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POCT Certificate Program

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

 

WVSHP Annual Meeting: A Focus on Substance Abuse Annual Meeting: A Focus on Substance Abuse April 26-27, 2019 EMBASSY SUITES CHARLESTON 305 Court St, Charleston, WV 25301 (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...
State of Washington made progress toward achieving program goals for enhancing its PDMP 4/22/2019 2:11:15 PM State of Washington made progress toward achieving program goals for enhancing its PDMP Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 The HHS Office of Inspector General has identified actions that the state of Washington has taken, using federal funds for improving prescription drug monitoring programs (PDMPs), to achieve program goals toward improving safe prescribing practices and preventing prescription drug abuse and misuse. As of July 2018, Washington had completed some of the activities it proposed for the CDC grant to enhance and maximize its PDMP. Specifically, of the 11 activities proposed for the audit period (March 1, 2016, through August 31, 2017), six were completed, and the remaining five were partially completed. Washington complied with federal requirements for submitting its Federal Financial Report and Annual Performance Report and publicly reporting the five CDC-directed indicators (required for awardees using PDMPs for public health surveillance). (Click for more...) Bill aims to allow more flexibility for prescription drug spending 4/22/2019 2:11:13 PM Bill aims to allow more flexibility for prescription drug spending Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 The Restoring Access to Medication Act (RAMA) was recently introduced in the U.S. Senate and aims to reverse a provision in the Affordable Care Act (ACA) that limits the use of funds from pre-tax health accounts, allowing consumers to have more flexibility when purchasing prescription drugs or OTC drugs. "No one should have to choose between groceries and getting the medication they need because drug prices are too high, which is why I introduced this bill to help address this issue," said Sen. Joe Manchin, (D-WV), a sponsor of the bill. "I hope that my colleagues, both Democrat and Republican, will support this bill so that we can make improvements to our health care system." (Click for more...) CMS rule aims to block use of drugmaker coupons on ACA plan members' out-of-pocket costs 4/22/2019 2:11:11 PM CMS rule aims to block use of drugmaker coupons on ACA plan members' out-of-pocket costs Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 CMS on April 18 filed a new rule that includes a provision to allow insurers in the Affordable Care Act's (ACA) 2020 plan year to implement copay accumulator programs that would block the use of manufacturer coupons to lower annual out-of-pocket costs on certain brand name drugs when there is a generic available. Virginia and West Virginia have banned these programs in their individual markets, and several additional states are considering similar moves. CMS has argued that the practice would decrease drug spending and encourage people to use generics. The agency reiterated its support for a legislative fix to end ACA plan "silver-loading," including the potential for cost-sharing reduction payments to be reinstated. CMS is also considering changes for automatic re-enrollment in 2021, according to the rule, expressing concern that the current form of re-enrollment may prevent plan members from updating their information in a timely manner, which could lead to wasteful spending on tax credits. All commenters that weighed-in on the issue called for CMS to leave the current re-enrollment policy in place, as it eases administrative burden and can prevent lapses in coverage. CMS said it will consider those responses as "we continue to explore options to improve exchange program integrity." (Click for more...) 340B program may hinder access to costly drugs as hospitals exploit discounts: CRE 4/22/2019 2:11:11 PM 340B program may hinder access to costly drugs as hospitals exploit discounts: CRE Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 A report from the Center for Regulatory Effectiveness (CRE) suggests that the 340B drug discount program may affect patient access to costly drugs. CRE found that the number of uninsured, impoverished patients without access to medical care and dental care grew between 2009 and 2015, even as the overall number of 340B hospitals more than tripled. According to the review, 340B qualifying patients were prescribed more medication and costlier drugs than patients being cared for by non-340B providers. The report also discovered that 340B hospitals charge at least twice as much for outpatient oncology care as non-340B providers. 340B Health, a group that represents 1,300 hospitals in the program, wrote in a blog post that some 340B providers, particularly safety-net and rural hospitals, would be forced to slash services without the discounts they earn in the program. However, CRE's report asserted that the program resulted in increased inequality in the health care system, changed treatment protocols to maximize hospital's drug profits, and worsened medical outcomes for the impoverished and uninsured. "What really struck me is that the medically underserved communities are the ones that are failing. The bottom is really falling away from the middle," said CRE's Bruce Levinson. (Click for more...) IBM stops development, sales of Watson for drug discovery 4/22/2019 2:11:11 PM IBM stops development, sales of Watson for drug discovery Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 Citing inadequate financial performance, IBM has discontinued the development and sales of its Watson for Drug Discovery product. IBM's Watson artificial intelligence (AI) software for this product was introduced in 2014, with the goal of helping pharmaceutical companies develop new drugs. Sanofi, Johnson & Johnson, and Pfizer were among the firms that formed partnerships with the research tool. IBM will no longer market or advance Watson for Drug Discovery, but will continue to serve pharmaceutical companies already using the software, says IBM spokesperson Edward Barbini. He adds, "We are focusing our resources within Watson Health to double down on the adjacent field of clinical development where we see an even greater market need for our data and AI capabilities." (Click for more...) Measles in 2019 -- Going backward 4/22/2019 2:11:10 PM Measles in 2019 -- Going backward Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 America's successful eradication of measles at the start of the century appears to be reversing, with CDC documenting at least 555 cases in 20 states so far this year. Immunization efforts were widely credited for the 2000 accomplishment, and the current series of localized outbreaks are blamed on transmissions from infected travelers who then spread the virus to undervaccinated subsets of the U.S. population. Measles is preventable through vaccination, note Anthony S. Fauci and Hilary D. Marston of the National Institute of Allergy and Infectious Diseases, who warn that additional setbacks on this front could be devastating. The disease could return en masse, they write with infectious disease specialist Catharine I. Paulis of Penn State. And while generally contained in the past to younger pediatric populations—who are now largely protected from the virus—a measles resurgence would likely target new and more vulnerable segments of the public, including older children, cancer and HIV patients, immunocompromised individuals, expecting mothers, and other adults. The limited data out there on the subject, the authors report, suggest that morbidity and mortality rates would be greater among these patients. Needless infections, complications, and even deaths can be avoided, they conclude, by full acceptance and uptake of measles vaccination, which is both safe and effective. (Click for more...) J&J's new ketamine-like depression drug off to 'very, very strong start,' company says 4/22/2019 2:11:10 PM J&J's new ketamine-like depression drug off to 'very, very strong start,' company says Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 As many as 800 health centers have been approved to administer esketamine (Spravato—Johnson & Johnson), a ketamine-like depression drug recently cleared by FDA. Esketamine is already being used by patients for treatment-resistant depression, the company says. The drug is similar to ketamine, a sedative that is increasingly being studied and used to treat depression. Esketamine's side effects include sedation and dissociation, and there is a potential for misuse and abuse. As a result, the FDA stipulated that esketamine must be administered in a medically supervised health care setting where patients are monitored. Pharmacies, doctor's offices, and clinics also must be certified. The certification of up to 800 sites puts Johnson & Johnson "well on track" with its plans for the year, says Jennifer Taubert, executive vice president of pharmaceuticals. She adds that a number of patients have received their first dose, with some receiving multiple doses. (Click for more...) Walgreens, SmileDirectClub partner on SmileShop pilot 4/22/2019 2:11:10 PM Walgreens, SmileDirectClub partner on SmileShop pilot Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 Walgreens and SmileDirectClub are partnering to test SmileShops within four Walgreens stores in four markets. Under the pilot program, teeth-straightening solutions will be available in Walgreens locations in Tampa and Orlando, FL; Cleveland, OH; and Tempe, AZ. The SmileShops in Walgreens will include an on-site SmileGuide to help consumers with a free 3-D scan of their teeth and to introduce them to the invisible aligner therapy. Following the visit, a licensed SmileDirectClub dentist or orthodontist approves and manages the individual's alignment treatment plan, with aligners shipped directly to the customer, with round-the-clock chat, email, and phone assistance available. (Click for more...) Two-wave U.S influenza season is now the longest in a decade 4/22/2019 2:11:08 PM Two-wave U.S influenza season is now the longest in a decade Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 CDC reported Friday that the current influenza season has lasted for 21 weeks. While the influenza season initially seemed like it would be short and mild, a second viral wave has made it the longest in a decade. The season started around Thanksgiving with a more mild strain; however, in February, a more potent viral strain began causing more illnesses and more hospitalizations. Still, according to CDC's Lynnette Brammer, there are indications that the influenza season should be over soon, as long as nothing changes. CDC estimates that influenza-related deaths this season could total 35,000–55,000. In the 2017–18 season, an estimated 80,000 people died from influenza and its complications. (Click for more...) FDA permits marketing of first medical device for treatment of ADHD 4/22/2019 2:11:08 PM FDA permits marketing of first medical device for treatment of ADHD Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 The first medical device to treat ADHD received FDA approval on Friday. The Monarch external Trigeminal Nerve Stimulation (eTNS) System, a