdfunding platform GoFundMe for medical campaigns, identifying 220 as of June 2018; of these, 85% were in the United States. The researchers said campaigns requested funds for such unproven cancer treatments as homeopathic treatments, dietary regimens, acupuncture, and cannabidiol. The study found that 38% of people used alternative treatments as complementary to traditional treatment, and almost 30% of campaigns were for people who opted not to undergo traditional treatment. Researchers added that individuals "often felt alternative treatments were a more natural alternative to 'synthetic medicines.'" In all, 4% of the studied campaigns did not include a rationale for seeking alternative cancer treatments, and 29% of campaigns made unsubstantiated, positive claims about the activity of alternative cancer treatments. The researchers stated, "Oncologists and other medical practitioners should be prepared to discuss these concerns with their patients. Cancer research agencies and patient support groups could raise the profile of these issues with public statements of concern around the role of crowdfunding in encouraging the use of unproven cancer treatments." (Click for more...) Shutdown exacerbates opioid crisis as doctors blocked from prescribing key medication 1/14/2019 3:05:01 PM Shutdown exacerbates opioid crisis as doctors blocked from prescribing key medication Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Sen. Charles Schumer (D-NY) on Sunday warned that the shutdown is making it harder to conquer the opioid crisis. Doctors seeking to prescribe buprenorphine are being blocked by the ongoing partial federal government shutdown, he noted. Physicians must get approval from DEA, but staff there are locked out. "Simply put, DEA, in many ways, holds the keys to accessing critical anti-opioid treatment drugs that New York City and Long Island patients and doctors need to combat this deadly scourge," Schumer said in a statement. (Click for more...) Louisiana moves ahead with subscription model to pay for hepatitis C drugs for thousands 1/14/2019 3:05:01 PM Louisiana moves ahead with subscription model to pay for hepatitis C drugs for thousands Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Louisiana is on track to become the first state to adopt a new method of obtaining normally pricey hepatitis C drugs. State officials report that Louisiana has begun the process of formally seeking a pharmaceutical partner for an innovative "subscription" model for obtaining treatments that cure hepatitis C. Under the current timeline, the state hopes to have a contract in place by July. The launch of a government "solicitation for offers" kicks off the process of establishing a formal partnership. The new proposal is being referred to as a subscription-based model. The state will take the money that it currently spends toward hepatitis C treatment in Medicaid and the prison system, and find a drugmaker that will agree to be paid that amount for unlimited access to the medication over a 5-year period. (Click for more...) OPDP enforcement letters in 2018: Numbers remain low 1/14/2019 3:05:01 PM OPDP enforcement letters in 2018: Numbers remain low Sun, 01/13/2019 - 19:00 cbaker_admin Mon, 01/14/2019 - 15:05 Last year, FDA's Office of Prescription Drug Promotion (OPDP) sent out two warning letters and five untitled letters. In 2017, there were just three warning letters and one untitled letter. The number of action letters sent by OPDP each year has declined since the late 1990s, when more than 100 letters were issued every year; however, 2017 and 2018 are only the second and third times when the office has sent less than 10 action letters. Last year, OPDP also released metrics on how well it initially reviewed promotional campaign information. "FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public's first impression of new drugs," OPDP said. According to the data, FDA regularly reviewed promotional materials within its 45-day window of the voluntary submission of this information. The office also receives complaints about potentially false or misleading promotions from health care providers, consumers, drug sponsors, and others, and OPDP aims to acknowledge receipt of those complaints within 30 calendar days. (Click for more...) New guidelines add latest evidence on managing opioid-induced constipation 1/14/2019 3:00:40 PM New guidelines add latest evidence on managing opioid-induced constipation Mon, 01/14/2019 - 15:05 caldridgeyoung… Mon, 01/14/2019 - 15:00 The American Gastroenterological Association (AGA) updated its guidelines on medical management of opioid-induced constipation (OIC), which were published last October in AGA’s Gastroenterology . Considering the climbing rate of opioid use in the (Click for more...) Can Amgen bone drug Evenity make a comeback? FDA, analysts aren't so sure 1/14/2019 11:45:14 AM Amgen osteoporosis candidate Evenity is trying to score an approval after cardiovascular red flags derailed it in mid-2017. But analysts aren’t so optimistic, and FDA review documents posted Monday suggest the drug has an uphill battle for approval. (Click for more...) Will Trump team with Democrats to tweak the latest pricing bills? Maybe, analyst says 1/14/2019 10:48:15 AM Already the Democrats in Congress are showing they're serious about tackling drug prices, not only with new bills, but a new name-and-shame investigation, too. But those bills are "flawed"—and likely to fail—unless Trump crosses the aisle. And as one analyst sees it, he just might. (Click for more...) Can Botox hang with CGRP in migraine? Allergan says yes; analysts are skeptical 1/14/2019 10:09:28 AM Last week, Allergan CEO Brent Saunders told investors that Botox “continues to remain very strong” in migraine despite the arrival of three drugs from the brand-new CGRP class. But exactly how strong? (Click for more...) Want to win over payers, pharma? Forget the 'me-too' drugs, CSL chief says 1/14/2019 9:56:04 AM If payers are looking askance at certain new drugs, there's good reason, CSL Chief Executive Paul Perreault figures. Pharma is too preoccupied with short-term growth, so it's going for the easier me-too route rather than focusing on "transformative" therapies. (Click for more...) 145 babies given expired polio vaccines in Chinese city—and there could be more 1/14/2019 5:13:35 AM Just months after a vaccine scandal made waves and undermined the public’s confidence in the country’s vaccine industry, 145 children in an eastern Chinese city were found to have received expired polio shots. (Click for more...) Enoxaparin Sodium Injection 1/13/2019 7:00:00 PM Drug: Enoxaparin Sodium Injection, Revision Date: Mon, 14 Jan 2019 (Click for more...) Folic Acid Injection 1/13/2019 7:00:00 PM Drug: Folic Acid Injection, Revision Date: Mon, 14 Jan 2019 (Click for more...) Secobarbital Capsules 1/13/2019 7:00:00 PM Drug: Secobarbital Capsules, Revision Date: Mon, 14 Jan 2019 (Click for more...) Pharma, consumer-style? New McCann Health CCO aims to inject fresh attitude 1/13/2019 11:01:29 AM In a first for pharma and healthcare agencies, McCann Health has hired a global creative chief, Matt Eastwood, directly from a large consumer agency. And he's promising to bring along consumer experience, big ideas and fresh thinking. (Click for more...) Drug overdoses among middle-aged women in U.S. soar 1/11/2019 12:05:01 PM Drug overdoses among middle-aged women in U.S. soar Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 CDC reported Thursday that the death rate from drug overdoses among women aged 30–64 years increased 260% from 1999 to 2017. Researchers said the number and rate of deaths involving antidepressants, benzodiazepines, cocaine, heroin, and synthetic opioids each increased during this time frame. In this age group, the rate of death involving synthetic opioids increased 1,643%, while the rate for heroin rose 915% and for benzodiazepines the rate jumped 830%. According to CDC, "Interventions to address the rise in drug overdose deaths include implementing the CDC Guideline for Prescribing Opioids for Chronic Pain, reviewing records of controlled substance prescribing (e.g., prescription drug monitoring programs, health insurance programs), and developing capacity of drug use disorder treatments and linkage to care, especially for middle-aged women with drug use disorders." (Click for more...) Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura 1/11/2019 12:05:01 PM Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Acquired thrombotic thrombocytopenic purpura (TTP) is characterized by unrestrained adhesion of von Willebrand factor multimers to platelets and microthrombosis, which leads to thrombocytopenia, hemolytic anemia, and tissue ischemia. Researchers wondered if supplementing usual treatment for TTP with caplacizumab—which interferes with von Willebrand factor, a key protein in hemostasis—might mitigate this effect. The 145 participants in the Phase III HERCULES study were randomized to caplacizumab or placebo during plasma exchange and the ensuing 30 days. The primary outcome was time to normalized platelet count. Patients receiving adjuvant therapy were 1.55 times as likely as controls to achieve the endpoint and did so within a shorter time frame. In addition, treatment with caplacizumab resulted in a lower rate of a composite of TTP-associated death, disease recurrence, or major thromboembolic event during the active treatment period. Moreover, the intervention was correlated with a lower incidence of TTP recurrence over the entire duration of the trial compared with placebo. A larger share of the caplacizumab patients experienced mucocutaneous bleeding, however. Despite the greater risk for this adverse event, investigators concluded that adding caplacizumab to standard care for TPP is viable and beneficial. (Click for more...) Hawaii, Connecticut and Maryland see influenza activity gains 1/11/2019 12:05:01 PM Hawaii, Connecticut and Maryland see influenza activity gains Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 For the week ending January 5, El Paso, TX (Las Cruces, NM); Lincoln & Hastings-Kearney, NE; and Omaha, NE, were the top three designated market areas (DMAs) in terms of influenza activity in the United States, according the Walgreens Flu Index. Nebraska, New Mexico, and Kentucky led the list of states with the most influenza activity, the index shows. The top DMAs with influenza activity gains were Bakersfield, CA; Honolulu, HI; and Richmond-Petersburg, VA. The top states with influenza activity gains for the week ending January 5 were Hawaii, Connecticut, and Maryland. (Click for more...) Use of HRT and risk of venous thromboembolism 1/11/2019 12:05:01 PM Use of HRT and risk of venous thromboembolism Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Research out of the United Kingdom examined the relationship between various types of hormone replacement therapy and the risk for venous thromboembolism. The University of Nottingham team relied on data from general practices, death certificates, and hospital records. The sample population of more than 80,000 women aged 40–79 years with confirmed venous thromboembolism was matched by age, general practice, and index date to more than 391,000 female controls. Investigators subsequently identified 5,795 of those patients and 21,670 of the controls as also having hormone replacement therapy (HRT)—oral therapy, most often—within 3 months of the index date. The exposure was correlated with significantly higher odds of developing venous thromboembolism compared with no HRT exposure. The finding was consistent for both estrogen-only treatments and combined formulations but not for transdermal preparations. Although oral HRT is the preferred method, the evidence suggests that transdermal treatment is the safest in terms of risk venous thromboembolism. (Click for more...) Facing legal action, insurer now will cover people taking HIV-prevention drug 1/11/2019 12:05:01 PM Facing legal action, insurer now will cover people taking HIV-prevention drug Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Mutual of Omaha has agreed not to deny insurance to people who use medications to prevent HIV infection, settling allegations of discrimination filed by the Massachusetts attorney general's office. The insurer also has settled a lawsuit brought by an unidentified gay man in Massachusetts who was turned down for long-term-care insurance after acknowledging that he took the HIV-prevention drug emtricitabine/tenofovir disoproxil fumarate (Truvada—Gilead Sciences). "Consumers looking to protect themselves from HIV transmission should not be excluded from buying insurance," Maura Healey, the attorney general of Massachusetts, said in a prepared statement. Mutual of Omaha admitted no wrongdoing in the settlements and will make a $25,000 payment to the state. The company became the focus of discrimination complaints after applicants, mostly gay men, said they were denied disability, long-term-care, or life insurance solely because they were taking Truvada to protect themselves from HIV. CDC urges men and women at risk for HIV infection to take the drug daily. Studies have shown it to be extremely effective at blocking the virus, and health insurers almost always cover the cost. Some gay men said that they stopped taking Truvada, potentially endangering themselves, simply to obtain insurance. (Click for more...) 'Marketers are having a field day' 1/11/2019 12:05:01 PM 'Marketers are having a field day' Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Doctors, drug companies, and government officials are growing increasingly concerned that the makers of the most advanced drug therapies are using scare tactics to ward off emerging generic versions of their products. FDA Commissioner Scott Gottlieb and others have warned that the companies that make costly name-brand biologic drugs are sowing doubt about the wisdom of switching to biosimilars—even though FDA has certified they are safe and effective. Biologics have led to breakthroughs against serious diseases, but they are hugely expensive. The campaign against those biosimilars could delay affordable access to a host of novel therapies, hurting patients and driving up health care costs. "I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion" about the safety and effectiveness of unbranded biologic drugs, Gottlieb said. The messages "can potentially undermine consumer confidence in biosimilars in ways that are untrue." He indicated FDA may take action if it determines a company is deliberately misleading the public about the safety of biologic copies, by issuing warning letters to the drugmakers involved. (Click for more...) Industry builds on FDA plans for expansion of national drug code 1/11/2019 12:05:01 PM Industry builds on FDA plans for expansion of national drug code Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 FDA's August 2018 notice announcing an expected need to expand the National Drug Code (NDC) format within 15 years has elicited a variety of industry feedback. Commenters cited concerns including struggles to meet deadlines from the Drug Supply Chain Security Act (DSCA), the link between NDC and the Globe Trade Item Number (GTIN), the amount of time and resources needed to make the transition, and unintended supply disruptions. Other commenters congratulated FDA for its efforts to engage stakeholders early as it considers different options for implementing a new NDC format, and several expressed support for one of FDA's four proposed approaches that would allow for harmonizing a standard configuration for all NDCs and converting existing NDCs with new leading zeros. The problem with transitioning to a new NDC format while working to comply with DSCA requirements relates to these already being implemented using the current format, which relies on 5-digit labeler codes. With FDA's proposal to begin issuing 6-digit labeler codes as it runs out of 5-digit labeler codes within the next 10–15 years, the NDC would be expanded from the current 10 to 11 digits. PhRMA senior directors Ryan Kaat and Olivia Shopshear called on FDA to delay announcing implementation of a new format until after a November 27, 2023 DSCSA deadline, citing the significant amount of time and resources needed to revise production and packaging systems. (Click for more...) Eli Lilly to start publishing list prices of drugs 1/11/2019 12:05:01 PM Eli Lilly to start publishing list prices of drugs Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Eli Lilly announced this week that by the end of February, it will post price information online for all of the drugs it advertises on television. The company recently began running a TV ad for dulaglutide (Trulicity), which directs viewers to a website or a telephone number where they can learn about the list price, average out-of-pocket costs, and patient assistance programs. In October, the Pharmaceutical Research and Manufacturers of America (PhRMA) released revised marketing principles, which require every TV ad from a PhRMA member that mentions a prescription drug by name to include a voiceover or text telling patients to go to a website where they can find pricing information. Lilly said it is the first company to adopt the revised principles. "We recognize that the U.S. health care system has asked Americans to pay more out-of-pocket—including for prescription medicines," said Lilly in a statement. "So people need new tools to help them." (Click for more...) Texas hospitals adapt existing technology to tackle opioid crisis 1/11/2019 12:05:01 PM