prescription-only device from NeuroSigma, is indicated for individuals aged 7–12 years who are not currently taking prescription ADHD medication. "This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind," said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices in FDA's Center for Devices and Radiological Health. The cellphone-sized device is to be used in the home under the supervision of a caregiver during periods of sleep. It generates a low-level electrical pulse and connects using a wire to a small patch placed on the patient's forehead. The electrical stimulation—which should feel like a tingling sensation on the skin—is delivered to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. The most common adverse effects observed with the new device are drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache, and fatigue. FDA reviewed the eTNS system through the de novo premarket review pathway. (Click for more...) Closed-loop insulin delivery may improve glycemic control in patients on nutritional support 4/22/2019 2:11:08 PM Closed-loop insulin delivery may improve glycemic control in patients on nutritional support Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 New evidence supports the use of fully closed-loop insulin delivery for improving glycemic control among adults receiving parenteral and/or enteral nutrition during their hospital stay. The trial, conducted in non-critical care settings in the United Kingdom and Switzerland, compared outcomes using the technique with outcomes using traditional insulin therapy. All 43 study participants were outfitted with a cannula that delivered insulin and a real-time continuous glucose monitoring sensor placed under the skin of the arm or abdomen. During followup of 15 days or until hospital discharge, glucose levels held in the target range 68.4% of the time for the 21 closed-loop insulin recipients but only 36.4% of the time for the 22 controls. The researchers, reporting in The Lancet Diabetes and Endocrinology, also noted that no treatment-related adverse events and no episodes of severe hypoglycemia or hyperglycemia with ketonemia were documented in any of the study participants. (Click for more...) FDA approves first generic naloxone nasal spray to treat opioid overdose 4/22/2019 2:11:06 PM FDA approves first generic naloxone nasal spray to treat opioid overdose Sun, 04/21/2019 - 20:00 cbaker_admin Mon, 04/22/2019 - 14:11 FDA on Friday gave final approval of the first generic naloxone hydrochloride nasal spray (Teva Pharmaceuticals USA). The agency gave tentative approval to this generic drug product in June 2018. Generic injectable naloxone products have been used for years in health care settings, but this is the first generic naloxone nasal spray for use in a community setting by those without medical training. FDA said it would take measures to prioritize its review of additional generic drug applications for naloxone. "FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an OTC naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be coprescribed with all or some opioid prescriptions to reduce the risk of overdose death," said Douglas Throckmorton, MD, deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research. According to CDC, nearly 400,000 people died from an opioid overdose from 1999 to 2017. (Click for more...) Novartis unveils investigation of infant's death in European Zolgensma trial 4/22/2019 11:19:23 AM On the cusp of Zolgensma's landmark FDA approval, Novartis has big hopes for the first-ever gene therapy for spinal muscular atrophy. But a patient’s death in the treatment's European trial could throw a wrench into its plans. (Click for more...) Alvogen recalls mismarked fentanyl patches over overdose concerns 4/22/2019 10:46:28 AM The highly effective but highly addictive properties of fentanyl have made it a drug that has figured prominently in national concerns over opioid addiction. A drugmaker is now recalling two lots of mismarked fentanyl patches because they could lead to overdoses. (Click for more...) Merck heaps early pressure on Bristol-Myers' Opdivo with Keytruda's kidney cancer debut 4/22/2019 10:24:48 AM Bristol-Myers Squibb investors knew trouble would come for Opdivo when Merck’s Keytruda entered the kidney cancer arena, but that trouble just arrived two months early. (Click for more...) Torrent recalls more than 1M bottles of tainted blood pressure meds 4/22/2019 9:37:08 AM The recall from the U.S. of tainted blood pressure medicines reached new heights as India’s Torrent Pharmaceuticals recalled 104 lots of losartan over the weekend because they contained an impurity suspected of causing cancer. (Click for more...) Amgen tones down TV ad for Repatha with disco music and wedding revelry 4/22/2019 7:38:40 AM Amgen brings back its imaginary ambulance workers in a new TV ad for cholesterol fighter Repatha, but the latest spot adds dancing and disco music—and eases up on the foreboding—to lighten the mood. The ad follows list-price cuts on Repatha and its head-to-head PCSK9 rival Praluent. (Click for more...) SoP professor emeritus, loyal WVU supporter, passes away 4/22/2019 12:00:00 AM Dr. Art Jacknowitz, professor emeritus and tireless supporter of the university, has passed away following a valient battle with cancer - he was 75 year old. (Click for more...) 5% Lidocaine and 7.5% Dextrose Injection 4/21/2019 8:00:00 PM Drug: 5% Lidocaine and 7.5% Dextrose Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Amphotericin B Injection 4/21/2019 8:00:00 PM Drug: Amphotericin B Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Cefazolin Injection 4/21/2019 8:00:00 PM Drug: Cefazolin Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Cefuroxime Sodium Injection 4/21/2019 8:00:00 PM Drug: Cefuroxime Sodium Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Hydralazine injection 4/21/2019 8:00:00 PM Drug: Hydralazine injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Hydromorphone Hydrochloride Injection 4/21/2019 8:00:00 PM Drug: Hydromorphone Hydrochloride Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Lidocaine Injection 4/21/2019 8:00:00 PM Drug: Lidocaine Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Lidocaine with Epinephrine Injection 4/21/2019 8:00:00 PM Drug: Lidocaine with Epinephrine Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Morphine PCA Vials 4/21/2019 8:00:00 PM Drug: Morphine PCA Vials, Revision Date: Mon, 22 Apr 2019 (Click for more...) Multiple Vitamins for Infusion 4/21/2019 8:00:00 PM Drug: Multiple Vitamins for Infusion, Revision Date: Mon, 22 Apr 2019 (Click for more...) Pantoprazole Injection 4/21/2019 8:00:00 PM Drug: Pantoprazole Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) PCA Sterile Empty Vials and Injector 4/21/2019 8:00:00 PM Drug: PCA Sterile Empty Vials and Injector, Revision Date: Mon, 22 Apr 2019 (Click for more...) Promethazine Injection 4/21/2019 8:00:00 PM Drug: Promethazine Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Sodium Bicarbonate Injection 4/21/2019 8:00:00 PM Drug: Sodium Bicarbonate Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Thiamine Injection 4/21/2019 8:00:00 PM Drug: Thiamine Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) Calcium Gluconate Injection 4/21/2019 8:00:00 PM Drug: Calcium Gluconate Injection, Revision Date: Mon, 22 Apr 2019 (Click for more...) High-deductible health policies linked to delayed diagnosis and treatment 4/20/2019 2:05:01 AM High-deductible health policies linked to delayed diagnosis and treatment Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 New research shows a connection between high-deductible health policies and delayed diagnosis and treatment for breast cancer care. According to the data, women with low incomes who had high-deductible insurance plans waited an average of 1.6 months longer for diagnostic breast imaging, 2.7 months for first biopsy, 6.6 months for first early-stage breast cancer diagnosis, and 8.7 months for first chemotherapy, compared with low-income women with low-deductible plans. The Health Affairs study also found that women with high incomes who relied on high-deductible health plans also faced delays, experiencing lags of 0.7 months for first breast imaging, 1.9 months for first biopsy, 5.4 months for first early-stage breast cancer diagnosis, and 5.7 months for first chemotherapy, compared with high-income women with low-deductible plans. The researchers found that having a high-deductible health plan was linked to delays in care irrespective of the size of the patient's town or city or if it was predominantly white or nonwhite. Factors that did play a role included the patient's familiarity with her disease and insurance benefits, prior experience interacting with an insurer, tolerance of risk, and familiarity and ease with the health care system and its jargon. (Click for more...) Use of digital health activity trackers linked to better medication adherence: study 4/20/2019 2:05:01 AM Use of digital health activity trackers linked to better medication adherence: study Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Patients with diabetes and hypertension who use digital health activity trackers are more likely to take their medications as prescribed, according to a recent study by Evidation Health. The study analyzed Humana claims and activity data from 8,500 individuals. Those who tracked activity through wearables and connected apps by Apple, Fitbit, Garmin, and Jawbone were 1.3 times more likely to adhere to their medication regimen for chronic conditions, said the study, which is published in the Journal of Medical Internet Research. Jessie Juusola, PhD, Evidation's senior director of health outcomes research and the study's principal investigator, said: "This signals that everyday behavior data from activity tracking may be a useful tool for identifying individuals who could benefit from medication adherence programs." The researchers found that medication adherence improved as the consistency of tracker use and activity levels increased. (Click for more...) Employee wellness programs yield little benefit, study shows 4/20/2019 2:05:01 AM Employee wellness programs yield little benefit, study shows Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 A new study explored the effectiveness of workplace wellness programs in improving workers' health and reducing overall medical spending. The study, reported in the Journal of the American Medical Association, examined the experience of 33,000 workers at BJ's Wholesale Club, a members-only warehouse retailer, over 1.5 years. Workers who enrolled in the wellness program reported that they learned to exercise more and watch their weight, but the research found no significant differences in outcomes, such as lower blood pressure or sugar levels. There was also no significant reduction in workers' health care costs. "These findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term," wrote the study's authors, Zirui Song, MD, PhD, a health policy researcher at Harvard Medical School, and Katherine Baicker, PhD, dean of the University of Chicago Harris School of Public Policy. However, there were also some encouraging notes among those who adopted healthier behaviors that could eventually lead to better overall health and lower medical expenses, according to Baicker. A recent survey by the Kaiser Family Foundation found that the majority of employers—82% of companies with more than 200 workers—offer some sort of wellness program, such as smoking cessation. Companies typically encourage participation by offering workers financial incentives like gift cards for tracking their steps or even discounts for health insurance costs. (Click for more...) To woo shoppers, stores are accepting competitors' returns 4/20/2019 2:05:01 AM To woo shoppers, stores are accepting competitors' returns Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Walgreens Boots Alliance (WBA) and Nordstrom will allow online shoppers at other retailers pick up or return orders at some stores. Walgreens will start offering package pickup and returns at more than 8,000 U.S. locations to partners such as Levi Strauss and Urban Outfitters. Nordstrom will test doing the same at seven stores in Los Angeles with a group that includes Cole Haan, said the companies. For example, when shoppers want to return a product purchased on Levi.com, they can ship it to Levi, drop it off at a Levi store, or take it to a Walgreens store. "The main thing is this will drive more footfall into Walgreens," using the chain's convenient locations as an asset, said Alex Gourlay, co-chief operating officer of WBA. The Walgreens and Nordstrom arrangement is being brokered by Narvar Inc., a software and technology company that manages order tracking and customer communication around online orders and returns for hundreds of brands. (Click for more...) Arkansas pharmacy board director says 'all of us' are to blame for opioid crisis 4/20/2019 2:05:01 AM Arkansas pharmacy board director says 'all of us' are to blame for opioid crisis Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Arkansas State Board of Pharmacy Executive Director John Kirtley blames "all of us" for the opioid crisis. "If we don't all take our own ownership in what role we play in this, then we can't work together to fix it," Kirtley says. The addiction problem in Arkansas is partially due to over-prescribing. The state, which has about 3 million people, has nearly 115 opioid prescriptions per 100 people. The national average is just 66.5 prescriptions. "When you look at the numbers, it is absolutely astounding," Kirtley says. "These are dangerous drugs. They have very beneficial uses, but they can also be very harmful." Additionally, even though naloxone can help prevent opioid overdoses, the drug can be expensive. (Click for more...) A piece of the pie: Independents build new business models 4/20/2019 2:05:01 AM A piece of the pie: Independents build new business models Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Data released by the National Community Pharmacists Association (NCPA) reveals that approximately 35% of pharmacies nationwide are independent pharmacies, totaling 21,909 in 2017. Tim Hamrick, president and CEO of Bessemer, AL-based American Pharmacy Cooperative Inc., says to remain competitive, independent operators should take steps to buy better from their wholesalers and leverage technology to improve efficiencies and streamline inventories. Kurt Proctor, senior vice president of strategic initiatives and president of the Innovation Center at the NCPA, says PBMs drive more profitable patients to their own networks while shifting more complex cases to other pharmacies. He says many independent pharmacies have found revenue-driving niches or partnerships with local medical facilities that focus on specific illnesses, while others focus on expanding their front-end departments and selecting locations underserved by competitors. Patrick Devereux, pharmacist at FMS Pharmacy in Bessemer, AL, adds: "We need to utilize opportunities to practice at the top of our license, and there are services that we can provide that have higher margins and are higher-impact services than simply dispensing prescriptions." FMS provides health screenings for some large self-insured employer groups in the area. "It is something we can be paid for that delivers value to both patients and employers," Devereux explains. "These are models that are already working in both chain pharmacies and independent pharmacies, and these do not depend on PBMs." (Click for more...) Congress to consider raising tobacco-buying age to 21 4/20/2019 2:05:01 AM Congress to consider raising tobacco-buying age to 21 Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Senate Majority Leader Mitch McConnell (R-KY) said Thursday he will introduce legislation to increase the minimum age to buy tobacco from 18 years to 21. Already, more than 12 states have passed or enacted laws raising the minimum age to 21, and others are considering following suit. McConnell, who said he plans to introduce his bill in May, said he hoped to curb the use of e-cigarettes among youth. "For some time, I've been hearing from the parents who are seeing an unprecedented spike in vaping among their teenage children," the senator said. Statistics show that youth use of e-cigarettes increased 78% from 2017 to 2018, due in large part to the popularity of USB-shaped vaporizers made by Juul. (Click for more...) NIH funds study in four states to reduce opioid related deaths by 40% over 3 years 4/20/2019 2:05:01 AM NIH funds study in four states to reduce opioid related deaths by 40% over 3 years Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 NIH is launching a more than $350 million study that aims to substantially reduce opioid overdose deaths in four states hit hard by the opioid crisis. The study, conducted in partnership with the Substance Abuse and Mental Health Services Administration, has set a goal of lowering overdose deaths by 40% over 3 years in Kentucky, Massachusetts, New York, and Ohio. HHS Secretary Alex Azar explained, "The HEALing Communities Study is an exciting, unprecedented effort to support communities in using and expanding our scientific understanding of effective interventions. It is a major new step in local and national efforts that are beginning to turn the tide on this public health crisis." For the study, grant awards were issued to the University of Kentucky, Lexington; Boston Medical Center, Boston; Columbia University, New York City; and Ohio State University, Columbus. Each site will work with at least 15 communities to assess the effects of integrating evidence-based prevention, treatment, and recovery interventions across primary care, behavioral health, justice and other settings in hard-hit parts of the United States. The HEALing Communities Study will track communities as they reduce the incidence of opioid use disorder (OUD), increase the number of individuals receiving medication-based treatment for OUD, increase treatment retention beyond 6 months, provide recovery support services, and expand the distribution of naloxone. (Click for more...) Torrent expands recall of losartan potassium and losartan potassium/hydrochlorothiazide 4/20/2019 2:05:01 AM Torrent expands recall of losartan potassium and losartan potassium/hydrochlorothiazide Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Torrent Pharmaceuticals announced that it has expanded its voluntary, nationwide recall of losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets to include an additional 36 lots. The recall follows the detection of trace amounts of an impurity, N-Methylnitrosobutyric acid (NMBA), in an active pharmaceutical ingredient made by Hetero Labs Ltd. Torrent is only recalling lots of losartan-containing products that have NMBA above the acceptable daily intake levels released by FDA. The company has received no reports of adverse events related to the issue thus far. Patients who are taking losartan potassium tablets or losartan potassium/hydrochlorothiazide tablets should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is suddenly stopped without any alternative treatment lined up. Patients should talk to their physician or pharmacist about an alternative treatment prior to returning their medication. (Click for more...) Effect of anti-CD4 antibody UB-421 on HIV-1 rebound after treatment interruption 4/20/2019 2:05:01 AM Effect of anti-CD4 antibody UB-421 on HIV-1 rebound after treatment interruption Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Researchers may have found a way to avoid HIV-1 rebound in antiretroviral therapy (ART) patients undergoing analytic treatment interruption. They theorized that UB-421, an antibody that blocks the virus-binding site on human CD4+ T cells, would maintain virologic suppression while avoiding antibody resistance in the absence of ART. In an open-label Phase II trial, investigators worked with 29 patients receiving ART with undetectable plasma viremia, defined as fewer than 20 copies per millilter. After stopping treatment, eight I.V. infusions of UB-421 were administered to each participant. A group of 14 patients received 10 mg per kg of body weight every week, while the other 15 received 25 mg/kg every 2 weeks. The main endpoint was time to viral rebound, established at a threshold of 400 copies per milliliter. UB-421 sustained virologic suppression in all 29 participants over 8–16 weeks of study. Although intermittent viral blips occurred in 8 patients, none of the participants reached the primary outcome measurement. (Click for more...) Lentiviral gene therapy combined with low-dose busulfan in infants with SCID-X1 4/20/2019 2:05:01 AM Lentiviral gene therapy combined with low-dose busulfan in infants with SCID-X1 Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Babies newly diagnosed with X-linked severe combined immunodeficiency (SCID-X1) benefit from reconstituted immunity of T and B cells and normalization of natural killer cells (NK) after lentiviral vector gene therapy plus low-exposure, targeted busulfan conditioning. Except in cases where high-dose chemotherapy is administered, the correction often is needed following allogeneic hematopoietic stem-cell transplantations with no matched sibling donors. Autologous gene therapy with gamma-retroviral vectors previously has been unsuccessful in achieving reconstitution and normalization in this setting, prompting the new approach. With eight infants making up the sample population, researchers used a lentiviral vector to transfer IL2RG complementary DNA to bone marrow stem cells after busulfan conditioning. Acute toxic effects associated with the process were low in grade; and CD3+, CD4+, and naive CD4+ T cells and NK cells normalized within 3 or 4 months post-infusion in seven of the eight babies. The remaining child had an insufficient T-cell count at first, but T cells eventually developed after a boost of gene-corrected cells without busulfan conditioning. During a median 16 months of followup, all previous infections cleared in all infants, who progressed at a normal rate of growth. (Click for more...) Giant Food pharmacy to prescribe fruit and vegetables 4/20/2019 2:05:01 AM Giant Food pharmacy to prescribe fruit and vegetables Thu, 04/18/2019 - 20:00 cbaker_admin Sat, 04/20/2019 - 02:05 Giant Food announced Thursday that one of its stores will participate in a pilot program, Produce Rx, that prescribes fruit and vegetables. Under the program, individuals who receive benefits through the AmeriHealth Caritas DC managed Medicaid health plan can obtain a prescription for produce from a medical professional for a diet-related chronic conditions and fill the prescription in Giant's