Texas hospitals adapt existing technology to tackle opioid crisis Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 The Texas Hospital Association (THA) is providing health care providers with more data when they need it to combat the state's opioid epidemic. More than 85% of acute-care hospitals and health care systems in Texas are THA members, some of whom began using Smart Ribbon technology last year to provide physicians with just-in-time information as they treat patients. "Essentially, when a physician is in an encounter, it's an episode-context aware and patient-context aware tool," explains Fernando Martinez, PhD, senior vice president and chief digital officer with the THA. "This software tool pops up a ribbon that provides information to the provider about the patient around utilization, around cost, around a number of different physiometric values and things like that that are germane to treating the patient." Martinez says the technology, a joint effort with IllumiCare, essentially leverages existing data in a new way so that physicians would not have to exit their EMR when treating patients. THA hospitals are also using Collective Medical Technologies to recognize trends in how people seek opioid analgesics. The THA says about 130 hospitals in Texas are now using the technologies to instruct patients about opioid misuse. (Click for more...) Sen. Collins presses HHS to reform drug rebate system 1/11/2019 12:05:01 PM Sen. Collins presses HHS to reform drug rebate system Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Sen. Susan Collins (R-ME) has asked HHS to take action on the Trump administration’s pledge to change drug rebates, saying legislation may be necessary to reform the system. In a letter sent Wednesday, Collins, who chairs the Senate Special Committee on Aging, cited recent reports that more than three dozen pharmaceutical companies raised the price of hundreds of drugs January 1. Such increases "are shocking, but they are unfortunately not unusual, nor are they unexpected," Collins wrote in her letter. While consumers might pay less after rebates, discounts and insurance payments, "the opacity of these financial interactions” in the supply chain “conceal incentives that distort the pharmaceutical market," the letter said. Drugmakers have said they raise prices in conjunction with rebates, which they must give to PBMs in order to be placed on formularies. An HHS spokeswoman confirmed the agency received the letter and said in a statement that HHS Secretary Alex Azar has "made it clear that every actor—from manufacturers to benefit managers—involved in the current market is benefiting from ever higher prices—except patients." (Click for more...) Minnesota could create repository for unused prescription drugs 1/11/2019 12:05:01 PM Minnesota could create repository for unused prescription drugs Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 A bill before the Minnesota state legislature would create a repository for unused prescription medications. Currently, many drugs go to waste when patients are unable to use them, if their drug regimen changes or the patient dies. Often, the unused drugs are flushed down the toilet. According to Patti Cullen, president and CEO of Care Provider of Minnesota, which has 365 long-term care facilities as members, an estimated 29 tons of drugs are wasted in Minnesota each year, costing $16 million. Her organization supports a repository, where unused, unopened, and not tampered with medical products could be donated and dispensed to other patients for free, or at a very low cost. "It would be far, far less expensive for people to go through this program than buying a medication that might be $100—even $200 or more," said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. While lawmakers approved a repository many years ago, Wiberg noted that it only included a few cancer drugs, so many care facilities did not participate. If the new measure passes, there could be one central repository, with a number of satellites located around the state. A total of 21 states have active prescription drug repositories at present. (Click for more...) New laws to combat opioid abuse are taking effect in Tennessee 1/11/2019 12:05:01 PM New laws to combat opioid abuse are taking effect in Tennessee Thu, 01/10/2019 - 19:00 cbaker_admin Fri, 01/11/2019 - 12:05 Tennessee has passed several new laws to combat opioid abuse. One of the new laws requires any opioid prescription to be issued electronically, which will help prevent fake prescriptions. The law, which is one of 12 backed by TN Together, an initiative aimed at fighting opioid addiction, requires the name, address, and telephone number of the physician on the electronic prescription. The deadline to comply is July 2020; however, doctors in rural areas are exempt since they may not have the technology in place to transmit electronically to a pharmacy. In addition, the state has passed a law that limits first time opioid prescriptions, allowing pharmacists to only fill the prescription for half the days it is written for. The state also passed a law that requires the Tennessee Department of Health to have a hotline to report potential opioid abuse. (Click for more...) Pick your post-JPM buzz: Pfizer eyes Amarin, Biogen shops anyone with 'multiple' phase 3 drugs 1/11/2019 11:28:43 AM The dealing has just begun. Often, M&A that took shape at the J.P. Morgan Healthcare Conference materializes later in the year, and some recent buzz puts Pfizer and Biogen at the center of potential takeovers. (Click for more...) Teva shells out $135M to wrap Illinois AG's Medicaid pricing fraud suit 1/11/2019 11:14:37 AM Fourteen years after Illlinois' attorney general accused Teva of defrauding Medicaid with inflated pricing, the company has settled for $135 million. (Click for more...) Want to buy Clovis? Step up. ‘Everybody knows where to find me,’ CEO says 1/11/2019 10:07:26 AM Shortly after GlaxoSmithKline bought PARP-inhibitor innovator Tesaro in early December, analysts started buzzing that Clovis Oncology could be the next PARP player to get bought. Now Clovis CEO Patrick Mahaffy is making it clear he’s ready to deal. (Click for more...) First its CEO tells pharma to watch it on pricing—and then Johnson & Johnson raises them 1/11/2019 9:24:32 AM Johnson & Johnson CEO Alex Gorsky said this week the pharma industry needs to police itself on pricing or risk a real crackdown. Days later, his own company hiked the sticker prices on about two dozen drugs, including some top sellers. (Click for more...) The 54th Van Liere Research Conference now accepting abstracts for posters 1/11/2019 12:00:00 AM Now accepting abstracts for the poster session of the 54th Van Liere Research Conference, which will be held March 21 and 22 at the WVU Health Sciences Center. Deadline to submit is Feb.15. (Click for more...) Quinidine Gluconate Injection 1/10/2019 7:00:00 PM Drug: Quinidine Gluconate Injection, Revision Date: Fri, 11 Jan 2019 (Click for more...) Valganciclovir HCl Oral Powder for Solution 1/10/2019 7:00:00 PM Drug: Valganciclovir HCl Oral Powder for Solution, Revision Date: Fri, 11 Jan 2019 (Click for more...) The future of FDA's electronic safety surveillance 1/10/2019 11:05:01 AM The future of FDA's electronic safety surveillance Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 FDA outlined on Wednesday the steps it is taking to enhance the Sentinel System, the agency's electronic system for monitoring the safety of FDA-approved drugs and other medical products. First launched as a pilot a decade ago, Sentinel has become a key part of FDA's safety monitoring processes, according to FDA Commissioner Scott Gottlieb, MD, and Gerald Dal Pan, MD, MHS, director of FDA's Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research. They note that a new 5-year strategy "envisions a more robust Sentinel System which operates as a transformative national resource. The data and scientific resources will function as a multi-purpose center for evidence generation with the potential to be used by more stakeholders and inform all aspects of health care decision-making." To achieve this, FDA has set five strategic goals it hopes to reach by 2023: Enhance and expand the Sentinel System's foundation, including data, infrastructure, operations and technology; augment Sentinel's safety analysis capabilities using advances in data science and signal detection; use the system to accelerate access to and broaden the use of real world data for real world evidence; broaden the system's ecosystem of stakeholders to pursue the vision of a national resource; and disseminate knowledge and advance regulatory science to encourage innovation and meet the agency's scientific needs. "The cumulative impact of all five aims of this new plan will be substantial," write Gottlieb and Dal Pan. "It will allow stakeholders to continually discover new approaches to growing the Sentinel System's capabilities for the next 5 years and beyond." (Click for more...) OTC monograph reform passes House 1/10/2019 11:05:01 AM OTC monograph reform passes House Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 The House of Representatives on Tuesday passed a package of bills that includes the OTC Monograph Safety, Innovation and Reform Act aimed at modernizing the OTC monograph process. Industry officials point out the current monograph system relies on notice and comment rulemaking, which has become increasingly slow and unresponsive as a process. The new legislation includes reforms that would speed up the process of decision-making, provide FDA with funding and staff for OTC-related work, and build an information technology infrastructure. It also would improve communication and transparency between regulators and manufacturers by creating a streamlined regulatory path for review of innovations within the OTC monograph system, as well as enable FDA to quickly address emerging issues due to labeling and safety. (Click for more...) Day 19 of the shutdown: FDA shifts user fee funds to postmarket surveillance 1/10/2019 11:05:01 AM Day 19 of the shutdown: FDA shifts user fee funds to postmarket surveillance Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 In response to the ongoing partial government shutdown, FDA is now shuffling funds around to try to better monitor pharmaceuticals rather than to work on drug applications. There may be more shifts coming with regard to how user fee funding is allocated. More than 7,000 FDA staff, or 41% of the agency, have been furloughed because of the shutdown, while the remaining 10,344 have been retained, although those numbers may shift if FDA runs out of prescription drug user fee money. FDA Commissioner Scott Gottlieb said this week at the J.P. Morgan biotech conference that the medical device user fee funds have 2-3 months left, while the generic drug user fee funds have about 1 month left before running dry. "We're systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can. Our consumer protection role is our most critical mission. The functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances," Gottlieb said. (Click for more...) Guideline group turns gaze to opioid epidemic 1/10/2019 11:05:01 AM Guideline group turns gaze to opioid epidemic Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 The United States Preventive Services Task Force (USPSTF), which routinely draws up guidelines for disease prevention, has drafted a plan for research to identify evidence-based strategies that could lower the likelihood of addiction developing out of opioid prescriptions. The draft is open for public comment until mid-January. "This is a new preventive service we’re looking at," said Alex Krist, MD, a professor of family medicine at Virginia Commonwealth University and USPSTF vice-chair. "And we’re proposing to evaluate evidence around that preventive service. We’re looking for public input as we want to make sure we’re looking at the right kinds of evidence." The draft focuses on strategies that can be implemented in primary care settings to reach teens and adults with short-term or chronic pain who are not currently using opioids. The panel hopes to settle on a list of interventions that can then be researched for evidence of success. Special attention would be focused on groups believed to be particularly vulnerable, such as those with mental health problems along with pain, and those with prior histories of substance use disorders. (Click for more...) As Congress returns, lawmakers rush to detail drug-pricing agendas 1/10/2019 11:05:01 AM As Congress returns, lawmakers rush to detail drug-pricing agendas Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Sen. Chuck Grassley (R-IA), the new chair of the Senate Finance Committee, has attached his name to a trio of bills meant to lower drug costs, many of which have stalled in past sessions but that now enjoy renewed enthusiasm. One is a Grassley proposal with Sen. Amy Klobuchar (D-MN) that would allow Americans to import drugs from Canada for personal use. Grassley said Wednesday that he would bring back two other bills on the topic with Democrats: the CREATES Act, which aims to crack down on anticompetitive behavior from brand-name manufacturers, and a bill to ban the practice of "pay-for-delay," when companies pay generic manufacturers to delay production of off-patent drugs, as two other top priorities. Sen. Bernie Sanders (I-VT) is set to unveil his own drug pricing proposals on Thursday, one of which is conceptually similar to a Trump administration international reference pricing proposal. Sanders' version includes a provision that could strip drug companies of exclusive licenses if negotiations stall. In a Republican-controlled Senate, many of the more ambitious pieces of legislation are unlikely to become law, but as the White House continues to agitate on drug costs and with Democrats in control of the House of Representatives, many on Capitol Hill believe both parties have incentive to pass legislation in the next 2 years. (Click for more...) New York tackles 'largest measles outbreak' in state's recent history as cases spike globally 1/10/2019 11:05:01 AM New York tackles 'largest measles outbreak' in state's recent history as cases spike globally Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Since an outbreak of measles emerged in New York in September, the disease has been diagnosed in at least 112 people across Rockland and Orange counties and at least 55 in New York City, according to data from the state government and city health departments. The outbreak emerged after some children were infected on a visit to Israel in September, particularly affecting Orthodox Jewish communities, the New York City Health Department said. As of January 8, in New York City alone, "we have 55 cases confirmed in Brooklyn," said Jane Zucker, MD, MSc, assistant commissioner for the Bureau of Immunization at the NYC Health Department. Nationwide, the second-highest number of measles diagnoses occurred in 2018 after more than two decades, with 273 cases. (Click for more...) Effect of linagliptin vs. placebo on major CV events in high-risk adults with type 2 diabetes 1/10/2019 11:05:01 AM Effect of linagliptin vs. placebo on major CV events in high-risk adults with type 2 diabetes Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Evidence suggests that dipeptidyl peptidase 4 (DPP-4) inhibitors have a cardioprotective effect in type 2 diabetes; however, studies have been largely devoid of patients at high risk for cardiovascular (CV) events and kidney complications. In response, researchers recruited nearly 7,000 men and women matching this profile for the multinational CARMELINA trial. All participants received routine care plus linagliptin or placebo, depending on their randomization assignment. The primary outcome—a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke—occurred at a rate of 12.4% for those treated with the DPP-4 inhibitor and 12.1% for those receiving standard care over a median followup period of 2.2 years. The secondary outcome—time to first occurrence of adjudicated death due to kidney failure, end-stage renal disease, or decline in epidermal growth factor receptor of 40% or more from baseline—affected 9.4% of the linagliptin group and 8.8% of the controls. Based on the findings, the investigators concluded that usual care plus linagliptin is noninferior to usual care plus placebo in terms of risk of major CV events in individuals with type 2 diabetes. (Click for more...) Low-dose intracoronary alteplase during primary PCI on microvascular obstruction on patients with acute MI 1/10/2019 11:05:01 AM Low-dose intracoronary alteplase during primary PCI on microvascular obstruction on patients with acute MI Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Investigators explored the potential of a new strategy in patients undergoing primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI). Microvascular obstruction is common in this patient population and known to produce unfavorable outcomes, but the U.K. research team wondered if the risk could be lowered through adjunctive fibrinolytic therapy with low-dose intracoronary alteplase. Their treatment protocol called for infusion early during the procedure—i.e., after reperfusion of the affected coronary artery but before stent implant. The 440 participants in the multisite study were equally randomized to 10 mg of alteplase, 20 mg of alteplase, or placebo. The primary endpoint was the extent of microvascular obstruction in the 20 mg alteplase group vs. the control patients. Based