supermarket pharmacy at 1535 Alabama Ave. SE in Washington, DC. Customers will be able to fill the prescriptions during their shopping trips, receiving a $20 coupon from their Giant pharmacist for buying fresh fruit and vegetables each week. In addition, participating patients will receive nutrition education from AmeriHealth and store tours from Giant's on-site nutritionist. Giant president Gordon Reid said, "As a food retailer, we recognize the important role we can play in the access to healthy foods and health education, and the program is certainly a natural fit with our ongoing efforts to support the health needs of the communities we serve." Giant's Alabama Avenue store represents the only full-service grocery store in Washington, DC's eighth ward. (Click for more...) Federal judge scolds Purdue, Endo and Mallinckrodt for stall tactics in opioids case 4/19/2019 10:00:58 AM Lawyers representing opioid makers filed an emergency motion Wednesday night asking the judge in a multistate case to throw out reports from expert witnesses that estimate the companies would need to pay $480 billion in damages. But the judge was having none of that. (Click for more...) FiercePharmaAsia—Indian generics contenders; Chi-Med's HK listing; Qilu Pharma explosion 4/19/2019 5:44:41 AM A group of Indian generics makers is starting to take the lead in U.S. generics prescriptions; Chi-Med has filed to list on the Hong Kong Stock Exchange; an explosion at a Qilu Pharma subsidiary killed 10 workers and injured 12. (Click for more...) Sub-optimal cholesterol response to initiation of statins and future risk of CVD 4/19/2019 1:05:01 AM Sub-optimal cholesterol response to initiation of statins and future risk of CVD Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Despite widespread use, statins do not benefit every patient with high cholesterol, raising questions about the future risk of cardiovascular disease (CVD) in those with sub-therapeutic response. A team at the University of Nottingham investigated further, using a large cohort study as their medium. The sample population included 165,411 U.K. patients with no evidence of CVD before beginning statin therapy. More than one-half had a suboptimal LDL-C response, defined as a reduction of less than 40% from baseline levels within 24 months of statin initiation. Participants who failed to achieve optimal cholesterol response with statins also were more likely, compared with people who did reach that goal, to experience a CVD event such as coronary artery disease or stroke. They suffered 12,142 such episodes during a median 6.2 years of followup, vs. 10,656 among optimal responders. The researchers believe their results, which offer real-world evidence on the effects of statins, underscore the need for personalized care in lipid management. In particular, they note, validated clinical decision tools capable of predicting cholesterol response to statins or to non-statin drugs, are needed, along with interventions to help clinicians customize and optimize statin treatments for individual patients. (Click for more...) Decision support and alerts of apps for self-management of blood glucose for type 2 diabetes 4/19/2019 1:05:01 AM Decision support and alerts of apps for self-management of blood glucose for type 2 diabetes Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Past research suggests that type 2 diabetics can manage their disease, and even lower their blood glucose levels, with a smartphone app designed for this purpose. A new study evaluated 371 Android and iOS apps that were updated between July 2017 and December 2018, with a critical eye on decision support features and alerts. About 58% of the programs warned users about hypoglycemia or hyperglycemia through an explicit message, color change, or action prompt. In cases of hypoglycemia, patients were advised to consume food, juice, or sugar; remeasure; or seek medical attention. Those experiencing hyperglycemia, meanwhile, were prompted to check ketones, seek medical care, monitor closely, or administer insulin. Only 20.7% of apps delivered these suggested actions after an explicit alert for hypoglycemia, however, and just 15.3% delivered them after an explicit warning about hyperglycemia. Moreover, most apps did not recognize back-to-back low or high blood glucose levels as a reason to step up alerts that could have averted episodes of severe hypoglycemia or hyperglycemia. The study results reflect a lack of real-time decision support and, subsequently, missed opportunities to improve care and outcomes. Quality assurance mechanisms such as certification of apps, along with more patient education, could improve the utility of the technology, the researchers add. (Click for more...) Regular cannabis users require up to 220% higher dosage for sedation in medical procedures 4/19/2019 1:05:01 AM Regular cannabis users require up to 220% higher dosage for sedation in medical procedures Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Regular cannabis users may need more than double the amount of sedation typically required for surgery and other procedures, according to new evidence. The study looked at the medical records of patients in Colorado who had endoscopies after 2012, the year recreational marijuana was sanctioned in the state. Among 250 patients, those with daily or weekly exposure to cannabis required 220% more propofol to optimize sedation for routine procedures such as colonoscopy. When fentanyl or midazolam was administered, researchers noted, cannabis users needed 14% and 20% more volume, respectively, than normal. "Some of the sedative medications have dose-dependent side effects, meaning the higher the dose, the greater likelihood for problems," cautioned lead researcher Mark Twardowski, DO. "That becomes particularly dangerous when suppressed respiratory function is a known side effect." He said the study, published in the Journal of the American Osteopathic Association, represents a small first step in better understanding the metabolic effects of marijuana and identifying better care management options in this setting. Twardowski and colleagues are designing follow-up research on differences in requirements for sedation and anesthesia as well as post-procedure pain management for habitual cannabis users versus non-users. (Click for more...) Express Scripts unit to add specialty pharmacy in Hawaii 4/19/2019 1:05:01 AM Express Scripts unit to add specialty pharmacy in Hawaii Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Accredo, Express Scripts' specialty pharmacy, says that it plans to open a new location in Honolulu for people with chronic health conditions. Set to open this summer, the new pharmacy will offer walk-in consultations, home delivery, an infusion center, and on-site nurses, the company said. Oncology treatments and other therapies will also be provided. AlohaCare, a Hawaii-based nonprofit health plan, has chosen Accredo as its preferred specialty pharmacy for members living in Oahu, Kauai, Molokai, Lanai, Maui, and Hawaii Island. "With its mission to care for people who are underserved with specific health needs, AlohaCare is a leader in putting patients first," said Accredo president Brian Seiz. "Accredo's unique model of care aligns with this mission as we work to ensure those with the most complex health conditions are receiving high-touch, patient-centric care." (Click for more...) Survey: 72% of Americans say there is a need for easy, effective home medication disposal 4/19/2019 1:05:01 AM Survey: 72% of Americans say there is a need for easy, effective home medication disposal Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 The results of a new survey shows that many Americans would like safe and easy-to-use methods to dispose of leftover medications at home. While 80% of respondents said they "always" or "sometimes" dispose of their unused medicines, some of these methods include flushing or pouring the products down the drain. Nearly three-quarters of the respondents (72%) said there is a need for easy and effective disposal options, and 65% described themselves as "very" or "extremely" concerned about leftover drugs at home. The survey, conducted by research firm Brightline Strategies and sponsored by DisposeRx, polled 1,700 adults, 700 of whom had been prescribed an opioid in the past 2 years. "These results demonstrate that many Americans realize there is a leftover prescription problem in this country, but not enough understand the far-reaching repercussions of retaining leftover medications in their medicine cabinet," said William Simpson, president of DisposeRx. "Through our ongoing education efforts, we look to empower more individuals to make their environments safer by giving them a quick, convenient and cost-effective way to eradicate all leftover medications from the home in a timely manner." (Click for more...) Memphis-based national pharmacy provider sold 4/19/2019 1:05:01 AM Memphis-based national pharmacy provider sold Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Private equity capital firm Frazier Healthcare Partners has acquired Memphis-based Comprehensive Pharmacy Solutions (CPS), which employs 2,500 pharmacy professionals and provides pharmacy services at more than 800 hospitals and health care facilities nationwide. Frazier general partner Ben Magnano said, "We see this particular sector as having considerable headroom for growth as hospitals and health systems look for ways to better manage drug costs, solve pharmacy staffing challenges, and improve patient care. CPS is a leader in providing inpatient and outpatient pharmacy management services." As part of the transaction, the former chairman of CPS, Don Nickleson, will serve on the board of directors and as an "observer" of the company. Nickleson anticipates that CPS will be able to expand its services to a "significantly broader client base and further invest into our growing outpatient specialty pharmacy management offering." In 2017, CPS acquired Ohio-based Pharmacy Systems Inc., and the two combined firms controlled about $2 billion in U.S. drug spend at the time, according to CPS. (Click for more...) Pharmacy shutdown changes outlook for Shoppers Food sale 4/19/2019 1:05:01 AM Pharmacy shutdown changes outlook for Shoppers Food sale Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Pharmacy departments inside 30 Shoppers Food locations will be closed. United Natural Foods Inc. (UNFI) acquired Shoppers Food & Pharmacy in 2018. Company CEO Steven Spinner said the company was "well down the path" of selling the chain and hoped to have a deal announced within months. Pharmacy scripts and inventory at 24 stores have been purchased by CVS Health, while Walgreens has purchased the scripts and inventory at the remaining locations, according to UNFI. The company said it has "no immediate plans" to close the stores, which operate in the greater Baltimore-Washington area. The shutdown of pharmacies would indicate UNFI has widened its search for buyers beyond traditional food and pharmacy stores. "Closing pharmacies will affect customer counts, because shoppers will no longer come to the store to drop off prescriptions and shop. That's a big deal," said one industry source. "But it does give the seller more flexibility. They could sell it now to a Kohl's department store, or a Staples, or an Amazon fulfillment center. It could be