on magnetic resonance imaging, microvascular obstruction was 3.5% in the former group and 2.3% in the latter group. The difference did not meet the parameters for statistical significance, and the investigators subsequently do not support the use of adjunctive fibrinolytic therapy with low-dose intracoronary alteplase in this setting. (Click for more...) Government shutdown stops FDA food safety inspections 1/10/2019 11:05:01 AM Government shutdown stops FDA food safety inspections Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Amid the ongoing federal government shutdown, FDA has stopped inspecting most domestic food production facilities. While some of the agency's work—such as drug approvals and inspections of drug-producing facilities—is covered by user fees, a great deal of the agency's budget is specifically appropriated by Congress, so it is on hold. About 41% of FDA's 17,000 personnel are furloughed. FDA Commissioner Scott Gottlieb says he hopes to resume inspections of high-risk domestic facilities, which would require calling some employees back to work without pay. "For me to do that, it would require calling back about 10% of our inspection force," he said. Facilities where the most urgent inspections would be needed are those where there have already been safety issues, followed by those that are more prone to contamination. Foreign food inspections have continued, close to normal, because they are deemed so important. (Click for more...) Biotech proposes paying for pricey drugs by installment 1/10/2019 11:05:01 AM Biotech proposes paying for pricey drugs by installment Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Massachusetts biotech Bluebird Bio Inc. is developing plans to sell its first gene-replacement therapy (LentiGlobin) on a 5-year installment plan, with each annual payment conditional on the treatment's continued effectiveness. The company will not disclose how much it intends to charge for the therapy, which aims to treat a rare inherited blood disease called beta thalassemia. But the price will be below $2.1 million, which Bluebird estimates is the drug's "intrinsic value" to patients, including improvements in quality and length of life, Bluebird CEO Nick Leschly said in an interview. With Bluebird's pricing strategy, the company would receive as little as 20% of the product's total cost upfront and put the remaining 80% "at risk" of nonpayment. Each following year, the insurer would pay down another 20%, but only if the treatment meets certain criteria. A handful of drug makers and health insurers have been considering such an approach as a solution to the high prices of emerging treatments. Bluebird could be one of the first to put payment by installment into effect; but it faces challenges in implementing the payment model, Leschly says, such as ensuring it will get paid if patients switch jobs or insurance carriers. (Click for more...) Effect of medication copayment vouchers on P2Y12 inhibitor use and MACE among patients with MI 1/10/2019 11:05:01 AM Effect of medication copayment vouchers on P2Y12 inhibitor use and MACE among patients with MI Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Researchers for the ARTEMIS trial sought to determine the effect of vouchers to cover copayment costs for P2Y12 inhibitors on medication persistence and major adverse cardiovascular events (MACE) among patients with acute myocardial infarction (MI). Data show that post-MI, 30%–60% of patients do not complete a 1-year course of treatment with P2Y12 inhibitors. The cluster randomized clinical trial included 301 hospitals that enrolled about 11,000 adults with acute MI. Hospitals randomized to the intervention gave patients copayment vouchers for clopidogrel or ticagrelor for 1 year, with the median value of the vouchers $137 for a 30-day supply. Hospitals that were randomized to usual care did not provide vouchers. At 1 year, patient-reported persistence with P2Y12 inhibitors was higher in the intervention group compared with the control group, with rates of 87% vs. 83.8%. According to the researchers, however, there was no significant difference in MACE between the two groups at that point. (Click for more...) Extreme temperatures may pose risks to some mail-order meds 1/10/2019 11:05:01 AM Extreme temperatures may pose risks to some mail-order meds Wed, 01/09/2019 - 19:00 cbaker_admin Thu, 01/10/2019 - 11:05 Mail-order prescriptions accounted for almost 25% of total U.S. spending on prescriptions (before rebates and discounts) as of 2016, a report from IQVIA's Institute for Human Data Science shows. While many prescription bottles have labels stating, "Store at room temperature" or "Keep refrigerated," drugs delivered by mail may sit outside for hours. Lead pharmacist at the OptumRX warehouse Alysia Heller said the warehouse has a system to account for weather. "If there's an extreme heat situation where a product is going into 100-plus degree weather, the system will tell the technician to add an extra ice pack," Heller said, "because we've monitored the zip code and the weather in that area." However, at OptumRX and across the industry, that level of temperature-controlled shipping is usually reserved only for a limited number of prescriptions. Standard, room temperature drugs are usually just sent in bubble mailers. When asked about temperature concerns and the safety of drugs sent by mail, the Pharmaceutical Care Management Association wrote in a statement: "Mail-service pharmacies adhere to all Food and Drug Administration rules, ship those prescription medications that may be adversely affected by extreme heat in refrigerated packaging, and notify patients to make sure those packages have been delivered properly." (Click for more...) Bupivacaine Injection 1/9/2019 7:00:00 PM Drug: Bupivacaine Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Busulfan Injection 1/9/2019 7:00:00 PM Drug: Busulfan Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Hepatitis A Virus Vaccine Inactivated 1/9/2019 7:00:00 PM Drug: Hepatitis A Virus Vaccine Inactivated, Revision Date: Thu, 10 Jan 2019 (Click for more...) Hydromorphone Hydrochloride Injection 1/9/2019 7:00:00 PM Drug: Hydromorphone Hydrochloride Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Indomethacin Capsules 1/9/2019 7:00:00 PM Drug: Indomethacin Capsules, Revision Date: Thu, 10 Jan 2019 (Click for more...) Iopamidol Injection 1/9/2019 7:00:00 PM Drug: Iopamidol Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Labetalol Injection 1/9/2019 7:00:00 PM Drug: Labetalol Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Leucovorin Calcium Injection 1/9/2019 7:00:00 PM Drug: Leucovorin Calcium Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Lidocaine Injection 1/9/2019 7:00:00 PM Drug: Lidocaine Injection, Revision Date: Thu, 10 Jan 2019 (Click for more...) Sun Pharmaceutical Industries issues recall of vecuronium bromide for injection 1/9/2019 10:05:01 AM Sun Pharmaceutical Industries issues recall of vecuronium bromide for injection Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 Sun Pharmaceutical Industries announced a voluntary recall of three lots of vecuronium bromide for injection, 10 mg (lyophilized powder) and one lot of vecuronium bromide for injection, 20 mg (lyophilized powder). The recall is being undertaken following the discovery of particulate matter that has been identified as glass. To date, the company has received no reports of adverse events related to the recall. The product, which should be administered by or under the supervision of experienced clinicians and must be reconstituted prior to use, was distributed nationwide to wholesale customers and medical facilities. (Click for more...) What to consider when switching to a mail-order pharmacy 1/9/2019 10:05:01 AM What to consider when switching to a mail-order pharmacy Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 Health insurers are increasingly steering customers toward a mail-order pharmacy. "It's all about convenience. You don't have to leave home or wait in long lines. Plus, it's easy to get all your medication refilled and shipped at one time and is usually more affordable," says Mohamed Jalloh, a pharmacist and the official spokesman for APhA. Although automation has taken over many tasks, thousands of pharmacists and pharmacy technicians work at mail-order outlets. "Whether it's a store or mail order, a licensed pharmacist physically checks every prescription before it goes to the recipient. It's the law," says Albert Wertheimer, professor of social and administrative pharmacy at Touro College of Pharmacy in New York City. Kirk Nilson, senior vice president of home delivery operations for OptumRx, describes how the system ensures accuracy. Medications are sorted and scanned using high-resolution and high-speed scanners. All information is verified by pharmacists and undergoes up to 16 fulfillment quality checks. In addition to often passing on savings to customers in prescription costs, mail-order pharmacies offer free shipping as well as an automatic refill option. However, if a physician prescribes an antibiotic or antiviral that needs to be started immediately, it is best to head to a local pharmacy. Also, few mail-order pharmacies produce customized, made-to-order medicines, so people taking a compounded medication probably need a local pharmacy. (Click for more...) More than 1 in 10 U.S. adults has a food allergy, study finds 1/9/2019 10:05:01 AM More than 1 in 10 U.S. adults has a food allergy, study finds Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 More than 10% of U.S. adults have at least one food allergy, according to a new study in JAMA Network Open. Comparatively, between 4% and 6% of American children are affected by food allergies, CDC reports. "We think about it in children, but we don't put enough emphasis in it in adults," said Ruchi Gupta, MD, one of the study's authors, adding that "we need to put more effort into understanding what is happening in the adult population." The most common allergens for adults were shellfish, peanuts, milk, tree nuts, and fin fish. Given that shellfish and peanut allergies are rarely outgrown, "this finding suggests that the population-level burden of food allergy is likely to increase in the future, absent widespread implementation of effective prevention efforts and/or therapies," the study says. Nearly one-half of the adults with allergies were allergic to more than one food item. Meanwhile, 48% developed at least one allergy in adulthood, 26.9% developed allergies only in adulthood, and 52% developed an allergy before age 18 years. Of adults with allergies, about one-quarter were prescribed epinephrine and more than one-third had visited an emergency department at least once because of their food allergy. Many respondents believe they have a food allergy but have not been officially diagnosed, which researchers said highlights the importance of visiting a medical professional about allergy concerns. (Click for more...) Vermont study shows savings from Canadian drugs 1/9/2019 10:05:01 AM Vermont study shows savings from Canadian drugs Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 A new report from the Vermont Agency of Human Services concludes that a plan to import prescription drugs from Canada could save insurers in the state millions of dollars a year. The report also outlines a plan for licensing and safety in a prescription importation system. A key question not answered in the report is what the state's costs for starting and operating such a system would be. In last year's session, the state legislature approved S. 175, which calls for the state to import less expensive prescription drugs from Canada. The bill was signed by Gov. Phil Scott in May, but there is no guarantee the program will happen. Canadian drug importation requires special approval from the secretary of HHS, and it has not been clear whether importing prescription drugs would save money or how such a program would operate. One finding from the report is that two insurers in Vermont—Blue Cross and Blue Shield of Vermont, and MVP Health Care—could save between $1 million and $5 million a year by importing drugs from Canada. To reach that conclusion, researchers compared U.S. and Canadian prices for 17 importation-eligible drugs that the insurers considered "top spend" during the second quarter of 2018. Even with a 45% markup on the Canadian drugs, the report noted the insurers could save $2.61–$2.82 per member each month. The study included only private insurers, omitting the state's Medicaid program, because the Department of Vermont Health Access "determined that drug importation from Canada would not provide net savings to the state or individuals because Medicaid's existing prescription drug rebate program already yields substantial savings," according to the report. (Click for more...) Prescription drug spending higher at 340B hospitals, study finds 1/9/2019 10:05:01 AM Prescription drug spending higher at 340B hospitals, study finds Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 A new study indicates that per-patient prescription drug spending increased by 32.4% at hospitals in their first year of enrollment in the 340B Drug Pricing Program as compared with the year prior. In contrast, there was a 13.4% increase in prescription drug spending per patient at non-340B hospitals during the same time, according to the study by the Berkeley Research Group (BRG) funded by the Pharmaceutical Research and Manufacturers of America. In addition, the per-patient, per-date-of-service drug spending cost rose by 20.6% for 340B hospitals, compared with a decrease of 4.7% during the same period among non-340B hospitals. Policymakers intended for the 340B program's discounts on certain outpatient drugs to help hospitals that treat more low-income and uninsured patients "stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services," according to the Health Resources & Services Administration (HRSA). Entities covered by 340B have purchased more than $19 billion in drugs at the 340B discounted price, representing 114% growth since 2014. For the study, researchers analyzed Medicare fee-for-service hospital outpatient claims and HRSA Office of Pharmacy Affairs data for 379 disproportionate share hospitals enrolling in the 340B program between January 2009 and January 2016. (Click for more...) CDER outlines drug safety priorities 1/9/2019 10:05:01 AM CDER outlines drug safety priorities Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 A new report from FDA's Center for Drug Evaluation and Research (CDER) discusses drug safety priorities from 2018. The report noted that the valsartan contamination situation demonstrates how the safety checks work well. "FDA continues to investigate and test all ARBs [angiotensin II receptor blockers] for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities at above-acceptable levels," the agency said. In a blog post Tuesday, CDER Director Janet Woodcock said, "We'll be sharing more soon about our plans for leveraging the possibilities for the Sentinel System to capture real-world data to help in our safety surveillance framework." The agency also outlined its safety surveillance for generic drugs, including clinical safety surveillance. Woodcock also noted that FDA has "taken many steps to strengthen safety measures for compounded drugs, especially in light of the 2012 outbreak of fungal meningitis associated with contaminated compounded drugs." (Click for more...) Arkansas issues first licenses to PBMs 1/9/2019 10:05:01 AM Arkansas issues first licenses to PBMs Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 The Arkansas Insurance Department now licenses and oversees PBMs after pharmacists blamed them for drastic cuts to their reimbursement rates last year. Lawmakers crafted Act 3 during the 2018 special session. The insurance department issued its first PBM licenses this week to Aetna Pharmacy Management and CVS Caremark. It also gave a 60-day conditional license to OptumRX, pending the department's completion of its application. John Vinson, a pharmacists and the COO of the Arkansas Pharmacists Association, said he is excited the process is on time, but the issue is still a work in progress. "We felt like there was no market last year, that the market was broken," Vinson said. "We have some hope now that there will be the ability to have a more fair market and a referee on the playing field at least in Arkansas." Vinson said spread pricing is not technically prohibited, but the new law makes the mandated reporting on it more transparent and therefore less desirable to do. "Our understanding is the spread pricing has been eliminated so it should make it easier for patients to receive services and taxpayers to not be overcharged for administrative fees that they don't understand, to be honest with you, because they're opaque," Vinson said. "We like transparency and simplicity rather than complexity." (Click for more...) Ohio governor signs epinephrine bill into law 1/9/2019 10:05:01 AM Ohio governor signs epinephrine bill into law Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 Gov. John Kasich of Ohio signed into law this week a measure that permits pharmacists to substitute a generic epinephrine auto-injector for a prescribed, brand-name epinephrine auto-injector. The Epinephrine Accessibility Act, sponsored by state Rep. Derek Merrin (R-Monclova Township), had been in the works for close to 2 years. "By relaxing restrictive barriers, pharmacists will be empowered to seamlessly ensure patients are provided less expensive epinephrine auto-injectors," Merrin explained. "The legislation makes it easier for EpiPen competitors to compete, which will ultimately lead to lower costs." According to the Ohio Pharmacists Association, the bill also permits pharmacists to dispense epinephrine auto-injectors to adults without a prescription, after the pharmacist has established that the individual has already received an initial epinephrine prescription. The bill will become law 91 days after it is filed with the Secretary of State's Office. (Click for more...) CVS Health's Merlo touts Aetna integration, opening of concept store 1/9/2019 10:05:01 AM CVS Health's Merlo touts Aetna integration, opening of concept store Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 Speaking to investors at the 37th Annual J.P. Morgan Healthcare Conference Tuesday, CVS Health president and CEO Larry Merlo said the company is launching a specialized program to help support Aetna members being treated for cardiovascular disease to prevent avoidable hospital readmissions. "We are also piloting a program that leverages CVS pharmacists to provide face-to-face interactions and educate Aetna members on the available care management programs, as well provide patient-specific strategies to migrate the risk of nonadherence, side effects or gaps in care," Merlo said. He added that while it has only been 6 weeks since CVS closed its merger with Aetna, "we are absolutely off and running. We are opening a series of health care concept stores, which will be a testing ground for a new retail engagement model that brings health care services to consumers in a more convenient and accessible and consumer-focused manner. As we pilot the new program and service offerings, we will identify the solutions that are most effective and scalable, and roll them more broadly across our footprint." In February, CVS Health is opening its first concept store in Houston. Among some of the services that will be tested are new health-and-wellness categories in the front of the store and enhanced personalized prescription services in the pharmacy. (Click for more...) U.S. cancer death rate hits milestone: 25 years of decline 1/9/2019 10:05:01 AM U.S. cancer death rate hits milestone: 25 years of decline Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 The mortality rate from cancer in the United States has been declining for at least 25 years, the American Cancer Society (ACS) reported Tuesday. Experts note the positive effect of advances in early detection and treatment, and lower smoking rates have led to fewer deaths. Still, the report noted that obesity-related cancer deaths are increasing and deaths from prostate cancer have stopped decreasing. The ACS predicts there will be more than 1.7 million new cancer cases and more than 600,000 cancer-related deaths in the United States this year. According to the report, the mortality rate for cancer dropped 27% between 1991 and 2016, due in large part to a decline in the death rate from lung cancer. (Click for more...) Perioperative glucose control in patients with diabetes undergoing elective surgery 1/9/2019 10:05:01 AM Perioperative glucose control in patients with diabetes undergoing elective surgery Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 Effective management of hyperglycemia in the perioperative setting is necessary for achieving favorable outcomes in diabetic patients, such as a shorter hospital stay, and avoiding unfavorable events, such as sepsis and stroke. While comprehensive guidelines have not been developed, Mayo Clinic researchers say the approach used at their institution has produced good results. As a starting point, clinicians make the call to postpone elective surgery if the patient's blood glucose level is too high during the preoperative assessment. If surgery moves forward, patients can continue all medications until the morning of their operation—which should be scheduled as early as possible to minimize fasting. That morning, insulin doses may be adjusted based on whether the patient has type 1 or type 2 disease and what kind of insulin they are taking. During surgery, meanwhile, it is important not to be overly aggressive with glucose control—which could inadvertently cause hypoglycemia or other harms. In order to find a balance, clinicians can turn to subcutaneous supplemental doses of rapid-acting insulin every 2 hours or I.V. insulin infusion with blood glucose monitoring every 1–2 hours. Also, for relatively brief procedures, patients who can self-manage could be good candidates for continuous subcutaneous insulin infusion via insulin pump. While in recovery, the patient's glucose levels should be checked again, and I.V. insulin infusion should continue—or be initiated in cases where subcutaneous insulin injections have been inadequate. (Click for more...) Combined dextromethorphan and quinidine in patients with dementia or Parkinson Disease 1/9/2019 10:05:01 AM Combined dextromethorphan and quinidine in patients with dementia or Parkinson Disease Tue, 01/08/2019 - 19:00 cbaker_admin Wed, 01/09/2019 - 10:05 FDA's 2010 approval of dextromethorphan hydrobromide plus quinidine sulfate to treat pseudobulbar affect was based on clinical evidence of benefit in patients with multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). In practice, however, physicians may be prescribing the combination therapy for people with other conditions. To learn more, researchers from Harvard Medical School analyzed prescribing patterns among patients in two commercial insurance databases. They identified 12,858 people who filled a prescription for dextromethorphan–quinidine during 2011–16, but only 6.8% were diagnosed with ALS and just 8.4% had MS. Patients with dementia and/or Parkinson disease, meanwhile, accounted for 57% of dextromethorphan–quinidine users. Additionally, although the therapy is contraindicated for those with a history of heart failure, 13.3% of the patients fell into that category. Using data from Medicare Part D, the Harvard team also determined that the number of patients prescribed dextromethorphan–quinidine surged from 3,296 at the start of the study period to 50,402 by the end. Spending on the medication over the same time jumped from $3.9 million to $200.4 million, according to CMS. (Click for more...) Ampicillin Sodium and Sulbactam Sodium Injection 1/8/2019 7:00:00 PM Drug: Ampicillin Sodium and Sulbactam Sodium Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Atropine Ophthalmic Solution 1/8/2019 7:00:00 PM Drug: Atropine Ophthalmic Solution, Revision Date: Wed, 09 Jan 2019 (Click for more...) Benztropine Mesylate Injection 1/8/2019 7:00:00 PM Drug: Benztropine Mesylate Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Bumetanide Injection 1/8/2019 7:00:00 PM Drug: Bumetanide Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Cefazolin Injection 1/8/2019 7:00:00 PM Drug: Cefazolin Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Ketamine Injection 1/8/2019 7:00:00 PM Drug: Ketamine Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Lorazepam Tablets 1/8/2019 7:00:00 PM Drug: Lorazepam Tablets, Revision Date: Wed, 09 Jan 2019 (Click for more...) Nystatin Oral Suspension 1/8/2019 7:00:00 PM Drug: Nystatin Oral Suspension, Revision Date: Wed, 09 Jan 2019 (Click for more...) Ondansetron Hydrochloride Injection 1/8/2019 7:00:00 PM Drug: Ondansetron Hydrochloride Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Orphenadrine Citrate Injection 1/8/2019 7:00:00 PM Drug: Orphenadrine Citrate Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Piperacillin and Tazobactam Injection 1/8/2019 7:00:00 PM Drug: Piperacillin and Tazobactam Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Promethazine Injection 1/8/2019 7:00:00 PM Drug: Promethazine Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Spironolactone Tablets 1/8/2019 7:00:00 PM Drug: Spironolactone Tablets, Revision Date: Wed, 09 Jan 2019 (Click for more...) Vancomycin Hydrochloride Injection 1/8/2019 7:00:00 PM Drug: Vancomycin Hydrochloride Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Belatacept Injection 1/8/2019 7:00:00 PM Drug: Belatacept Injection, Revision Date: Wed, 09 Jan 2019 (Click for more...) Brain-eating amoeba death highlights importance of safe neti pot use 1/8/2019 10:34:09 AM Brain-eating amoeba death highlights importance of safe neti pot use Tue, 01/08/2019 - 10:59 caldridgeyoung… Tue, 01/08/2019 - 10:34 It’s right out of a horror movie: a woman’s brain is devoured by amoeba over the course of a year, and by the time it’s discovered, it’s too late to save her. (Click for more...) Bisoprolol Fumarate Tablets 1/7/2019 7:00:00 PM Drug: Bisoprolol Fumarate Tablets, Revision Date: Tue, 08 Jan 2019 (Click for more...) Cefuroxime Sodium Injection 1/7/2019 7:00:00 PM Drug: Cefuroxime Sodium Injection, Revision Date: Tue, 08 Jan 2019 (Click for more...) Fentanyl Citrate Injection 1/7/2019 7:00:00 PM Drug: Fentanyl Citrate Injection, Revision Date: Tue, 08 Jan 2019 (Click for more...) Class-action suit against Merck puts common drugmaker defense to Supreme Court test 1/7/2019 4:15:54 PM Class-action suit against Merck puts common drugmaker defense to Supreme Court test Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 The case of Merck Sharp & Dohme Corp. v. Doris Albrecht will soon be considered by the U.S. Supreme Court. In the lawsuit, patients claimed that Merck failed to properly warn them about certain adverse effects, such as increased risk of fracturing their femurs, with the osteoporosis drug alendronate sodium (Fosamax). Patients asserted that Merck broke state "failure to warn" laws. For its part, Merck said that it attempted to warn patients by updating the drug label, but FDA prevented it. Merck said that it is not responsible for patients who suffered bone fractures because FDA blocked the proposed warnings from the label. "Regardless of the outcome of the case, this is going to be a very big deal, because [this defense is] a really important issue with respect to drug manufacturer liability," said Patti Zettler, an associate professor at the Georgia State University College of Law in Atlanta who used to work in FDA's office of chief counsel. The case will be watched closely by several industries because it addresses the issue of what happens when federal law and state law appear to be in conflict. (Click for more...) Mohawks sue opioid makers 1/7/2019 4:15:54 PM Mohawks sue opioid makers Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 The St. Regis Mohawk Tribe in New York state has filed a lawsuit in federal court against pharmaceutical manufacturers and distributors for the "devastating effects" that prescription opioids have had on the region. The lawsuit, filed in U.S. District Court for the Northern District of New York, accuses opioid manufacturers, marketers, and distributors of implementing a strategy to make doctors and patients believe that opioid analgesics were safe and non-addictive when taken for long-term pain. Tribal Chief Beverly Cook observes, "Children whose parents are addicted to opioids—including babies born with opioid dependencies as a result of their mothers' opioid use during pregnancy—often must be removed from their homes." The tribe estimates that the abuse of opioids is linked to 85%-90% of child-welfare cases annually for each of the last 5 years. "In response, the tribe has continually allocated resources to drug-abuse prevention and education, outpatient treatment programs through Health Services, inpatient treatment at the Partridge House, social services programming, public safety, and a Healing to Wellness Court, as well as participation in community coalitions aimed at reducing prescription drug abuse," says Tribal Chief Michael Conners. (Click for more...) Addressing a core gap in cancer care -- the NCI Moonshot program to help oncology patients stop smoking 1/7/2019 4:15:52 PM Addressing a core gap in cancer care -- the NCI Moonshot program to help oncology patients stop smoking Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Helping oncology patients kick a cigarette habit improves the odds of successful treatment and recovery, yet smoking-cessation continues to be a missing part of the care directive for many cancer patients. Research shows that fewer than 50% of providers consistently discuss medical cessation options with patients who smoke, about the same share who actually treat them or refer them for treatment. The low rate of intervention may be blamed on a variety of factors, from clinicians' prioritizing treatment of the cancer itself to their belief that smoking-cessation efforts will meet patient resistance and ultimately fail. To prevail in the face of these and other challenges, Robert T. Croyle and Glen D. Morgan of the National Cancer Institute (NCI) and Michael C. Fiore of the University of Wisconsin point to programs like NCI's Cancer Center Cessation Initiative (C3I). Part of the Cancer Moonshot, C31 stipulates that every cancer patient who smokes and seeks care at an NCI-designated facility should be identified, encouraged to quit, offered evidence-based cessation treatment, and monitored for the purpose of evaluating outcomes. Findings related to effective smoking-cessation interventions for oncology patients and best practices for implementing and delivering them will be synthesized and shared with clinical cancer facilities across the country. C3I promises to make smoking-cessation treatment an integral component of care for cancer patient who smokes, the authors conclude, and it could even eventually have a similar role for diabetics, people with COPD, and other patient populations. (Click for more...) FDA accuses Juul and Altria of backing off plan to stop youth vaping 1/7/2019 4:15:52 PM FDA accuses Juul and Altria of backing off plan to stop youth vaping Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 FDA Commissioner Scott Gottlieb is drafting letters to Juul and Altria that will criticize them for publicly pledging to remove nicotine flavor pods from store shelves, while secretly negotiating a financial partnership that seems to do the opposite. He plans to summon top executives of the companies to agency headquarters to explain how they will stick to their agreements given their new arrangement. Gottlieb has expressed concern over the commitments the companies made in the deal, under which Altria agreed to purchase a 35%—$13 billion—stake in Juul. Public health officials, as well as teachers and parents, fear that e-cigarettes have created a new generation of nicotine addicts. "Juul and Altria made very specific assertions in their letters and statements to FDA about the drivers of the youth epidemic," Gottlieb said in an interview. "Their recent actions and statements appear to be inconsistent with those commitments." The new deal commits the tobacco giant to dramatically expanding the reach of precisely those types of products, by giving Juul access to shelf space in 230,000 retail outlets where Marlboro cigarettes and other Altria tobacco products are sold. It is possible that FDA will pressure Altria to keep Juul flavor pods off its shelf space, but the tobacco company is not likely to consent. David Sutton, an Altria spokesman, said the company is merely a minority investor in Juul, and does not control its business. (Click for more...) Hy-Vee implements controlled substance prescription policy 1/7/2019 4:15:51 PM Hy-Vee implements controlled substance prescription policy Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Hy-Vee announced Friday that it has adopted a new controlled substance prescription policy, effective January 1, 2019. Under the policy, Hy-Vee pharmacies will no longer permit a subsequent fill of a Schedule II controlled substance or a refill of a Schedule III or Schedule IV controlled substance more than 72 hours early without clearance from the prescriber. "The opioid epidemic in the United States claims the lives of more than 100 people every day, and Hy-Vee is continually working to assist in the fight," said Kristin Williams, Hy-Vee senior vice president and chief health officer. "Implementing this 72-hour policy is one more step toward combatting the opioid epidemic in communities throughout the eight states we serve." In addition, Hy-Vee said its pharmacies will no longer accept GoodRx coupons for controlled substance prescriptions. The company already provides naloxone without a prescription in the eight states where it operates pharmacies. (Click for more...) Cerner and CoverMyMeds integrate prescription prices and a patient's ability to pay within EHR 1/7/2019 4:15:51 PM Cerner and CoverMyMeds integrate prescription prices and a patient's ability to pay within EHR Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Health care IT company Cerner and CoverMyMeds, which is part of McKesson Prescription Technology Solutions, are collaborating to enhance prescription price transparency by integrating prescription prices into the electronic health record (EHR) for providers and patients. The CoverMyMeds' RxBenefit Clarity solution is integrated into the Cerner ePrescribe workflow. The solution is expected to help inform providers as they make clinical decisions so a patient can afford the drug prescribed and avoid non-adherence. "As health care spending increases, the need for prescription price transparency is becoming as important as ever," said John Peterzalek, chief client officer of Cerner. "Access to valuable pricing information gives health care providers the opportunity to provide their patients with up-to-date information on the most appropriate and cost-effective medications before they reach the pharmacy." (Click for more...) Eli Lilly to buy Loxo Oncology for $8 billion in huge bet on cancer genetics 1/7/2019 4:15:49 PM Eli Lilly to buy Loxo Oncology for $8 billion in huge bet on cancer genetics Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Eli Lilly reported Monday that it will purchase the startup Loxo Oncology for $8 billion in cash to gain access to the company’s cancer medicines. Loxo’s first medicine, larotrectinib (Viktrakvi), was approved by FDA in November based on evidence that it can shrink tumors in 75% of patients whose cancer tests positive for a particular kind of genetic mutation. For 39% of those who respond, the tumor stays shrunk for a year or more. Loxo’s second drug, LOXO-292, targets patients with lung or thyroid cancer whose tumors test positive for another type of mutation, related to a gene called RET. In data presented last year at the annual meeting of the American Society of Clinical Oncology in Chicago, 77% of patients in a study of 37 patients with a particular type of RET mutation in either non-small-cell lung cancer, thyroid cancer, or pancreatic cancer saw their tumor shrink enough to have a response. (Click for more...) Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy 1/7/2019 4:15:47 PM Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 U.K. researchers examined the effect of weaning patients off of heart failure medication once their symptoms from dilated cardiomyopathy have resolved and cardiac function has been restored. They recruited 51 patients, randomizing 25 to phased treatment withdrawal and the rest to continued therapy. During the first 6 months of the pilot study, 11 patients (44%) assigned to the treatment termination group experienced a relapse of dilated cardiomyopathy vs. none of the patients in the continued therapy group. Similar results were observed during the next 6 months, when 25 of the 26 controls also attempted to discontinue medication. During that period, 9 of those participants relapsed. The results indicate that dilated cardiomyopathy is likely to return in the absence of continued treatment. Until solid predictors of relapse are identified, the investigators argue, the standard practice should be to administer treatment indefinitely. (Click for more...) When medicine makes patients sicker 1/7/2019 4:15:47 PM When medicine makes patients sicker Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 In the past 6 years, drugmakers have recalled about 8,000 medicines that have entered the U.S. drug supply, according to a Kaiser Health News (KHN) investigation. The flawed products contained everything from dangerous bacteria to tiny glass particles or the wrong amount of the drug's active ingredient. During the same time frame, 65 drug-making facilities recalled almost 300 products within 12 months of passing an FDA inspection, a KHN analysis of FDA recall notices and inspection records found. The agency is supposed to inspect all factories that make drugs for the U.S. market. But a KHN review of thousands of FDA documents revealed how problematic drugs can enter the market, as inspectors may miss serious risks, drug companies may fail to meet standards even after FDA has taken enforcement measures, and many pharmaceutical plants have not been inspected for years. FDA Commissioner Scott Gottlieb said the agency is "taking new steps" to identify problems before they occur and it is "not shy" to use its powers to mitigate risks. But the system can be manipulated and FDA's enforcement abilities are limited. (Click for more...) CDC: Pediatric influenza deaths now at 13, influenza widespread in 24 states 1/7/2019 4:15:45 PM CDC: Pediatric influenza deaths now at 13, influenza widespread in 24 states Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 CDC reported that influenza activity is widespread geographically in 24 states. In addition, New York City and 19 states are experiencing high influenza-like illness activity in terms of visits to outpatient providers for symptoms of influenza. For the week ending December 29, the proportion of outpatient visits for influenza-like illness in the United States rose 4.1%, above the national baseline of 2.2%. CDC noted that all 10 surveillance regions of the country reported influenza-like illness activity at or above their region-specific baseline level. According to CDC, the increase in the percentage of such patient visits may be "influenced in part by a reduction in routine health care visits during the winter holidays, as has occurred during previous seasons." Between October 1 and December 29, there were 1,562 laboratory-confirmed influenza-related hospitalizations. The highest rate of hospitalization was 14.5 hospitalizations per 100,000 population among children younger than age 5 years. CDC said that two additional influenza-related pediatric deaths had been reported, bringing the total number of pediatric deaths for this influenza season to 13. (Click for more...) Lupin Pharmaceuticals issues voluntary recall of ceftriaxone for injection 1/7/2019 4:15:45 PM Lupin Pharmaceuticals issues voluntary recall of ceftriaxone for injection Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Lupin Pharmaceuticals has launched a voluntary recall of several lots of ceftriaxone for injection due to visual gray particulate matter in reconstituted vials. The recall includes 5 lots of ceftriaxone for injection, USP, 250 mg; 10 lots of ceftriaxone for injection, USP, 500 mg; 24 lots of ceftriaxone for injection, USP, 1 g; and 3 lots of ceftriaxone for injection, USP, 2 g. Lupin has received no reports of adverse events related to the recalled lots thus far. However, the company notes that improper piercing and use of a needle greater than 21 gauge while reconstituting the vial can push rubber flecks into the solution. No gray flecks were seen before the reconstitution of the vials, and the issue was observed with standard visual inspection prior to patient administration. Ceftriaxone for injection, USP, is packaged in a glass vial, in pack of 10, with 10 vials in a carton, with NDC 68180-611-10, 68180-622-10, 68180-633-10, 68180-644-10 and as single pack containing one glass vial in a carton with NDC 68180-611-01, 68180-622-01, 68180-633-01. (Click for more...) How insurers kept extra cash from Medicare 1/7/2019 4:15:43 PM How insurers kept extra cash from Medicare Sun, 01/06/2019 - 19:00 cbaker_admin Mon, 01/07/2019 - 16:15 Most health insurers' forecasts for providing prescription-drug benefits to more than 40 million people on Medicare have, thanks to Medicare's payment rules, resulted in more revenue for the firms. A Wall Street Journal investigation found that as a consequence, the insurers kept $9.1 billion more in taxpayer funds than they would have had their estimates been accurate from 2006 to 2015. Medicare Part D was designed to help hold down drug costs by having insurers manage the coverage efficiently. Instead, Part D spending has accelerated faster than all other components of Medicare in recent years, rising 49% from $62.9 billion in 2010 to $93.8 billion in 2017. Medicare experts say the program’s design is contributing to that increase. Private insurers submit "bids" estimating how much it will cost them to provide the benefit. Then Medicare uses the estimates to make monthly payments to the plans. If the insurer overestimated its costs, it pockets a chunk of the extra money it received from Medicare—sometimes all of it. In 2015, insurers overestimated costs by about $2.2 billion, and kept about $1.06 billion of it after paying back $1.1 billion to the government. The companies say the pattern of overestimates identified is the result of unpredictable drug pricing by pharmaceutical manufacturers. Insurers say they strive to make accurate bids, which are certified by professional actuaries. (Click for more...) AMA calls on states to remove prior authorization for opioid treatment 1/7/2019 3:07:42 PM AMA calls on states to remove prior authorization for opioid treatment Mon, 01/07/2019 - 15:17 caldridgeyoung… Mon, 01/07/2019 - 15:07 Following the news that Pennsylvania will remove prior authorization requirements for medication-assisted treatment (MAT) for opioid-use disorder, the president of the American Medical Association (AMA) called on payers in every state to do the same. (Click for more...) Lori Hazlehurst Named As WVU Cancer Institute Associate Director 1/7/2019 12:00:00 AM Lori Hazlehurst, PhD, Professor (WVU School of Pharmacy - Pharmaceutical Sciences and Co-Leader of the WVU Cancer Institute Research Program the Alexander B. Osborn Hematopoietic Malignancy and Transplantation Program) has been named as the Associate Director for Basic Research at the WVU Cancer Institute. In this role, Hazlehurst will work closely with Dr. Richard Goldberg, institute director, and the leadership team of the WVU Cancer Institute to implement strategic goals to increase the impact of basic and translational cancer research at WVU. The primary strategy is to increase the number of NIH funded investigators focused on cancer research at WVU. (Click for more...) Ketorolac Injection 1/6/2019 7:00:00 PM Drug: Ketorolac Injection, Revision Date: Mon, 07 Jan 2019 (Click for more...) Latanoprost Ophthalmic Solution 1/6/2019 7:00:00 PM Drug: Latanoprost Ophthalmic Solution, Revision Date: Mon, 07 Jan 2019 (Click for more...) Lidocaine with Epinephrine Injection 1/6/2019 7:00:00 PM Drug: Lidocaine with Epinephrine Injection, Revision Date: Mon, 07 Jan 2019 (Click for more...) Magnesium Sulfate Injection 1/6/2019 7:00:00 PM Drug: Magnesium Sulfate Injection, Revision Date: Mon, 07 Jan 2019 (Click for more...) Mannitol Injection 1/6/2019 7:00:00 PM Drug: Mannitol Injection, Revision Date: Mon, 07 Jan 2019 (Click for more...) Mycophenolate Mofetil Capsules and Tablets 1/6/2019 7:00:00 PM Drug: Mycophenolate Mofetil Capsules and Tablets, Revision Date: Mon, 07 Jan 2019 (Click for more...) Rosuvastatin Calcium Tablets 1/6/2019 7:00:00 PM Drug: Rosuvastatin Calcium Tablets, Revision Date: Mon, 07 Jan 2019 (Click for more...) Sodium Acetate Injection 1/6/2019 7:00:00 PM Drug: Sodium Acetate Injection, Revision Date: Mon, 07 Jan 2019 (Click for more...) Sterile Water for Injection - Small Volume Vials 1/6/2019 7:00:00 PM Drug: Sterile Water for Injection - Small Volume Vials, Revision Date: Mon, 07 Jan 2019 (Click for more...) Rite Aid agrees to pay $300,000 for over-dispensing drugs in Rhode Island 1/4/2019 2:29:40 PM Rite Aid agrees to pay $300,000 for over-dispensing drugs in Rhode Island Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Rite Aid has reached a settlement with Rhode Island Attorney General Peter Kilmartin's office for violating the Rhode Island Controlled Substance Act between September 2014 and February 2017. According to the settlement, Rite Aid stores in Rhode Island dispensed Schedule III controlled substances in excess of 100-dosage units, the maximum allowed to be dispensed at one time. DEA's Providence office began its investigation after being notified about someone passing fraudulent prescriptions for Schedule III controlled substances. Rite Aid will pay a $300,000 penalty, which will go towards implementing programs and services for the prevention, treatment, and recovery relating to substance use disorders. Rite Aid has also agreed to implement electronic systems to prevent over dispensing and instruct its pharmacists in Rhode Island stores on the dispensing limitations imposed by the Controlled Substances Act. (Click for more...) Tennessee pharmacists struggle to adjust to new opioid laws 1/4/2019 2:29:38 PM Tennessee pharmacists struggle to adjust to new opioid laws Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 As of January, pharmacies in Tennessee are required to record prescriptions with a medical code to its system. The data will then be sent to the Controlled Substance Monitoring Database (CSMD), where state officials can keep track of what type of opioids and to whom are being prescribed. Micah Cost of the Tennessee Pharmacists Association says it has already been a struggle since pharmacists have been adjusting to previous prescription laws set in July. "We're still struggling with the implementation of it especially the partial-fill provisions," Cost says. Different software systems pharmacists use are not able to handle the changes, according to Cost. "It's really an innovative concept and pharmacy software systems have the capability to do but not in the capacity the state is requiring right now," Cost says. "Some systems are not handling it, and some software systems say we're not going to comply and go with the lowest possible quantity and you'll have to go back to your doctor again." (Click for more...) Arkansas Pharmacist Association: Keeping your New Year's resolution 1/4/2019 2:29:38 PM Arkansas Pharmacist Association: Keeping your New Year's resolution Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 The Arkansas Pharmacist Association offers advice for keeping the most important New Year's resolution: taking care of your overall health. One key part of that is medication adherence. Two options can help people struggling to stay adherent to their medication. First, special packaging allows a pharmacist to group a person's medications by time of day that they are taken; and second, medication synchronization allows you to sync all of your prescriptions to be picked up on the same day. Another priority is making sure you are up to date on your immunizations. Many pharmacists can provide a variety of immunizations in a matter of minutes without the need for scheduling an appointment ahead of time. Other issues the pharmacist association discusses are healthy sleep habits and smoking cessation. (Click for more...) Medicaid patients in Puerto Rico don't get coverage for drugs to cure hepatitis C 1/4/2019 2:29:38 PM Medicaid patients in Puerto Rico don't get coverage for drugs to cure hepatitis C Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Medicaid patients in Puerto Rico receive no Medicaid coverage for hepatitis C drugs. The joint federal-territory health care program for the poor—which covers about one-half the island’s population—does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail. The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV but expanded the program later to those with only hepatitis C. However, the program ran out of funding and is no longer accepting patients only with hepatitis C. The Puerto Rico Health Insurance Administration, which oversees Medicaid, said it is working with a pharmaceutical company to create a cost-effective system to provide these medications. (Click for more...) FDA approves Teva's digital inhaler for asthma and COPD patients 1/4/2019 2:29:37 PM FDA approves Teva's digital inhaler for asthma and COPD patients Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Teva Pharmaceutical Industries' ProAir inhaler has been approved by FDA for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm in patients aged 4 years and older. The company describes the device as "the first and only digital inhaler with built-in sensors that detect when the inhaler is used and measure inhalation flow." The inhaler is linked to a companion mobile application that provides inhaler-use data to people with asthma and COPD via Bluetooth technology so patients can review their data over time and share it with health care professionals. Tonya Winders, president and CEO of the Allergy & Asthma Network, observes: "[The FDA approval of Teva's device] may help patients track their inhaler usage and provide data that can be used to work more closely with their health care providers on their asthma management." Teva says its ProAir Digihaler will be available in 2019 through a small number of "early experience" programs, which will be launched in conjunction with health care systems and in limited areas "in order to gather real-world experience." Nationwide distribution of the device is planned for 2020. (Click for more...) New HRSA program will help clinicians and patients in the fight against opioid addiction 1/4/2019 2:29:37 PM New HRSA program will help clinicians and patients in the fight against opioid addiction Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 A new Health Resources and Services administration (HRSA) loan repayment program will provide substance use disorder treatment in underserved parts of the United States. Under the National Health Service Corps Substance Use Disorder Workforce Loan Repayment Program, eligible health care clinicians will receive student loan repayment assistance in return for their service on the front lines of the opioid epidemic in underserved areas. More people who need help with substance use treatment will then have access to highly qualified clinicians. HRSA Administrator George Sigounas notes, "By strengthening the health workforce, HRSA is working to ensure that there are enough qualified health care clinicians to treat patients living with substance use disorder." He adds, "The current opioid crisis is daunting, but the new NHSC loan repayment program will help us make strides in this public health challenge. I am grateful to the clinicians who will apply and are looking to make a positive impact on patients, caregivers, and hard-hit communities throughout the country." (Click for more...) Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma 1/4/2019 2:29:35 PM Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Encouraged by promising results from a single-site Phase IIa study, researchers undertook an international Phase II investigation of tisagenlecleucel in the setting of large B-cell lymphoma. The JULIET trial included 93 adults who failed to respond to first- and second-line treatments or who suffered disease progression after autologous hematopoietic stem-cell transplantation. Participants received an infusion of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that has been shown to eliminate CD19-expressing B cells. A total of 40% of the patients had complete responses to the intervention, with 12 exhibiting partial responses. The best overall response rate—the primary outcome—was 52%. High rates of durable response were affirmed 1 year after the initial response, when relapse-free survival was about 65% overall and about 79% among patients with a complete response. Although three participants died from disease progression within 30 days of infusion, their deaths were not attributed to tisagenlecleucel or associated adverse effects. (Click for more...) Marine n-3 fatty acids and prevention of cardiovascular disease and cancer 1/4/2019 2:29:35 PM Marine n-3 fatty acids and prevention of cardiovascular disease and cancer Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Organically high consumption of marine n-3 fatty acids has been linked to lower risk of cardiovascular (CV) disease and cancer, raising the question of the preventive potential of supplements. A Harvard study explored this possibility in a large population of U.S. adults aged 50 years and older. More than 25,800 participants were randomized to 1 gram per day of marine n-3 fatty acids, better known as omega-3 acids, or to placebo. One primary endpoint was CV events, which occurred in 386 people in the intervention group and 419 controls after about 5 years. The other main co-outcome was incidence of any kind of invasive cancer, which affected 820 omega-3 recipients and 797 controls. The data do not support dietary supplementation with n-3 fatty acids, which appear to have no measurable prophylactic benefit over placebo with respect to major CV events or cancer. (Click for more...) Nebraska, Texas hold top spots on Walgreens' influenza Index 1/4/2019 2:29:35 PM Nebraska, Texas hold top spots on Walgreens' influenza Index Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 A weekly influenza index released by Walgreens ranks the states and markets experiencing the highest influenza incidences nationwide. For the week ending on December 22, the top 10 designated market areas (DMAs) with influenza activity were Lincoln & Hastings-Kearney, NE; El Paso, TX/Las Cruces, NM; Harlingen-Weslaco-Brownsville-McAllen, TX; Montgomery-Selma, AL; Chattanooga, TN; Dallas-Ft. Worth, TX; Omaha, NE; Columbus, GA/Opelika, AL; Atlanta; and Memphis. The top 10 states with influenza activity for the week ending December 22 were Nebraska, Tennessee, Texas, Georgia, Alabama, New Mexico, Kentucky, Colorado, Puerto Rico, and New Jersey. The top 10 DMAs with influenza activity gains for that week were Lincoln & Hastings-Kearney, NE; El Paso, TX/Las Cruces, NM; and Chattanooga, TN; Omaha, NE; Columbus, GA/Opelika, AL; Montgomery-Selma, AL; Dallas-Ft. Worth, TX; Memphis; Louisville; and Atlanta. Finally, the top 10 states with influenza activity gains for the week ending December 22 were Nebraska, Tennessee, Kentucky, New Mexico, Georgia, Texas, Alabama, Colorado, Wyoming, and Mississippi. (Click for more...) Torrent expands recall of losartan potassium tablets 1/4/2019 2:29:33 PM Torrent expands recall of losartan potassium tablets Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Torrent Pharmaceuticals is expanding its voluntary recall to include eight additional lots of losartan potassium tablets, for a total of 10 lots. The recall is being undertaken due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) in an active pharmaceutical ingredient made by Hetero Labs Ltd. Torrent is only recalling lots of losartan-containing products that contain NDEA above the acceptable daily intake levels. The company has received no reports of adverse events related to the recall thus far. (Click for more...) 102 cases of measles confirmed in Rockland 1/4/2019 2:29:33 PM 102 cases of measles confirmed in Rockland Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 An outbreak of measles in Rockland County, NY, has affected more than 100 people, health officials reported Thursday. The county had recorded 96 confirmed cases as of December 31, but the confirmation of 6 more cases pushed the total to 102 on January 3. Another 5 cases are being investigated. The new cases require the county to restart its 21-day countdown for ending restrictions on schools where less than 80% of the student body is vaccinated. As a result, the restrictions remain on schools in the center of the outbreak: Monsey, Spring Valley, and New Square. Students who are unvaccinated or under-vaccinated may not attend schools where the vaccination rate is lower than 80% until 21 days after the last confirmed case in the county. (Click for more...) Advances in cancer drugs fuel blockbuster deal 1/4/2019 2:29:32 PM Advances in cancer drugs fuel blockbuster deal Thu, 01/03/2019 - 19:00 cbaker_admin Fri, 01/04/2019 - 14:29 Bristol-Myers Squibb's $74 billion deal to acquire rival Celgene creates a cancer drug powerhouse amid industrywide optimism about the rapidly evolving science and explosive growth of the sector, where major scientific advances have led to groundbreaking new medicines. The agreement could signal a return of deal-making to the pharmaceutical industry as a whole, particularly in the $123 billion market for cancer drugs, now one of the biggest pharmaceutical sectors. In December, GlaxoSmithKline returned to the cancer-drugs market by agreeing to buy Tesaro and its ovarian cancer drug for $4.16 billion. Being bigger helps pharmaceutical companies in the negotiations with insurance companies and PBMs that determine reimbursement and coverage. As valuations of biotech companies have declined, they are becoming more attractive targets to major firms with continued access to cash. During the past decade or so, millions of cancer patients have benefited from new treatments. At the same time, the medicines have been profitable for drug manufacturers, with operating margins that can run has high as 60%–70%, according to analysts. The combined company created by the Bristol-Myers acquisition of Celgene will provide nine treatments with more than $1 billion in sales. (Click for more...) 23andMe releases pharmacogenomics test that doesn’t require prescription 1/4/2019 10:19:19 AM 23andMe releases pharmacogenomics test that doesn’t require prescription Fri, 01/04/2019 - 10:26 ehaberkorn@aph… Fri, 01/04/2019 - 10:19 Upwards of 20 companies and more than 70 labs offer pharmacogenomics testing through a health care practitioner, giving patients and providers insight into how patients might respond to certain medications. As pharmacists and other practitioners are trying to get up to speed with this new science, the consumer genetics testing company 23andMe announced in late 2018 that it gained FDA approval for a first-of-its-kind pharmacogenomics test that can bypass a practitioner completely. (Click for more...) Export Control Fast Facts: What you need to know 1/4/2019 12:00:00 AM The training will highlight the importance of compliance with U.S. export laws and regulations, HSC faculty and staff's personal responsibilities, and the processes designed to assist them. In particular, the information will look at how export regulations intersect with research, travel abroad, and the ways the Export Control office works with the Office of Global Affairs in the visa process for J-1 scholars and H-1B employees working in each school at HSC. (Click for more...) Argatroban Injection 1/3/2019 7:00:00 PM Drug: Argatroban Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) Dexamethasone Sodium Phosphate Injection 1/3/2019 7:00:00 PM Drug: Dexamethasone Sodium Phosphate Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection 1/3/2019 7:00:00 PM Drug: Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) Fluconazole Injection 1/3/2019 7:00:00 PM Drug: Fluconazole Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) Fluorouracil Injection 1/3/2019 7:00:00 PM Drug: Fluorouracil Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) Guanfacine Hydrochloride Tablets 1/3/2019 7:00:00 PM Drug: Guanfacine Hydrochloride Tablets, Revision Date: Fri, 04 Jan 2019 (Click for more...) Heparin Injection 1/3/2019 7:00:00 PM Drug: Heparin Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) C1-Esterase Inhibitor (Human) Injection 1/3/2019 7:00:00 PM Drug: C1-Esterase Inhibitor (Human) Injection, Revision Date: Fri, 04 Jan 2019 (Click for more...) 50% Dextrose Injection 1/2/2019 7:00:00 PM Drug: 50% Dextrose Injection, Revision Date: Thu, 03 Jan 2019 (Click for more...) Abciximab Injection 1/2/2019 7:00:00 PM Drug: Abciximab Injection, Revision Date: Thu, 03 Jan 2019 (Click for more...) Atropine Sulfate Injection 1/2/2019 7:00:00 PM Drug: Atropine Sulfate Injection, Revision Date: Thu, 03 Jan 2019 (Click for more...) Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection 1/2/2019 7:00:00 PM Drug: Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection, Revision Date: Thu, 03 Jan 2019 (Click for more...) Trifluoperazine Tablets 1/2/2019 7:00:00 PM Drug: Trifluoperazine Tablets, Revision Date: Thu, 03 Jan 2019 (Click for more...) Bacteriostatic 0.9% Sodium Chloride Vials 12/26/2018 7:00:00 PM Drug: Bacteriostatic 0.9% Sodium Chloride Vials, Revision Date: Thu, 27 Dec 2018 (Click for more...) Bupivacaine with Epinephrine Injection 12/26/2018 7:00:00 PM Drug: Bupivacaine with Epinephrine Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Carbidopa and Levodopa Extended-Release Tablets 12/26/2018 7:00:00 PM Drug: Carbidopa and Levodopa Extended-Release Tablets, Revision Date: Thu, 27 Dec 2018 (Click for more...) Diphenhydramine Injection 12/26/2018 7:00:00 PM Drug: Diphenhydramine Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Melphalan Tablets 12/26/2018 7:00:00 PM Drug: Melphalan Tablets, Revision Date: Thu, 27 Dec 2018 (Click for more...) Mepivacaine Injection 12/26/2018 7:00:00 PM Drug: Mepivacaine Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Morphine Injection 12/26/2018 7:00:00 PM Drug: Morphine Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Ropivacaine Injection 12/26/2018 7:00:00 PM Drug: Ropivacaine Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Tobramycin Sulfate Injection 12/26/2018 7:00:00 PM Drug: Tobramycin Sulfate Injection, Revision Date: Thu, 27 Dec 2018 (Click for more...) Albuterol Inhalation Solution 12/25/2018 7:00:00 PM Drug: Albuterol Inhalation Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Alcohol Dehydrated Injection (Ethanol) 12/25/2018 7:00:00 PM Drug: Alcohol Dehydrated Injection (Ethanol), Revision Date: Wed, 26 Dec 2018 (Click for more...) Amyl Nitrite Inhalation 12/25/2018 7:00:00 PM Drug: Amyl Nitrite Inhalation, Revision Date: Wed, 26 Dec 2018 (Click for more...) Buspirone Tablets 12/25/2018 7:00:00 PM Drug: Buspirone Tablets, Revision Date: Wed, 26 Dec 2018 (Click for more...) Calcitriol Injection 12/25/2018 7:00:00 PM Drug: Calcitriol Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Cidofovir Injection 12/25/2018 7:00:00 PM Drug: Cidofovir Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Ciprofloxacin Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Ciprofloxacin Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Diclofenac 0.1% Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Diclofenac 0.1% Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Diltiazem Extended-Release Capsules (Twice-Daily Dosing) 12/25/2018 7:00:00 PM Drug: Diltiazem Extended-Release Capsules (Twice-Daily Dosing), Revision Date: Wed, 26 Dec 2018 (Click for more...) Diltiazem Hydrochloride Injection 12/25/2018 7:00:00 PM Drug: Diltiazem Hydrochloride Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Dorzolamide Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Dorzolamide Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Fluorescein Sodium Ophthalmic Strips 12/25/2018 7:00:00 PM Drug: Fluorescein Sodium Ophthalmic Strips, Revision Date: Wed, 26 Dec 2018 (Click for more...) Gentamicin Sulfate Ophthalmic Ointment 12/25/2018 7:00:00 PM Drug: Gentamicin Sulfate Ophthalmic Ointment, Revision Date: Wed, 26 Dec 2018 (Click for more...) Hydralazine injection 12/25/2018 7:00:00 PM Drug: Hydralazine injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Hypromellose Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Hypromellose Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Indocyanine Green 12/25/2018 7:00:00 PM Drug: Indocyanine Green, Revision Date: Wed, 26 Dec 2018 (Click for more...) Methocarbamol Tablets 12/25/2018 7:00:00 PM Drug: Methocarbamol Tablets, Revision Date: Wed, 26 Dec 2018 (Click for more...) Methylene Blue 12/25/2018 7:00:00 PM Drug: Methylene Blue, Revision Date: Wed, 26 Dec 2018 (Click for more...) Multiple Vitamins for Infusion 12/25/2018 7:00:00 PM Drug: Multiple Vitamins for Infusion, Revision Date: Wed, 26 Dec 2018 (Click for more...) Octreotide Injection 12/25/2018 7:00:00 PM Drug: Octreotide Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Olanzapine Intramuscular Injection 12/25/2018 7:00:00 PM Drug: Olanzapine Intramuscular Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Penicillin G Procaine Injection 12/25/2018 7:00:00 PM Drug: Penicillin G Procaine Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Proparacaine Hydrochloride Ophthalmic Solution 12/25/2018 7:00:00 PM Drug: Proparacaine Hydrochloride Ophthalmic Solution, Revision Date: Wed, 26 Dec 2018 (Click for more...) Sufentanil Injection 12/25/2018 7:00:00 PM Drug: Sufentanil Injection, Revision Date: Wed, 26 Dec 2018 (Click for more...) Temazepam Capsules 12/25/2018 7:00:00 PM Drug: Temazepam Capsules, Revision Date: Wed, 26 Dec 2018 (Click for more...) Etomidate Injection 12/23/2018 7:00:00 PM Drug: Etomidate Injection, Revision Date: Mon, 24 Dec 2018 (Click for more...) Metoclopramide Injection 12/23/2018 7:00:00 PM Drug: Metoclopramide Injection, Revision Date: Mon, 24 Dec 2018 (Click for more...) Aminophylline Injection 12/21/2018 7:00:00 PM Drug: Aminophylline Injection, Revision Date: Sat, 22 Dec 2018 (Click for more...) Butorphanol Tartrate Injection 12/21/2018 7:00:00 PM Drug: Butorphanol Tartrate Injection, Revision Date: Sat, 22 Dec 2018 (Click for more...) Dopamine Hydrochloride Injection 12/21/2018 7:00:00 PM Drug: Dopamine Hydrochloride Injection, Revision Date: Sat, 22 Dec 2018 (Click for more...) Famotidine Injection 12/21/2018 7:00:00 PM Drug: Famotidine Injection, Revision Date: Sat, 22 Dec 2018 (Click for more...) Lorazepam Injection 12/21/2018 7:00:00 PM Drug: Lorazepam Injection, Revision Date: Sat, 22 Dec 2018 (Click for more...) Calcium Gluconate Injection 12/20/2018 7:00:00 PM Drug: Calcium Gluconate Injection, Revision Date: Fri, 21 Dec 2018 (Click for more...) Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution 12/20/2018 7:00:00 PM Drug: Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution, Revision Date: Fri, 21 Dec 2018 (Click for more...) Flumazenil Injection 12/20/2018 7:00:00 PM Drug: Flumazenil Injection, Revision Date: Fri, 21 Dec 2018 (Click for more...) Methadone Injection 12/20/2018 7:00:00 PM Drug: Methadone Injection, Revision Date: Fri, 21 Dec 2018 (Click for more...) Metoprolol Injection 12/20/2018 7:00:00 PM Drug: Metoprolol Injection, Revision Date: Fri, 21 Dec 2018 (Click for more...) Pyridoxine Hydrochloride Injection 12/20/2018 7:00:00 PM Drug: Pyridoxine Hydrochloride Injection, Revision Date: Fri, 21 Dec 2018 (Click for more...) Recombinant Zoster Vaccine (Shingrix) 12/20/2018 7:00:00 PM Drug: Recombinant Zoster Vaccine (Shingrix), Revision Date: Fri, 21 Dec 2018 (Click for more...) Thiothixene Capsules 12/20/2018 7:00:00 PM Drug: Thiothixene Capsules, Revision Date: Fri, 21 Dec 2018 (Click for more...) Amiodarone Injection 12/19/2018 7:00:00 PM Drug: Amiodarone Injection, Revision Date: Thu, 20 Dec 2018 (Click for more...) Meropenem Injection 12/19/2018 7:00:00 PM Drug: Meropenem Injection, Revision Date: Thu, 20 Dec 2018 (Click for more...) Morphine Sulfate Immediate-Release Tablets 12/19/2018 7:00:00 PM Drug: Morphine Sulfate Immediate-Release Tablets, Revision Date: Thu, 20 Dec 2018 (Click for more...) Phenytoin Sodium Injection 12/19/2018 7:00:00 PM Drug: Phenytoin Sodium Injection, Revision Date: Thu, 20 Dec 2018 (Click for more...) Ceftriaxone Sodium Injection 12/18/2018 7:00:00 PM Drug: Ceftriaxone Sodium Injection, Revision Date: Wed, 19 Dec 2018 (Click for more...) Doxorubicin Injection 12/18/2018 7:00:00 PM Drug: Doxorubicin Injection, Revision Date: Wed, 19 Dec 2018 (Click for more...) Furosemide Tablets 12/18/2018 7:00:00 PM Drug: Furosemide Tablets, Revision Date: Wed, 19 Dec 2018 (Click for more...) Hepatitis B Vaccine (Recombinant) 12/18/2018 7:00:00 PM Drug: Hepatitis B Vaccine (Recombinant), Revision Date: Wed, 19 Dec 2018 (Click for more...) Methylphenidate Extended-Release Oral Suspension and Chewable Tablets 12/18/2018 7:00:00 PM Drug: Methylphenidate Extended-Release Oral Suspension and Chewable Tablets, Revision Date: Wed, 19 Dec 2018 (Click for more...) Sincalide Injection 12/18/2018 7:00:00 PM Drug: Sincalide Injection, Revision Date: Wed, 19 Dec 2018 (Click for more...) Ceftazidime Injection 12/17/2018 7:00:00 PM Drug: Ceftazidime Injection, Revision Date: Tue, 18 Dec 2018 (Click for more...) Nelarabine Injection 12/17/2018 7:00:00 PM Drug: Nelarabine Injection, Revision Date: Tue, 18 Dec 2018 (Click for more...) Cisplatin Injection 12/17/2018 7:00:00 PM Drug: Cisplatin Injection, Revision Date: Tue, 18 Dec 2018 (Click for more...) 