anybody, or a combination of them." (Click for more...) Tips to proactively manage drug shortages 4/19/2019 1:05:01 AM Tips to proactively manage drug shortages Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Several industry experts recently discussed the various challenges facing hospital pharmacies, including drug shortages. "The drug shortage crisis results in an ongoing absence of a stable supply of essential and frequently critical lifesaving drugs … [and is] one of the critical demands placed on hospital leadership," said Carina Dolan, PharmD, director for clinical oncology and pharmaceutical outcomes at Vizient. Although it can be difficult to control the crisis, hospital pharmacy leaders have found several ways to manage. For example, Marvin Finnefrock, PharmD, divisional president of clinical purchasing services at Comprehensive Pharmacy Services, recommends that before trying to solve more complex issues such as drug shortages, hospital pharmacies ensure that the basics like time management and good hiring practices are met. He also recommends that hospitals and health system pharmacies do not hoard products or purchase them in abundance since it can worsen shortages. Meanwhile, Seth Hartman, PharmD, director of pharmacy informatics at the University of Chicago Medicine, said hospital pharmacies should work with key stakeholders to protect the system from feeling the effects of a drug shortage. Hartman explained that the University of Chicago Medicine has a committee that meets three times a week to mitigate drug shortages. Other suggestions from the experts included using innovative technologies and educating and informing legislators. (Click for more...) Newsom's bid to negotiate lower drug prices gets boost from LA County 4/19/2019 1:05:01 AM Newsom's bid to negotiate lower drug prices gets boost from LA County Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Gov. Gavin Newsom of California said Wednesday that Los Angeles County will join the collective drug-purchasing system that he is developing for state agencies. On the day he took office, Newsom signed an executive order to create a single purchaser of prescription drugs by 2021 for the 13 million individuals covered by Medi-Cal, the state's health care program for the poor, and other agencies that purchase drugs for state employees, retirees, hospitals, and inmates. He urged local governments and private companies to participate in the system, which he said would give them more leverage to negotiate lower prices for medicines. Los Angeles County spends almost $250 million annually on prescriptions just at its public hospitals and clinics. According to Janice Hahn, chair of the county Board of Supervisors, Los Angeles and the state would be "more effective when we work together." Newsom said Wednesday he has discussed his plan with other governors as well. (Click for more...) Georgia governor signs medical marijuana bill 4/19/2019 1:05:01 AM Georgia governor signs medical marijuana bill Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Gov. Brian Kemp of Georgia on Wednesday signed a bill that resolves a legal issue for state residents who wish to buy medical marijuana. The law, which takes effect on July 1, permits the in-state production of a low-potency medical marijuana oil and closes a loophole in a 2015 law that prohibited growing, buying, and selling the drug but allowed some patients to possess it. "Instead of crossing state lines, breaking numerous laws in the process, these families can now stay in our great state," Kemp said. "We are ensuring that these families can purchase what works for their loved ones without creating a slippery slope." Under current state law, individuals with 16 specific conditions—including seizure disorders and Parkinson disease—may possess cannabis oil with less than 5% THC. The law grants up to six growing licenses to private companies and gives pharmacies priority for distributing the drug, although a state commission could look for independent retail locations if it finds there is a need. (Click for more...) CVS fined for filling fake prescriptions 4/19/2019 1:05:01 AM CVS fined for filling fake prescriptions Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 The U.S. Attorney's Office for the District of Rhode Island said CVS Health has agreed to pay $535,000 to settle allegations the company filled forged prescriptions for oxycodone-acetaminophen (Percocet—Endo Pharmaceuticals). CVS locations in Rhode Island filled 39 prescriptions for oxycodone-acetaminophen, a Schedule II opioid analgesic, despite the fact that its pharmacists "had reason to know" they were fraudulent, officials said. The Justice Department reached the settlement following an investigation by the U.S. Attorney's Office and DEA's Office of Diversion Control. Woonsocket, RI-based CVS Health admitted no wrongdoing in connection with the settlement. Michael DeAngelis, CVS Health's senior director of corporate communications, said: "There was no admission of liability or wrongdoing, and we agreed to this settlement to avoid the delay, uncertainty, and expense of litigation." (Click for more...) Appalachian Regional Prescription Opioid Strike Force takedown results in charges against 60 4/19/2019 1:05:01 AM Appalachian Regional Prescription Opioid Strike Force takedown results in charges against 60 Wed, 04/17/2019 - 20:00 cbaker_admin Fri, 04/19/2019 - 01:05 Federal officials announced Wednesday enforcement actions against 60 individuals, including 53 medical professionals, for their alleged participation in the illegal prescribing and distributing of opioids and other dangerous narcotics. The takedown by the Appalachian Regional Prescription Opioid Strike Force—which focuses on Alabama, Kentucky, Ohio, Tennessee, and West Virginia— included charges involving more than 350,000 prescriptions for controlled substances and more than 32 million doses of drugs. HHS also reported that since June 2018, it has excluded more than 2,000 individuals from participation in Medicare, Medicaid, and all other federal health care programs, including some 650 providers who were excluded for conduct related to opioid diversion and abuse. "Opioid misuse and abuse is an insidious epidemic, created in large part, by the over-prescribing of potent opioids nationwide, and unfortunately, Appalachia is at the center," said DEA Assistant Administrator Martin. "Today's announcement sends a clear message that investigations involving diversion of prescription drugs have been, and continue to be, a priority for DEA." Among those charged in today's enforcement actions are 31 doctors, 8 nurse practitioners, 7 pharmacists, and 7 other licensed medical professionals. (Click for more...) Gorsky says military service had 'profound effect' on his reign as J&J chief 4/18/2019 11:32:48 PM What does it take to steer one of pharma’s biggest whales? As Johnson & Johnson CEO Alex Gorsky told Fortune magazine, six years in the U.S. Army made all the difference. (Click for more...) 0.9% Sodium Chloride Large Volume Bags 4/18/2019 8:00:00 PM Drug: 0.9% Sodium Chloride Large Volume Bags, Revision Date: Fri, 19 Apr 2019 (Click for more...) 0.9% Sodium Chloride Small Volume Bags (< 150 mL) 4/18/2019 8:00:00 PM Drug: 0.9% Sodium Chloride Small Volume Bags (< 150 mL), Revision Date: Fri, 19 Apr 2019 (Click for more...) Fluticasone and Salmeterol Powder for Inhalation 4/18/2019 8:00:00 PM Drug: Fluticasone and Salmeterol Powder for Inhalation, Revision Date: Fri, 19 Apr 2019 (Click for more...) Losartan and Hydrochlorothiazide Tablets 4/18/2019 8:00:00 PM Drug: Losartan and Hydrochlorothiazide Tablets, Revision Date: Fri, 19 Apr 2019 (Click for more...) Ondansetron Hydrochloride Injection 4/18/2019 8:00:00 PM Drug: Ondansetron Hydrochloride Injection, Revision Date: Fri, 19 Apr 2019 (Click for more...) Scopolamine Transdermal System 4/18/2019 8:00:00 PM Drug: Scopolamine Transdermal System, Revision Date: Fri, 19 Apr 2019 (Click for more...) Robots, Reactions & Automated Labs 4/18/2019 11:23:47 AM Automation is transforming numerous industries. From factory floors to checkout lines to our own homes, more and more processes are being handled by computerized machines – and research labs are finally starting to embrace this change as well. While some industries have turned to automation just to cut labor costs, scientific research can use it […] (Click for more...) 'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst 4/18/2019 11:08:08 AM What used to be a 12 million prescription advantage the “old guard” generics firms held has been overturned, and the “next six” firms—including a slew of Indian drugmakers—now boast a lead of about 2 million as of the end of March. (Click for more...) Online Exclusive: Some fees have “DIRe” consequences 4/18/2019 10:49:02 AM Online Exclusive: Some fees have “DIRe” consequences Mon, 04/22/2019 - 12:00 tenglish@aphanet.org Thu, 04/18/2019 - 10:49 By David Bunch In the 15-year timespan from 2003 to 2018, one in six rural independent pharmacies had closed their doors for the last time.1 Speculation may point to many potential reasons, but there i...Only allowed members have full access to this content.Log in to view full content. (Click for more...) Roche throws in the towel on Tecentriq bladder, myeloma trials 4/18/2019 10:44:43 AM Roche’s Tecentriq has scored some important victories lately, including a pair of first-in-class approvals. But in other types of cancer, the Swiss drugmaker has decided to pull the plug. (Click for more...) New guide shows how penicillin allergy testing can be done in different settings 4/18/2019 10:35:34 AM New guide shows how penicillin allergy testing can be done in different settings Thu, 04/18/2019 - 10:40 caldridgeyoung… Thu, 04/18/2019 - 10:35 Within the guidance, published in the American Journal of Health-System Pharmacy, the authors discuss criteria for appropriate use at the patient level, along with institutional examples, resource considerations, legal restrictions, and program sustainability. (Click for more...) Time to give up on biosims, experts say. Price regulations would deliver more savings 4/18/2019 10:16:10 AM Biosimilar drugs aren't working to cut drug costs, experts say. Instead, it's time to control prices on biologics after the drugs lose exclusivity. (Click for more...) HIV drugmakers ViiV, Gilead top 2018 pharma reputation survey 4/18/2019 9:43:15 AM Pharma’s reputation is holding steady with patient groups. That’s according to the annual patient opinion report from PatientView, which found that 41% thought the pharma industry reputation's was “excellent” or “good” in 2018, compared to a similar 43% in 2017. (Click for more...) Lonza plagued by supply problems after China plant explosion 4/18/2019 9:40:48 AM An explosion at a chemical plant in China that killed 62 people not only exposed weaknesses in China’s safety oversight but it also exposed weaknesses in the global ingredient supply chain. The disruption from the blast has exacerbated shortages for Swiss pharma and chemical supplier Lonza. (Click for more...) 