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes 12/16/2018 7:00:00 PM Drug: 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes, Revision Date: Mon, 17 Dec 2018 (Click for more...) 23.4% Sodium Chloride Injection 12/16/2018 7:00:00 PM Drug: 23.4% Sodium Chloride Injection, Revision Date: Mon, 17 Dec 2018 (Click for more...) Iron Dextran Injection 12/16/2018 7:00:00 PM Drug: Iron Dextran Injection, Revision Date: Mon, 17 Dec 2018 (Click for more...) Mitoxantrone Hydrochloride Injection 12/16/2018 7:00:00 PM Drug: Mitoxantrone Hydrochloride Injection, Revision Date: Mon, 17 Dec 2018 (Click for more...) Dalbavancin Injection 12/16/2018 7:00:00 PM Drug: Dalbavancin Injection, Revision Date: Mon, 17 Dec 2018 (Click for more...) 25% Dextrose Injection 12/14/2018 7:00:00 PM Drug: 25% Dextrose Injection, Revision Date: Sat, 15 Dec 2018 (Click for more...) Acetylcysteine Oral and Inhalation Solution 12/14/2018 7:00:00 PM Drug: Acetylcysteine Oral and Inhalation Solution, Revision Date: Sat, 15 Dec 2018 (Click for more...) Diazepam Injection 12/14/2018 7:00:00 PM Drug: Diazepam Injection, Revision Date: Sat, 15 Dec 2018 (Click for more...) Meperidine Hydrochloride Injection 12/14/2018 7:00:00 PM Drug: Meperidine Hydrochloride Injection, Revision Date: Sat, 15 Dec 2018 (Click for more...) Pentostatin Injection 12/14/2018 7:00:00 PM Drug: Pentostatin Injection, Revision Date: Sat, 15 Dec 2018 (Click for more...) Clindamycin Phosphate Injection 12/13/2018 7:00:00 PM Drug: Clindamycin Phosphate Injection, Revision Date: Fri, 14 Dec 2018 (Click for more...) Deferoxamine Injection 12/13/2018 7:00:00 PM Drug: Deferoxamine Injection, Revision Date: Fri, 14 Dec 2018 (Click for more...) Fludrocortisone Acetate Tablets 12/13/2018 7:00:00 PM Drug: Fludrocortisone Acetate Tablets, Revision Date: Fri, 14 Dec 2018 (Click for more...) Valsartan and Hydrochlorothiazide Tablets 12/13/2018 7:00:00 PM Drug: Valsartan and Hydrochlorothiazide Tablets, Revision Date: Fri, 14 Dec 2018 (Click for more...) Valsartan Tablets 12/13/2018 7:00:00 PM Drug: Valsartan Tablets, Revision Date: Fri, 14 Dec 2018 (Click for more...) Daptomycin Injection 12/12/2018 7:00:00 PM Drug: Daptomycin Injection, Revision Date: Thu, 13 Dec 2018 (Click for more...) Remifentanil Injection 12/12/2018 7:00:00 PM Drug: Remifentanil Injection, Revision Date: Thu, 13 Dec 2018 (Click for more...) Vecuronium Bromide Injection 12/12/2018 7:00:00 PM Drug: Vecuronium Bromide Injection, Revision Date: Thu, 13 Dec 2018 (Click for more...) Atenolol and Chlorthalidone Tablets 12/12/2018 7:00:00 PM Drug: Atenolol and Chlorthalidone Tablets, Revision Date: Thu, 13 Dec 2018 (Click for more...) Emulating start-up success with purpose-built data tools 12/12/2018 4:12:17 PM Innovation used to be almost solely accredited to Big Pharma, but many of the more established businesses in the industry are finding that their rate of discovery is slowing as they try to find answers to some the industry’s biggest problems, such as antibiotic resistance. Meanwhile, over the last five years, pharmaceutical start-ups have enjoyed […] (Click for more...) Hydroxyethyl Starch in Sodium Chloride Injection 12/10/2018 7:00:00 PM Drug: Hydroxyethyl Starch in Sodium Chloride Injection, Revision Date: Tue, 11 Dec 2018 (Click for more...) Methotrexate Injection 12/10/2018 7:00:00 PM Drug: Methotrexate Injection, Revision Date: Tue, 11 Dec 2018 (Click for more...) Metronidazole Hydrochloride Injection 12/10/2018 7:00:00 PM Drug: Metronidazole Hydrochloride Injection, Revision Date: Tue, 11 Dec 2018 (Click for more...) Dobutamine Injection 12/9/2018 7:00:00 PM Drug: Dobutamine Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Haloperidol Tablets 12/9/2018 7:00:00 PM Drug: Haloperidol Tablets, Revision Date: Mon, 10 Dec 2018 (Click for more...) Hydroxocobalamin Injection 12/9/2018 7:00:00 PM Drug: Hydroxocobalamin Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Hydroxyprogesterone Caproate Injection 12/9/2018 7:00:00 PM Drug: Hydroxyprogesterone Caproate Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Levetiracetam Injection 12/9/2018 7:00:00 PM Drug: Levetiracetam Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Oxacillin Sodium Injection 12/9/2018 7:00:00 PM Drug: Oxacillin Sodium Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Scopolamine Transdermal System 12/9/2018 7:00:00 PM Drug: Scopolamine Transdermal System, Revision Date: Mon, 10 Dec 2018 (Click for more...) Chloroprocaine Hydrochloride Injection 12/9/2018 7:00:00 PM Drug: Chloroprocaine Hydrochloride Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Etoposide Solution for Injection 12/9/2018 7:00:00 PM Drug: Etoposide Solution for Injection, Revision Date: Mon, 10 Dec 2018 (Click for more...) Games and Events: A New Era of Coopetition in Pharma R&D 12/8/2018 1:11:27 PM Although R&D competition remains as fierce as ever, many pharmaceutical companies engage in various types of cooperation and partnership ventures to help drive innovation. The goal of coopetition — when companies cooperate on certain projects while maintaining a competitive stance — is to make drug development more efficient and effective. Events that foster the competitive […] (Click for more...) Enalaprilat Injection 12/7/2018 7:00:00 PM Drug: Enalaprilat Injection, Revision Date: Sat, 08 Dec 2018 (Click for more...) Epinephrine Injection 12/7/2018 7:00:00 PM Drug: Epinephrine Injection, Revision Date: Sat, 08 Dec 2018 (Click for more...) 14.6% Sodium Chloride Concentrated Solution for Injection 12/6/2018 7:00:00 PM Drug: 14.6% Sodium Chloride Concentrated Solution for Injection, Revision Date: Fri, 07 Dec 2018 (Click for more...) Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection 12/6/2018 7:00:00 PM Drug: Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection, Revision Date: Fri, 07 Dec 2018 (Click for more...) Testosterone Enanthate Intramuscular Injection 12/6/2018 7:00:00 PM Drug: Testosterone Enanthate Intramuscular Injection, Revision Date: Fri, 07 Dec 2018 (Click for more...) Thrombin Topical Powder (Recombinant) 12/6/2018 7:00:00 PM Drug: Thrombin Topical Powder (Recombinant), Revision Date: Fri, 07 Dec 2018 (Click for more...) Azithromycin Injection 12/5/2018 7:00:00 PM Drug: Azithromycin Injection, Revision Date: Thu, 06 Dec 2018 (Click for more...) Midodrine Tablets 12/5/2018 7:00:00 PM Drug: Midodrine Tablets, Revision Date: Thu, 06 Dec 2018 (Click for more...) Mupirocin Calcium 2% Cream 12/5/2018 7:00:00 PM Drug: Mupirocin Calcium 2% Cream, Revision Date: Thu, 06 Dec 2018 (Click for more...) Mupirocin Calcium 2% Nasal Ointment 12/5/2018 7:00:00 PM Drug: Mupirocin Calcium 2% Nasal Ointment, Revision Date: Thu, 06 Dec 2018 (Click for more...) Researchers at LegoChem Biosciences Share How Information Solutions Power Their Innovative Work 12/4/2018 5:07:53 AM With its groundbreaking work in developing antibody-drug conjugates, antibiotics, anti-coagulants and anti-cancer therapies, LegoChem Biosciences was already doing important research before joining The Hive. But the advantage of being a part of the Hive program – which gives specially-selected participants access to Elsevier’s R&D solutions – has been to help this innovative company accelerate and […] (Click for more...) Buprenorphine Hydrochloride Injection 12/3/2018 7:00:00 PM Drug: Buprenorphine Hydrochloride Injection, Revision Date: Tue, 04 Dec 2018 (Click for more...) Morphine PCA Vials 12/3/2018 7:00:00 PM Drug: Morphine PCA Vials, Revision Date: Tue, 04 Dec 2018 (Click for more...) Alpha-1 Proteinase Inhibitor 12/2/2018 7:00:00 PM Drug: Alpha-1 Proteinase Inhibitor, Revision Date: Mon, 03 Dec 2018 (Click for more...) Amino Acid Products 12/2/2018 7:00:00 PM Drug: Amino Acid Products, Revision Date: Mon, 03 Dec 2018 (Click for more...) Asparaginase Erwinia chrysanthemi 12/2/2018 7:00:00 PM Drug: Asparaginase Erwinia chrysanthemi, Revision Date: Mon, 03 Dec 2018 (Click for more...) Cefotaxime Sodium Injection 12/2/2018 7:00:00 PM Drug: Cefotaxime Sodium Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Furosemide Injection 12/2/2018 7:00:00 PM Drug: Furosemide Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Letermovir Injection 12/2/2018 7:00:00 PM Drug: Letermovir Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Potassium Acetate Injection 12/2/2018 7:00:00 PM Drug: Potassium Acetate Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Reteplase Injection 12/2/2018 7:00:00 PM Drug: Reteplase Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Granisetron Hydrochloride Injection 12/2/2018 7:00:00 PM Drug: Granisetron Hydrochloride Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Pamidronate Disodium Injection 12/2/2018 7:00:00 PM Drug: Pamidronate Disodium Injection, Revision Date: Mon, 03 Dec 2018 (Click for more...) Progesterone Injection 11/30/2018 7:00:00 PM Drug: Progesterone Injection, Revision Date: Sat, 01 Dec 2018 (Click for more...) Nalbuphine Injection 11/30/2018 7:00:00 PM Drug: Nalbuphine Injection, Revision Date: Sat, 01 Dec 2018 (Click for more...) Faculty receive HSC research awards 11/29/2018 12:00:00 AM Drs Gibson and Marsh recently attended the Pharmaceutical Sciences Departmental meeting to provide several of our faculty with HSC research awards. These were for efforts demonstrated by their individual studies and group research activities. Congratulations to Drs Du, McLaughlin, Hazlehurst, and Lockman! (Click for more...) WVU Medicine and Health Sciences to host holiday celebration for faculty and staff 11/29/2018 12:00:00 AM The annual Holiday Celebration for WVU Medicine and Health Sciences employees will kick off on Thurs., Dec. 6, from 2 to 4 p.m. at The Market, located on the ground floor of the Health Sciences Center. The Market will close at 11:30 a.m. for the celebration. (Click for more...) Small Biotechs Progressing Beyond Startup Status 11/28/2018 8:40:45 PM When is a startup no longer a startup? Small biotech companies armed with a talented crop of scientists have been springing up all across the pharma landscape for the last several years, establishing buzzing hubs of innovation. Not all of them find their research efforts successful, but many do and then go on to be […] (Click for more...) Multiple Electrolytes Large Volume Solutions for Injection 11/27/2018 7:00:00 PM Drug: Multiple Electrolytes Large Volume Solutions for Injection, Revision Date: Wed, 28 Nov 2018 (Click for more...) Rocuronium Injection 11/26/2018 7:00:00 PM Drug: Rocuronium Injection, Revision Date: Tue, 27 Nov 2018 (Click for more...) Tackling Unmet Needs with a Proprietary Platform 11/21/2018 10:21:38 PM Since our founding back in 2006, LegoChem Biosciences (LCB) has focused on the research and development of anti-biotic, anti-coagulant, anti-fibrosis and Antibody-Drug Conjugate (ADC) therapeutics based on our proprietary platform technology, LegoChemistry™ & Conjuall™. LCB is comprised of researchers who have varied backgrounds and R&D experiences, including the development of Factive, the first US FDA-approved drug […] (Click for more...) 0.9% Sodium Chloride Large Volume Bags 11/18/2018 7:00:00 PM Drug: 0.9% Sodium Chloride Large Volume Bags, Revision Date: Mon, 19 Nov 2018 (Click for more...) 0.9% Sodium Chloride Small Volume Bags (< 150 mL) 11/18/2018 7:00:00 PM Drug: 0.9% Sodium Chloride Small Volume Bags (< 150 mL), Revision Date: Mon, 19 Nov 2018 (Click for more...) 2% Lidocaine Hydrochloride Topical Jelly 11/18/2018 7:00:00 PM Drug: 2% Lidocaine Hydrochloride Topical Jelly, Revision Date: Mon, 19 Nov 2018 (Click for more...) 5% Dextrose Injection 11/18/2018 7:00:00 PM Drug: 5% Dextrose Injection, Revision Date: Mon, 19 Nov 2018 (Click for more...) 5% Dextrose Injection (PVC-free and DEHP-free) 11/18/2018 7:00:00 PM Drug: 5% Dextrose Injection (PVC-free and DEHP-free), Revision Date: Mon, 19 Nov 2018 (Click for more...) Belladonna and Opium Suppositories 11/18/2018 7:00:00 PM Drug: Belladonna and Opium Suppositories, Revision Date: Mon, 19 Nov 2018 (Click for more...) Ciprofloxacin Oral Suspension 11/18/2018 7:00:00 PM Drug: Ciprofloxacin Oral Suspension, Revision Date: Mon, 19 Nov 2018 (Click for more...) Lactated Ringer's Injection 11/18/2018 7:00:00 PM Drug: Lactated Ringer's Injection, Revision Date: Mon, 19 Nov 2018 (Click for more...) Potassium Chloride Injection 11/18/2018 7:00:00 PM Drug: Potassium Chloride Injection, Revision Date: Mon, 19 Nov 2018 (Click for more...) Sodium Fluoride Chewable Tablets 11/18/2018 7:00:00 PM Drug: Sodium Fluoride Chewable Tablets, Revision Date: Mon, 19 Nov 2018 (Click for more...) Sterile Water for Injection Large Volume Bags 11/18/2018 7:00:00 PM Drug: Sterile Water for Injection Large Volume Bags, Revision Date: Mon, 19 Nov 2018 (Click for more...) Cefpodoxime Oral Suspension 11/18/2018 7:00:00 PM Drug: Cefpodoxime Oral Suspension, Revision Date: Mon, 19 Nov 2018 (Click for more...) Protamine Injection 11/18/2018 7:00:00 PM Drug: Protamine Injection, Revision Date: Mon, 19 Nov 2018 (Click for more...) “Dear New Practitioner” 11/16/2018 12:12:35 PM “Dear New Practitioner” Mon, 11/18/2019 - 06:00 jdebruijn@APHA… Fri, 11/16/2018 - 12:12 There has been an increased effort to decrease mental health stigma and integrate mental health care into our lives like we would physical fitness. How do you as a new practitioner address mental health wit...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Stop the Bleed 11/16/2018 12:00:00 AM The Jon Michael Moore Trauma Center, in partnership with the American College of Surgeons, is taking part in the national "Stop the Bleed" initiative. Participants in the programs are being trained to stop bleeding in order to prevent death from hemorrhage. (Click for more...) PCA Sterile Empty Vials and Injector 11/15/2018 7:00:00 PM Drug: PCA Sterile Empty Vials and Injector, Revision Date: Fri, 16 Nov 2018 (Click for more...) Mafenide Acetate Powder for Solution 11/15/2018 7:00:00 PM Drug: Mafenide Acetate Powder for Solution, Revision Date: Fri, 16 Nov 2018 (Click for more...) Desiccated Thyroid Tablets 11/14/2018 7:00:00 PM Drug: Desiccated Thyroid Tablets, Revision Date: Thu, 15 Nov 2018 (Click for more...) Epinephrine Auto-Injectors 11/14/2018 7:00:00 PM Drug: Epinephrine Auto-Injectors, Revision Date: Thu, 15 Nov 2018 (Click for more...) Ranitidine Injection 11/14/2018 7:00:00 PM Drug: Ranitidine Injection, Revision Date: Thu, 15 Nov 2018 (Click for more...) Ciprofloxacin Injection 11/13/2018 7:00:00 PM Drug: Ciprofloxacin Injection, Revision Date: Wed, 14 Nov 2018 (Click for more...) Amino Acid Products with Electrolytes and Calcium 11/13/2018 7:00:00 PM Drug: Amino Acid Products with Electrolytes and Calcium, Revision Date: Wed, 14 Nov 2018 (Click for more...) Amino Acids in Dextrose 11/13/2018 7:00:00 PM Drug: Amino Acids in Dextrose, Revision Date: Wed, 14 Nov 2018 (Click for more...) Fluphenazine Tablets 11/11/2018 7:00:00 PM Drug: Fluphenazine Tablets, Revision Date: Mon, 12 Nov 2018 (Click for more...) Methyldopa Tablets 11/11/2018 7:00:00 PM Drug: Methyldopa Tablets, Revision Date: Mon, 12 Nov 2018 (Click for more...) Penicillamine 11/11/2018 7:00:00 PM Drug: Penicillamine, Revision Date: Mon, 12 Nov 2018 (Click for more...) Dexrazoxane Injection 11/8/2018 7:00:00 PM Drug: Dexrazoxane Injection, Revision Date: Fri, 09 Nov 2018 (Click for more...) 5% Lidocaine and 7.5% Dextrose Injection 11/7/2018 7:00:00 PM Drug: 5% Lidocaine and 7.5% Dextrose Injection, Revision Date: Thu, 08 Nov 2018 (Click for more...) Norepinephrine Bitartrate Injection 11/7/2018 7:00:00 PM Drug: Norepinephrine Bitartrate Injection, Revision Date: Thu, 08 Nov 2018 (Click for more...) Pharmacy researcher leads the future of experimental therapeutics at WVU 11/7/2018 12:00:00 AM Researchers across campus are taking a One WVU approach to solving important problems and saving lives. At its core, an experimental therapeutics platform that integrates multiple disciplines from chemistry and biology to the health sciences and cancer institute. (Click for more...) Aminocaproic Acid Injection 11/5/2018 7:00:00 PM Drug: Aminocaproic Acid Injection, Revision Date: Tue, 06 Nov 2018 (Click for more...) WVU's chapter of APhA-ASP wins regional award for heart disease awareness 11/5/2018 12:00:00 AM Congratulations to the WVU School of Pharmacy's Chapter of the American Pharmacists Association – Academy of Student Pharmacists (APhA-ASP)! They earned the 2017-2018 region two award for Operation Heart activities. The award was presented this weekend at the association's Midyear Regional Meetings in Baltimore, Maryland. Operation Heart, a program to create awareness of cardiovascular disease, was launched as an official APhA-ASP National Patient Care project in 2010. Through participation in Operation Heart, student pharmacists work in their communities to encourage lifestyle modifications, monitor associated risk factors and provide education about medications for heart disease. APhA-ASP Region two includes schools of pharmacy from West Virginia, Pennsylvania, Virginia, Washington, D.C., Maryland, Delaware, and New Jersey. (Click for more...) Erythromycin Lactobionate Injection 11/4/2018 7:00:00 PM Drug: Erythromycin Lactobionate Injection, Revision Date: Mon, 05 Nov 2018 (Click for more...) Blue Zones Project WVU transformation presentation and Food and Friends @ 5 celebration 11/4/2018 12:00:00 AM Join Blue Zones Project Wednesday, Nov. 14, for a presentation by national speaker Nick Buettner about improving well-being across campus. The event will be held from 5:00 to 7 p.m. at the Erickson Alumni Center. Refreshments and healthy snacks provided. (Click for more...) Isocarboxazid Tablets 11/1/2018 8:00:00 PM Drug: Isocarboxazid Tablets, Revision Date: Fri, 02 Nov 2018 (Click for more...) Liotrix (Levothyroxine/Liothyronine T4/T3) 10/31/2018 8:00:00 PM Drug: Liotrix (Levothyroxine/Liothyronine T4/T3), Revision Date: Thu, 01 Nov 2018 (Click for more...) Estradiol Valerate Injection 10/31/2018 8:00:00 PM Drug: Estradiol Valerate Injection, Revision Date: Thu, 01 Nov 2018 (Click for more...) 2019 Van Liere Research Conference 10/31/2018 12:00:00 AM The 54th Annual Van Liere Research Conference (formerly the E.J. Van Liere Convocation and HSC Research Day) will be held on March 21st and 22nd, 2019 on the WVU Health Sciences Campus in Morgantown, WV. (Click for more...) Leuprolide Acetate 14-Day Kit 10/29/2018 8:00:00 PM Drug: Leuprolide Acetate 14-Day Kit, Revision Date: Tue, 30 Oct 2018 (Click for more...) Ethiodized Oil 10/24/2018 8:00:00 PM Drug: Ethiodized Oil, Revision Date: Thu, 25 Oct 2018 (Click for more...) Yellow Fever Vaccine 10/24/2018 8:00:00 PM Drug: Yellow Fever Vaccine, Revision Date: Thu, 25 Oct 2018 (Click for more...) WVU grad student collaborates with pharmacy professor to pursue drug to treat aggressive form of blood cancer 10/24/2018 12:00:00 AM Multiple myeloma doesn't play around. Within five years of being diagnosed with this form of blood cancer, about half of all patients die from it. And even if they initially respond well to treatment, the cancer can hide in their bone marrow for years before reemerging in a tougher-to-treat form. (Click for more...) Chlorothiazide Sodium Injection 10/22/2018 8:00:00 PM Drug: Chlorothiazide Sodium Injection, Revision Date: Tue, 23 Oct 2018 (Click for more...) Health Sciences Campus to host Mountaineer Week events 10/17/2018 12:00:00 AM Mountaineer Week, WVU's annual celebration of West Virginia heritage and culture, will make a stop at the Health Sciences Campus on Wednesday, Oct. 24, from 11 a.m. – 1 p.m. on the Learning Center Green. (Click for more...) Du Publishes Two Studies That Describe an Improved Approach to Bone Marrow Transplant 10/10/2018 12:00:00 AM WVU cancer researcher and Assistant Professor of Pharmaceutical Sciences Wei Du, MD, PhD, teamed up with researchers from Cincinnati Children's Hospital Medical Center to focus on improving outcomes and reducing side effects of traditional stem cell transplant. Their work was recently published in Leukemia, one of the top journals in hematology. (Click for more...) NIH awards WVU $11.2 million for interdisciplinary cancer research 10/10/2018 12:00:00 AM West Virginia University's School of Pharmacy will soon become one of the few pharmacy schools in the nation that leads a center of biomedical research excellence. Funded by the National Institutes of Health, these centers support interdisciplinary, thematically related research into preventing, diagnosing and treating health problems. (Click for more...) Mitomycin Kit for Ophthalmic Use 10/8/2018 8:00:00 PM Drug: Mitomycin Kit for Ophthalmic Use, Revision Date: Tue, 09 Oct 2018 (Click for more...) WVU community invited to State of the University address today (10/8) 10/8/2018 12:00:00 AM WVU President Gordon Gee will deliver a State of the University address today (Oct. 8) at 3:15 p.m. at the Ruby Grand Hall, Erickson Alumni Center. Faculty, staff and students are encouraged to use the PRT, buses or carpool to the event. (Click for more...) SoP students collect empty Coca-Cola products to help WVU Medicine Children's 10/5/2018 12:00:00 AM The Industry Pharmacist Organization (IPhO) chapter at WVU started with one can and built a mountain. They've been collecting the empty Coca-Cola cans and bottles to raise money for WVU Medicine Children's. For each can or bottle donated, Coca-Cola is donating $5! The drive will continue until 3 p.m. today. Thanks to everyone at the Health Sciences Center for participating. #Let'sGo! (Click for more...) Prothrombin Complex Concentrate (Kcentra) 10/3/2018 8:00:00 PM Drug: Prothrombin Complex Concentrate (Kcentra), Revision Date: Thu, 04 Oct 2018 (Click for more...) WVU APhA-ASP celebrates American Pharmacists Month 10/2/2018 12:00:00 AM October is American Pharmacists Month. WVU APhA-ASP and other student organizations will sponsor an entire month full of events to help celebrate the profession. Check out the list below and mark your calendar. (Click for more...) Pharmaceutical and Pharmacological Sciences Seminar Series 10/2/2018 12:00:00 AM Please join the West Virginia University School of Pharmacy on Oct. 9 at 1:00 p.m. in Room 3084 HSC-N for the Pharmaceutical and Pharmacological Sciences Seminar Series. John D. Imig, Ph.D., will present, "Eicosanoid Drugs: Prospects for Treating Human Diseases." Imig is a professor of pharmacology and toxicology as well as director of the Drug Discovery Center at the Medical College of Wisconsin. (Click for more...) Fomepizole Injection 10/1/2018 8:00:00 PM Drug: Fomepizole Injection, Revision Date: Tue, 02 Oct 2018 (Click for more...) 3% and 5% Sodium Chloride Large Volume Injection 9/30/2018 8:00:00 PM Drug: 3% and 5% Sodium Chloride Large Volume Injection, Revision Date: Mon, 01 Oct 2018 (Click for more...) Dipyridamole Injection 9/30/2018 8:00:00 PM Drug: Dipyridamole Injection, Revision Date: Mon, 01 Oct 2018 (Click for more...) First-year pharmacy students discuss the importance of cultural awareness in healthcare 9/27/2018 12:00:00 AM Fasting is a common practice in many religions, but what if a patient's religious beliefs keep him or her from taking a life-saving medication? How do pharmacists work around language barriers? To create cultural awareness among first-year students (P-1) and help them to navigate related challenges in a professional, caring way, the WVU School of Pharmacy has incorporated a new activity into the P-1 curriculum that addresses culture and diversity. (Click for more...) Pharmacy alumnus among homecoming awardees to be honored for extraordinary service to WVU 9/27/2018 12:00:00 AM In just 10 years, School of Pharmacy alumnus Dr. Brian Lawson (PharmD, 2008) has already provided what some would consider a lifetime of service to his alma mater. On Oct. 6, Mountaineer Nation will applaud his dedication as he accepts a prestigious award from the WVU Alumni Association during halftime of the WVU/Kansas Homecoming game. (Click for more...) Cyclosporine Capsules 9/26/2018 8:00:00 PM Drug: Cyclosporine Capsules, Revision Date: Thu, 27 Sep 2018 (Click for more...) WVU alumnus earns national award for service to the pharmacy profession 9/26/2018 12:00:00 AM The National Association of Chain Drug Stores is recognizing School of Pharmacy alumnus Mike Podgurski (BS Pharmacy, 1972) with its highest honor. Podgurski is the 2018 recipient of the Harold W. Pratt Award which recognizes individuals whose activities have contributed to the promotion, recognition and improvement of the practice of pharmacy in the chain pharmacy setting. (Click for more...) Lorazepam Oral Solution 9/25/2018 8:00:00 PM Drug: Lorazepam Oral Solution, Revision Date: Wed, 26 Sep 2018 (Click for more...) Moxifloxacin Injection 9/24/2018 8:00:00 PM Drug: Moxifloxacin Injection, Revision Date: Tue, 25 Sep 2018 (Click for more...) Free health screenings and prize opportunities at the Mountainlair 9/24/2018 12:00:00 AM Flu shots, Hemoglobin A1C tests, free health care screenings and prize opportunities will be available at the WVU Healthy Living Fair at the Mountainlair on Thursday, Sept. 27 from 10 a.m.– 2 p.m. (Click for more...) Health Sciences to host "Pandemics and Vaccinations" Expert Panel on Oct. 9 9/24/2018 12:00:00 AM Reality or fiction – just how likely is a pandemic illness? Join leading health experts as they discuss the reality of a pandemic illness on Tuesday, Oct. 9, at 4 p.m. at the Health Sciences Center's Okey Patteson Auditorium. (Click for more...) It's a "Code Blue" at the WVU Health Sciences Center as students train for cardiac arrest patients 9/14/2018 12:00:00 AM Witness WVU Health Sciences students and local emergency services professionals perform a "Code Blue" emergency response to a simulated cardiac arrest situation as part of National Healthcare Simulation Week. (Click for more...) Kappa Psi members receive international recognition for their academic achievments 9/12/2018 12:00:00 AM The largest professional pharmacy fraternity in the world is celebrating a group of students at the West Virginia University School of Pharmacy for their outstanding academic achievements. (Click for more...) Atenolol tablets 9/10/2018 8:00:00 PM Drug: Atenolol tablets, Revision Date: Tue, 11 Sep 2018 (Click for more...) WVU pharmacy professor to present at country's largest pain management conference 9/7/2018 12:00:00 AM Healthcare professionals attending the largest pain management conference in the United States may learn a thing or two about treating pain the "West Virginia Way." (Click for more...) WVU School of Pharmacy announces plans for Homecoming 2018 9/6/2018 12:00:00 AM The WVU School of Pharmacy will welcome alumni back to Morgantown the first weekend in October for Homecoming festivities. (Click for more...) Lidocaine Hydrochloride and 5% Dextrose Injection 9/5/2018 8:00:00 PM Drug: Lidocaine Hydrochloride and 5% Dextrose Injection, Revision Date: Thu, 06 Sep 2018 (Click for more...) Gillison to present Annual DeLynn Lecture 8/30/2018 12:00:00 AM The WVU Cancer Institute will hold its Annual DeLynn Lecture with Maura L. Gillison, MD, PhD, who will lecture on HPV and the Host Genome, at 4 pm on Tuesday, Sept. 4, in the WVU Health Sciences Center's Fukushima Auditorium (room 1901). A Q&A session will follow the lecture. The event is free and open to the public. For those who cannot attend, the event also will be webcast. (Click for more...) SoP alumni and faculty win awards at WVPA Convention 8/29/2018 12:00:00 AM Four West Virginia University School of Pharmacy alumni and two faculty members received awards at the 111th annual West Virginia Pharmacy Association (WVPA) Convention. (Click for more...) Vincristine Sulfate Injection 8/27/2018 8:00:00 PM Drug: Vincristine Sulfate Injection, Revision Date: Tue, 28 Aug 2018 (Click for more...) WVU Pharmacy students receive white coats 8/27/2018 12:00:00 AM Members of the West Virginia UniversitySchool of Pharmacy Class of 2022 recently received the most significant symbol of their graduate career — the white coat. (Click for more...) Atropine Ophthalmic Solution 8/26/2018 8:00:00 PM Drug: Atropine Ophthalmic Solution, Revision Date: Mon, 27 Aug 2018 (Click for more...) WVU in the news: WVU researchers working to stop cancer-growth protein 8/23/2018 12:00:00 AM Yehenew Agazie, an associate professor of biochemistry at the WVU School of Medicine, received a $1.6 million grant from the National Institutes of Health to investigate a new breast cancer treatment that is especially effective against recurrent tumors. (Click for more...) Postdoc Appreciation Event 8/23/2018 12:00:00 AM On September 18th, the Office of Research and Graduate Education will host the annual Postdoc Appreciation Celebration during the National Postdoc Appreciation week. (Click for more...) WVU Pharmacy students are winning! 8/21/2018 12:00:00 AM On August 18, four third-year students showed off their self-care knowledge at the annual West Virginia Pharmacists Association meeting in Charleston. The team comprised of Lindsay Mason, Mai Do, Lucy Luo and Shaina Kopelov won the Student Pharmacist Self Care Championship. They competed against a team from Marshall University School of Pharmacy in a jeopardy style game. The students were challenged to identify and explain aspects of the effective and safe practice of pharmacy self-care treatments. In additiion, they were asked to identify at least two over-the-counter prescription medication interactions that pharmacists should be aware of, and list three OTC medications and their use. (Click for more...) Nitroglycerin Injection 8/11/2018 8:00:00 PM Drug: Nitroglycerin Injection, Revision Date: Sun, 12 Aug 2018 (Click for more...) Multiple Vitamin Oral Liquid 8/7/2018 8:00:00 PM Drug: Multiple Vitamin Oral Liquid, Revision Date: Wed, 08 Aug 2018 (Click for more...) Selenium Injection (as Selenious Acid) 8/5/2018 8:00:00 PM Drug: Selenium Injection (as Selenious Acid), Revision Date: Mon, 06 Aug 2018 (Click for more...) Amoxicillin and Clavulanate 1000 mg/62.5 mg Extended-Release Tablets 7/31/2018 8:00:00 PM Drug: Amoxicillin and Clavulanate 1000 mg/62.5 mg Extended-Release Tablets, Revision Date: Wed, 01 Aug 2018 (Click for more...) Flurbiprofen Sodium Ophthalmic Solution 7/30/2018 8:00:00 PM Drug: Flurbiprofen Sodium Ophthalmic Solution, Revision Date: Tue, 31 Jul 2018 (Click for more...) Doctors target opioid epidemic by learning new approaches to pain treatment 7/19/2018 12:00:00 AM MORGANTOWN, W.Va. – Twice a month, healthcare providers from rural health centers all across West Virginia meet in a virtual classroom to discuss how best to help their patients cope with chronic pain. (Click for more...) Ipratropium Bromide Metered-Dose Inhaler 7/8/2018 8:00:00 PM Drug: Ipratropium Bromide Metered-Dose Inhaler, Revision Date: Mon, 09 Jul 2018 (Click for more...) Thiamine Injection 7/5/2018 8:00:00 PM Drug: Thiamine Injection, Revision Date: Fri, 06 Jul 2018 (Click for more...) Caffeine and Sodium Benzoate Injection 7/4/2018 8:00:00 PM Drug: Caffeine and Sodium Benzoate Injection, Revision Date: Thu, 05 Jul 2018 (Click for more...) Trace Elements Injection 7/4/2018 8:00:00 PM Drug: Trace Elements Injection, Revision Date: Thu, 05 Jul 2018 (Click for more...) Vitamin K (Phytonadione) Injection 7/4/2018 8:00:00 PM Drug: Vitamin K (Phytonadione) Injection, Revision Date: Thu, 05 Jul 2018 (Click for more...) Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution 6/26/2018 8:00:00 PM Drug: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, Revision Date: Wed, 27 Jun 2018 (Click for more...) Three West Virginia pharmacists named WVU School of Pharmacy's Preceptor of the Year 6/26/2018 12:00:00 AM Bill Renner, Terry Davis and Matt Pletcher received the 2018 WVU School of Pharmacy Preceptor of the Year award on Friday, June 8 at the School's annual Alumni Reunion Dinner. (Click for more...) School of Pharmacy DAP student wins national history award 6/25/2018 12:00:00 AM School of Pharmacy Direct Admit Pathway (DAP) student Brennan Lawless is off to a fast start as a West Virginia University freshman. The Daniels, West Virginia, native recently won a National History Day award. (Click for more...) Dalbavancin Injection 6/20/2018 8:00:00 PM Drug: Dalbavancin Injection, Revision Date: Thu, 21 Jun 2018 (Click for more...) Asparaginase Erwinia chrysanthemi 6/19/2018 8:00:00 PM Drug: Asparaginase Erwinia chrysanthemi, Revision Date: Wed, 20 Jun 2018 (Click for more...) Haloperidol Lactate Injection 6/19/2018 8:00:00 PM Drug: Haloperidol Lactate Injection, Revision Date: Wed, 20 Jun 2018 (Click for more...) New rural scholars program available to health professions students in West Virginia 6/14/2018 12:00:00 AM West Virginia AHEC Rural Community Health Scholars is a new, highly selective program available to 75 of West Virginia's top health professions students interested in practicing in rural or underserved communities; WVU and non-WVU students alike may participate. (Click for more...) WVU researchers identify four factors that predict chronic opioid use 5/29/2018 12:00:00 AM Four factors increase the odds that a patient will wind up on chronic opioid therapy, suggests research conducted by a team of researchers led by Nilanjana Dwibedi, assistant professor in the West Virginia University School of Pharmacy. (Click for more...) Amoxapine Tablets 5/28/2018 8:00:00 PM Drug: Amoxapine Tablets, Revision Date: Tue, 29 May 2018 (Click for more...) Oseltamivir Oral Suspension 5/28/2018 8:00:00 PM Drug: Oseltamivir Oral Suspension, Revision Date: Tue, 29 May 2018 (Click for more...) Penicillin G Benzathine / Penicillin G Procaine 5/24/2018 8:00:00 PM Drug: Penicillin G Benzathine / Penicillin G Procaine, Revision Date: Fri, 25 May 2018 (Click for more...) Pantoprazole Injection 5/22/2018 8:00:00 PM Drug: Pantoprazole Injection, Revision Date: Wed, 23 May 2018 (Click for more...) Doxycycline Hyclate Injection 5/20/2018 8:00:00 PM Drug: Doxycycline Hyclate Injection, Revision Date: Mon, 21 May 2018 (Click for more...) Thiotepa for Injection 5/13/2018 8:00:00 PM Drug: Thiotepa for Injection, Revision Date: Mon, 14 May 2018 (Click for more...) School of Pharmacy announces changes to its leadership team 5/10/2018 12:00:00 AM The West Virginia University School of Pharmacy is pleased to announce changes to its leadership team. Dr. Paul Lockman has been appointed the position of senior associate dean for research and strategic initiatives in addition to Mylan Endowed Chair of Pharmacology, while Dr. Mary Stamatakis has been appointed to senior associate dean of academic affairs and educational innovation. (Click for more...) 25% Dextrose Injection 5/9/2018 8:00:00 PM Drug: 25% Dextrose Injection, Revision Date: Thu, 10 May 2018 (Click for more...) Scopolamine Transdermal System 5/7/2018 8:00:00 PM Drug: Scopolamine Transdermal System, Revision Date: Tue, 08 May 2018 (Click for more...) MEET OUR GRADS: Erin Barthelmess 5/3/2018 12:00:00 AM Why did you choose WVU? (Click for more...) MEET OUR GRADS: Jonathan Boyles 5/3/2018 12:00:00 AM Why did