'Fingerprint database' could help pinpoint environmental cancer causes 4/18/2019 6:11:13 AM Until now, scientists have had only a limited number of tools for working out the cause of an individual’s tumour. (Click for more...) NICE final guidance published for Cimzia 4/18/2019 6:10:11 AM For adults who have failed to respond to, or are unsuitable for, other systemic therapies. (Click for more...) Public ‘unaware’ they have a choice of hospitals for NHS treatment 4/18/2019 6:08:15 AM The legal right to choice has been in place for over a decade, but just 48% of the public are currently aware of it. (Click for more...) PureTech Health, Boehringer Ingelheim enter $26M immuno-oncology deal 4/18/2019 6:07:03 AM PureTech Health will receive up to $26 million under the transaction. (Click for more...) FDA takes steps to protect consumers from unlawful ingredients in dietary supplements 4/18/2019 12:05:01 AM FDA takes steps to protect consumers from unlawful ingredients in dietary supplements Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 As part of its ongoing efforts to protect consumers from potentially unlawful dietary supplements, FDA said Tuesday it is launching a new tool to quickly alert the public to when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements. The Dietary Supplement Ingredient Advisory List will be located on the FDA website, with ingredients added after an initial FDA assessment that indicates they might not lawfully be in supplements. FDA notes that "inclusion of an ingredient on this List is not necessarily an indication of safety concerns. The FDA will continue to communicate separately and clearly any time we identify safety concerns about dietary ingredients or dietary supplements." Consumers can sign up to receive updates and changes to the list. Stakeholders can also submit feedback in support of or against the agency's preliminary assessment about the ingredients. FDA noted it has also warned eight companies for marketing dietary supplements containing DMHA and three companies for products containing phenibut. The companies have 15 business days to inform FDA of the steps they will take to bring their products into compliance with the law. According to FDA Deputy Commissioner for Food Policy and Response Frank Yiannas, "Today's actions are part of the FDA's overall efforts to strengthen the agency's regulation in a manner that strikes the right balance between preserving consumer access to lawful dietary supplements while also protecting Americans from the potential dangers of products that don't meet the agency's standards for dietary supplements." (Click for more...) Opioid users call Kratom a godsend, but FDA says it's a menace 4/18/2019 12:05:01 AM Opioid users call Kratom a godsend, but FDA says it's a menace Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 The steep rise in the number of people suffering opioid addiction has helped spawn the widespread use of kratom, a green powdered herbal supplement that is widely available and virtually unregulated. Several million Americans are now believed to use kratom. Governmental authorities warn that kratom can be dangerous. Reported adverse events include seizures, hallucinations, and symptoms of psychosis, and there have been calls from inside the Trump administration to curb its use. "There is no evidence to indicate that kratom is safe or effective for any medical use," said former FDA Commissioner Scott Gottlieb. The agency has warned people to avoid using kratom, saying it "appears to have properties that expose users to the risks of addiction, abuse, and dependence." It has also raised concerns about false marketing and impurities in the supply. Last week, CDC reported that kratom had been found to be a cause of death by medical examiners or coroners in 91 out of 27,000 overdose deaths reported to the agency over an 18-month period ending in December 2017. However, in almost all of the 91 fatalities, toxicology tests determined that other drugs were present. In seven deaths, kratom was the only substance found, though CDC said that it could not rule out the presence of other substances in those cases. (Click for more...) Doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs. placebo for oral mucositis pain 4/18/2019 12:05:01 AM Doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs. placebo for oral mucositis pain Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 For individuals undergoing radiotherapy for head and neck cancer, oral mucositis is a major adverse effect, affecting more than 80% of patients. Researchers from the Mayo Clinic sought to determine whether doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash compared with placebo reduced pain from oral mucositis in this population. The Phase III study—conducted at 30 U.S. institutions between 2014 and 2016—included 275 patients who underwent definitive head and neck radiotherapy, had an oral mucositis pain score of 4 points or higher, and were followed up for a maximum of 28 days. Participants were randomized to doxepin mouthwash (25 mg/5 mL water), diphenhydramine-lidocaine-antacid, or placebo. In the first 4 hours, mucositis pain dropped by 11.6 points in the doxepin mouthwash group and by 11.7 points in the diphenhydramine-lidocaine-antacid mouthwash group, compared with 8.7 points among the placebo recipients. Compared with placebo recipients, doxepin mouthwash recipients reported more drowsiness, unpleasant taste, and stinging or burning in the first 4 hours after treatment. According to the researchers, for "patients undergoing head and neck radiotherapy, the use of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash compared with placebo significantly reduced oral mucositis pain during the first 4 hours after administration; however, the effect size was less than the minimal clinically important difference." The authors recommend additional study to investigate longer-term efficacy and safety for both products. (Click for more...) Cure for hepatitis B pushed 4/18/2019 12:05:01 AM Cure for hepatitis B pushed Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Researchers convening at the International Liver Conference in Vienna, Austria, noted the challenges of finding a cure for hepatitis B virus (HBV). Massimo Levrero, PhD, a member of the governing body of the International Coalition to Eliminate HBV (ICE-HBV) and director of the Cancer Research Centre of Lyon in France, said: "I think we are still at least 3 years away from starting a Phase III clinical trial that would probably include a combination therapy." Levrero said there are numerous drug treatment candidates being tested to attack various structures of the virus. Hepatitis B has been cured by various methods in less than 10% of cases, says Peter Revill, PhD, senior medical scientist at the Victorian Infectious Diseases Reference Laboratory in Melbourne, Australia. He estimates that up to 1 million people worldwide have been cured of hepatitis B, but there are an estimated 257 million people still living with the infection. Revill added, "Once chronic infection is established, patients are exposed to significant risk of liver disease including chronic hepatitis, cirrhosis, and hepatocellular carcinoma." Researchers at the conference said, "ICE-HBV seeks to achieve its goals by fostering collaborative partnerships with researchers (both within the HBV field and outside), clinicians, the pharmaceutical industry, and a range of stakeholders, including communities affected by chronic hepatitis B." (Click for more...) Pharmacies expanding offerings to attract customers 4/18/2019 12:05:01 AM Pharmacies expanding offerings to attract customers Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Meijer, CVS, and Walgreens are among community pharmacies that are expanding their health care services, offering much more than prescriptions. Pharmacists, nurse practitioners, and technicians are now in stores to help with everything from acne treatment to teeth straightening to eyelash lengthening, along with strep tests, rapid influenza screenings, vaccines, and HIV testing and treatment. "Our intention is to never replace a family physician but we work in conjunction with them," says Jamie Vroman, regional pharmacy specialist for Meijer. "The nice thing about a pharmacy is we have extended hours in the evenings and weekends. Unfortunately, we don't always get sick during business hours Monday through Friday. We are trying to fill a void to help those patients." Meijer has a strict protocol for its pharmacists to follow: Only licensed pharmacists can test for strep and influenza. The services are provided in a private consulting room or, sometimes, the consulting area of the pharmacy. If patients test positive for the strep or influenza, the pharmacist then provides access to necessary medications. The reach is substantial. Michigan has 2,100 pharmacies, a combination of chain and independently owned stores, staffed by some of the state’s 14,000 pharmacists, according to pharmacist Farah Jalloul, director of professional development for the Michigan Pharmacists Association. "A pharmacist is the most accessible individual in health care, the first person you talk to when you get sick, even if it’s in the middle of the night," Jalloul notes. (Click for more...) Rite Aid highlights MMR vaccine availability 4/18/2019 12:05:01 AM Rite Aid highlights MMR vaccine availability Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Amid the growing number of measles cases around the United States, Rite Aid said Tuesday that measles, mumps, and rubella (MMR) vaccines are available upon request at its pharmacies nationwide. "At Rite Aid, all of our pharmacists are certified immunizers that can vaccinate patients against a number of diseases, including measles, based on CDC's vaccine guidelines and state regulations," said Rite Aid vice president of clinical services, Summer Kerley. "Our focus is on providing value-based care that improves the health outcomes of patients and the communities where we operate and offering immunizations is a key component of that focus." No appointment is necessary. The vaccines are available during normal pharmacy business hours, Rite Aid said. As of April 11, CDC had confirmed 555 cases of measles in the United States. (Click for more...) Use of opioid overdose deaths reported in one state's criminal justice, hospital, and prescription databases to identify risk of opioid fatalities 4/18/2019 12:05:01 AM Use of opioid overdose deaths reported in one state's criminal justice, hospital, and prescription databases to identify risk of opioid fatalities Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 As the opioid crisis rages on in the United States, there has been a call to link state-based prescription drug monitoring databases (PDMPs) with other systems in order to flag individuals at high risk for overdose. Researchers from Johns Hopkins Bloomberg School of Public Health, working with the Maryland Department of Health, tested this approach using data from 2015–16. They identified residents who had an opioid prescription entered into the state PDMP, were documented in hospital records after an emergency department visit or admission, or were included in criminal justice reporting because of a property or drug offense. These millions of records were integrated with opioid overdose death records from the medical examiner's office. Most people who suffered a fatal overdose during the 2-year study period, approximately 60%, were previously captured in at least one of the described data sets. About one-third had a background of prescription opioid use, for an opioid overdose rate of 63 per 100,000 individuals; and nearly one-half had hospital records, for a rate of 99 per 100,000 individuals. The risk of overdose was also elevated for those with a criminal justice connection, especially if they were also included in one or more of the other data sets. A presence in multiple data sets of any combination, meanwhile, equated to an overdose rate of 765 per 100,000 individuals. The study showcases linked databases as a promising resource for population overdose surveillance. (Click for more...) AmerisourceBergen supports transitioning pharmaceutical rebates to POS discounts 4/18/2019 12:05:01 AM AmerisourceBergen supports transitioning pharmaceutical rebates to POS discounts Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 AmerisourceBergen, with its industry trade association, the Healthcare Distribution Alliance, recently announced that it has proposed a comprehensive framework that would support the proposed move from the current rebate system to point-of-sale (POS) discounts. The move comes in response to HHS' Notice of Proposed Rule Making regarding the Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals. The transition to a patient-centered model would begin January 1, 2020. "As the connector of pharmaceutical innovators and health care providers, distributors are uniquely positioned to support the seamless and efficient delivery of POS discounts to Medicare beneficiaries," said Steve Collis, AmerisourceBergen chairman, president and CEO. "We come prepared with solutions that are fair, efficient, and transparent, and that’s why we believe we are best positioned to lead this transition." AmerisourceBergen noted that the distributor-facilitated model would allow chargebacks to be processed with full visibility and audibility by all stakeholders. The company added that in 2018 alone, it exchanged more than 300 million chargeback transactions with manufacturers with greater than 99% successfully completed in 3 business days or less. (Click for more...) Inappropriate pain management after surgery is a major cause of the opioid crisis 4/18/2019 12:05:01 AM Inappropriate pain management after surgery is a major cause of the opioid crisis Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 A series of three papers appearing in The Lancet demonstrate how efforts to alleviate postoperative pain have fed the opioid epidemic. Opioids are the go-to standard for improving patient comfort after an operation, and use of opioid analgesics has grown significantly—including for minor procedures. In addition, there has been a trend of overprescribing after surgery. While prolonged use can predispose some patients to long-term abuse themselves, leftover doses can also be diverted and used by people other than the patients for whom the prescriptions were written. The article authors offer suggestions for mitigating these risks, including specialist transitional pain clinics, drug take-back programs or other opioid disposal options for patients, and non-opioid and opioid-sparing pain management alternatives. They also believe further study is needed to address opioid tolerance and opioid-induced hyperalgesia and that clinical guidelines should provide consensus and clarity on postoperative opioid prescribing. "Over the past decade there has been an increasing reliance on strong opioids to treat acute and chronic pain, which has been associated with a rising epidemic of prescription opioid misuse, abuse, and overdose-related deaths," says Prof. Paul Myles of Australia's Monash University, who took the lead on the series. "To reduce the increased risk of opioid misuse for surgery patients, we call for a comprehensive approach to reduce opioid prescriptions, increase use of alternative medications, reduce leftover opioids in the home, and educate patients and clinicians about the risks and benefits of opioids." (Click for more...) New FDA head vows to carry out crackdown on teen e-cigarette use 4/18/2019 12:05:01 AM New FDA head vows to carry out crackdown on teen e-cigarette use Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Acting FDA Commissioner Ned Sharpless said Tuesday that the agency would continue with efforts launched by his predecessor Scott Gottlieb to curb youth tobacco use. "We'll maintain our focus on ending the use of combustible cigarettes among adults, and on preventing kids from ever starting," Sharpless said, adding that FDA will carry out "vital research to ensure we have the data necessary to make informed regulatory decisions on electronic cigarette products, so that we can reverse the growing epidemic of youth use." Gottlieb had said in November that teen vaping rates were an "epidemic" and began a major regulatory crackdown on vaping. When Gottlieb announced his departure from the FDA in March, some observers speculated that the incoming commissioner would roll back some of Gottlieb’s regulatory efforts. However, Sharpless assured his staff that FDA would not tolerate tobacco and e-cigarette marketing or sales to people under 18 years of age. (Click for more...) Sens. Hirono, Booker reintroduce Access to Birth Control Act 4/18/2019 12:05:01 AM Sens. Hirono, Booker reintroduce Access to Birth Control Act Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Sens. Mazie K. Hirono (D-HI), Cory Booker (D-NJ), and others recently reintroduced the Access to Birth Control Act. According to a press release from Hirono's office, the measure would require pharmacies and pharmacists to provide women with birth control and emergency contraceptives without undue delay. "Women's reproductive rights must not be restricted in any manner—whether it is the right to end a pregnancy or the right to access birth control," Hirono said. "Pharmacists should not be able to interject their own personal beliefs to deny women prescribed medication. I will continue to do everything I can to protect women's health and their right to control their bodies." Specifically, the act requires that a pharmacy provide contraceptives or related medication to a customer on request; if the contraceptive or medication is not in stock, the pharmacy must inform the customer and offer to either refer or transfer the prescription to another pharmacy or to order the medication to that pharmacy to be picked up at a later date; and a pharmacy and its employees not intimidate or interfere with a customer's access to contraceptives. Joining Hirono and Booker in sponsoring the act are 15 other senators, including Sens. Patty Murray (D-WA), Sherrod Brown (D-OH), Sheldon Whitehouse (D-RI), Tammy Baldwin (D-WI), Kirsten Gillibrand (D-NY), and Tim Kaine (D-VA). (Click for more...) Industry calls for changes in two REMS guidances 4/18/2019 12:05:01 AM Industry calls for changes in two REMS guidances Tue, 04/16/2019 - 20:00 cbaker_admin Thu, 04/18/2019 - 00:05 Two recent FDA draft guidances on risk evaluation and mitigation strategies (REMS) should be revised, industry groups say. Released for comment in January, the draft guidances discuss a framework for companies to develop an assessment plan for their REMS programs. The Pharmaceutical Research and Manufacturers of America (PhRMA) says the guidance should be prospective and not apply to existing REMS that already have assessments in place to minimize disruption to those programs. PhRMA wrote, "PhRMA believes that if a pre-specified threshold is not met, there should be an opportunity to revise and improve the REMS goals." Similarly, the Biotechnology Innovation Organization (BIO) is calling for FDA to exempt existing REMS from evaluating patient access and burden on the health care system. BIO noted, "In the case of REMS that are required as part of an initial approval, there is no comparator group of patients who had access to the product without REMS. Without that comparator group, it is very difficult to measure the effect of the REMS program on patient access." The Association for Accessible Medicines (AAM) questioned how the guidance would apply to shared REMS systems. AAM wrote, "The recommendations in the guidance are easier to implement in a brand REMS context and will be much more difficult to employ for single, shared system REMS or separate shared REMS that have multiple ANDA participants." (Click for more...) WVU community invited to student magazine launch event 4/18/2019 12:00:00 AM WVU student organization Ed on Campus will be hosting a release party and panel discussion for their spring 2019 edition of Mirage Magazine on Thursday, April 24, at 6 pm in the Media Innovation Center. (Click for more...) Geriatrics Lunchtime Learning April 24, 2019 4/18/2019 12:00:00 AM Jointly provided by the West Virginia Geriatric Society the West Virginia Geriatrics Education (Click for more...) Consumer watchdog petitions FDA for black box warning on Amgen's Prolia 4/17/2019 11:09:46 PM The FDA has warned patients using Amgen’s osteoporosis drug Prolia that stopping treatment could lead to an increased risk of spinal fractures. Now, a consumer watchdog said the warnings haven’t gone far enough. (Click for more...) Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection 4/17/2019 8:00:00 PM Drug: Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) Carbidopa and Levodopa Extended-Release Tablets 4/17/2019 8:00:00 PM Drug: Carbidopa and Levodopa Extended-Release Tablets, Revision Date: Thu, 18 Apr 2019 (Click for more...) Cosyntropin Injection 4/17/2019 8:00:00 PM Drug: Cosyntropin Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) Dicyclomine Injection 4/17/2019 8:00:00 PM Drug: Dicyclomine Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) Furosemide Tablets 4/17/2019 8:00:00 PM Drug: Furosemide Tablets, Revision Date: Thu, 18 Apr 2019 (Click for more...) Levetiracetam Injection 4/17/2019 8:00:00 PM Drug: Levetiracetam Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) Metoprolol Injection 4/17/2019 8:00:00 PM Drug: Metoprolol Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) Trifluoperazine Tablets 4/17/2019 8:00:00 PM Drug: Trifluoperazine Tablets, Revision Date: Thu, 18 Apr 2019 (Click for more...) Valproate Sodium Injection 4/17/2019 8:00:00 PM Drug: Valproate Sodium Injection, Revision Date: Thu, 18 Apr 2019 (Click for more...) United Therapeutics teamed with pumpmaker to block Remodulin generics, Sandoz suit says 4/17/2019 3:15:13 PM Over the years, pharma watchers have seen instances of drugmakers going to lengths to protect big-selling drugs. Now, United Therapeutics faces allegations of illegally blocking Remodulin generics by teaming with a devicemaker. (Click for more...) Machine Learning Is Accelerating the Pace of Drug Development, But Good Data is Key 4/17/2019 12:17:24 PM Machine learning and deep learning, which fall under the umbrella of AI, are hot topics in pharma R&D today—and they are here to stay. “Every day, chemists are working on the design, synthesis, and application of various molecules and formulations,” explains Elsevier’s Matt Clark in R&D. “Finding hidden relationships for classification and discovery work is […] (Click for more...) Thank you, Jardiance: Diabetes drug sales ease Boehringer's patent-loss pain 4/17/2019 10:54:04 AM As sales of its blockbuster asthma and COPD drug Spiriva flagged last year, Boehringer Ingelheim needed a boost from its other products. Turns out diabetes was the key. (Click for more...) FDA warns maker of children's OTC drugs after bacteria found in water system 4/17/2019 10:50:25 AM A maker of over-the-counter products that include medicines for infants and children has been told by the FDA that it must completely remake its water system because it failed to prevent high levels of bacteria in its products. (Click for more...) After tragic Notre Dame fire, Sanofi pledges €10M to fix the cherished cathedral 4/17/2019 10:42:21 AM The world wept for Paris as Notre Dame burned, and donors have wasted no time putting up millions to rebuild. Sanofi, France's biggest drugmaker, joined them Wednesday with a €10 million gift to restore the cathedral at the heart of its home city. (Click for more...) Tickets available for the 20th International Clinical Researcher of the Year gala dinner & awards ceremony 4/17/2019 9:32:39 AM Tickets are available for those wanting to be a part of one of the most important dates in the clinical research calendar – an evening of celebration and recognition for the very best clinical researchers from across the globe (Click for more...) Novartis beefs up its case for Zolgensma gene therapy ahead of FDA decision 4/17/2019 9:31:15 AM Novartis expects the FDA to decide on its spinal muscular atrophy gene therapy next month, but it’s already padding its case with new phase 3 data. And it's data one executive hopes will quell some concerns raised about the therapy. (Click for more...) Feds oppose white-coat kickbacks suit out of 'animus' against whistleblowers: judge 4/17/2019 9:20:40 AM A judge questioned the Justice Department's motives for nixing a whistleblower lawsuit that claims UCB paid kickbacks to boost Cimzia scripts. The case is one of 11 filed by the National Healthcare Analysis Group and, in an unusual move, fought by the feds themselves. (Click for more...) Lithuanian CDMO adding biologics capacity and more than 60 jobs 4/17/2019 9:09:11 AM Biologics continue to be a growth area for pharma, and a Lithuanian contract manufacturer intends to get a bigger piece of the market with an expansion that essentially doubles its output and will add dozens to its workforce. (Click for more...) Integrating Chemistry Data Sources Provides Big Benefits 4/17/2019 9:00:42 AM Integrating Chemistry Data Sources Provides Big Benefits Global pharmaceutical companies and other organizations are increasingly in need of solutions for data management and integration needs. Having fast and convenient access to a range of chemistry resources—from targets mined from the literature to a firm’s own lab data—is a major priority. Important benefits of integrating chemistry […] (Click for more...) Teva CEO Kåre Schultz nabs whopping $33M in first full year at the helm 4/17/2019 7:23:22 AM If you thought Teva had gone big-time with its 2017 pay package for CEO Kåre Schultz, check out his 2018 numbers. The Israeli drugmaker forked over a whopping $32.5 million to its chief exec, nearly doubling the sum he snagged in 2017—and $20 million of that was cold, hard cash. (Click for more...) New data reinforce effectiveness of Novartis’ Zolgensma for SMA 4/17/2019 6:33:59 AM The Phase III STR1VE data showed that 21 patients were alive and event-free as of September 27 last year. (Click for more...) LifeArc licenses discovery programme to Daiichi Sankyo 4/17/2019 5:37:50 AM The deal successfully concludes a research collaboration between LifeArc, Oxford University’s Nuffield Department of Clinical Neurosciences and Daiichi Sankyo. (Click for more...) Trial results show promise for chemo-free future treatment 4/17/2019 5:36:56 AM 95% of those treated in the study were found to have a complete remission rate. (Click for more...) ‘Landmark’ day for Akcea as NICE recommends Tegsedi in rare inherited hATTR 4/17/2019 5:35:21 AM The decision will allow patients in England with the rare, inherited, severely debilitating and fatal disease to access the treatment on the NHS. (Click for more...) Novartis’ wet AMD drug gets FDA filing 4/17/2019 5:33:27 AM The decision is primarily based on Phase III data from the HAWK and HARRIER trials. (Click for more...) Booking beauty: Allergan's new concierge platform Regi finds medical aesthetic and spa treatments 4/16/2019 11:07:33 PM Allergan’s first-ever digital booking platform for aesthetic treatments, Regi, helps consumers find Allergan-branded medical aesthetics like Botox Cosmetic but also facials, waxing and massages. (Click for more...) Maine pursues plan to stock schools with anti-overdose medication 4/16/2019 11:05:01 PM Maine pursues plan to stock schools with anti-overdose medication Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 In Maine, the administration of Gov. Janet Mills is considering requiring all public high schools and middle schools in the state to stock the nasal spray version of naloxone. The administration is also looking to enhance prevention education, according to Gordon Smith, the state's director of opioid response. He says Mills would prefer to see local school districts voluntarily embrace a staff training program; but if necessary, the administration would support legislation to mandate it. There were 418 drug overdose deaths in Maine in 2017, including 354 caused by opioids, according to the Maine Attorney General’s Office. State records on fatal overdoses show that most involve people beyond their high school years. The Kaiser Family Foundation says among the 960 deaths from opioid overdoses in Maine from 2014 to 2017, 76 people, or 8%, were younger than age 25 years. Maine Education Commissioner Pender Makin backs the proposal, saying she has seen how the opioid epidemic affects students and their families. The city of Portland has had naloxone at its three public high schools since the 2017-18 school year, says Tina Veilleux, the school nurse coordinator for Portland Public Schools and the nurse at the Reiche Community School. She backs expanding the overdose antidote to other high schools. (Click for more...) 90 new cases of measles reported in U.S. as outbreak continues record pace 4/16/2019 11:05:01 PM 90 new cases of measles reported in U.S. as outbreak continues record pace Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 The number of confirmed measles cases in the United States increased sharply in the past week, with 90 new cases as of April 11. CDC said Monday there have been 555 cases of the highly infectious disease recorded so far in 2019. According to health officials, outbreaks have been reported in New York, New Jersey, Washington, California, and Michigan. Many of the cases are associated with travelers returning from countries that are also experiencing outbreaks, including Israel and the Philippines. Worldwide, the number of reported measles cases tripled in the first quarter of 2019 compared with the previous year, the World Health Organization (WHO) said Monday. Every region of the world is experiencing outbreaks. "This is a very unforgiving disease," said Saad Omer, a researcher at the Emory Vaccine Center in Atlanta. Measles took the lives of nearly 110,000 individuals around the world in 2017, the WHO said. The increase in measles cases counters the worldwide success in reducing cases by almost 80% from 2000 to 2016. The new outbreaks are due to a number of reasons, according to experts, including enduring poverty that limits access to the vaccine in nations with limited health systems and rumors that vaccines are dangerous, leading parents to opt out of vaccinations for their children. The WHO cautioned that "measles is one of the world's most contagious diseases, with the potential to be extremely severe." (Click for more...) New cancer therapies offer great hope, but there can be surprising complications 4/16/2019 11:05:01 PM New cancer therapies offer great hope, but there can be surprising complications Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Treating cancer patients has become more promising—but also more complicated—as new therapies that have come to market, writes Ravi Parikh, a fellow in hematology/oncology at the University of Pennsylvania. Just last year, he notes, FDA approved 19 cancer-related drugs, many of which improve the odds of remission and survival and reduce the likelihood or severity of adverse effects. However, Parikh adds, as the landscape shifts from generalized treatments to drugs that target specific genes or molecules through different mechanisms, it becomes increasingly difficult for patients and providers to stay on top of the changes. Also, he says that novel oncology therapies sometimes come with unknown and unanticipated adverse effects. Parikh points to access as an additional area of frustration, with newer immunotherapies often initially available only for certain cancers or in certain locations in the country. Most worrisome, he concludes, is the fact that some oncology patients desperately want to try new drugs, even when a traditional chemotherapy is the best course. "Because of the four-decade investment in the War on Cancer, life expectancy is increasing, side effects are fewer, and cancer can sometimes be a chronic disease rather than a death sentence," Parikh writes. "As treatment options expand by the day, it is exciting ... to learn about these new therapies, while also keeping in mind that existing therapies in cancer can serve some patients." (Click for more...) The data are clear: Ebola vaccine shows 'very impressive' performance in outbreak 4/16/2019 11:05:01 PM The data are clear: Ebola vaccine shows 'very impressive' performance in outbreak Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 New data released by the World Health Organization (WHO) indicate that an experimental vaccine being used to help control an Ebola outbreak in the Democratic Republic of the Congo (DRC) is protective 97.5% of the time. Of the more than 90,000 people who were vaccinated, only 71 later developed Ebola. Fifty-six of those individuals developed symptoms fewer than 10 days after being vaccinated, which could suggest the vaccine had not yet had time to fully protect them. Nearly 29,000 health-care and front-line workers were among the roughly 90,000 vaccinated between August 2018 and March 25, 2019, the span covered by the report. None of the people who developed Ebola 10 days or more after being vaccinated died from their illness. The report observed, "Notably, there were nine deaths among 56 cases with onset of symptoms 0 to 9 days after vaccination [who are assumed to be only partially protected by vaccination] and, no deaths among people where the illness onset occurred 10 days or more after they were vaccinated [who are assumed to be protected by vaccination]." A committee advising WHO Director-General Tedros Adhanom Ghebreyesus, MD, has concluded that the epidemic is not a global threat despite being extensive. As of April 11, there were 1,206 cases and 764 deaths, and nearly 98,000 doses of vaccine were administered. The vaccine is being developed by Merck and used in a ring vaccination strategy. (Click for more...) Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease 4/16/2019 11:05:01 PM Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 The SONAR clinical trial, which evaluated atrasentan in type 2 diabetics with chronic kidney disease, took place in 41 countries and analyzed outcomes in more than 2,600 adult participants. Atrasentan has proven to be a viable short-term solution for reducing albuminuria in this population, but researchers were interested in the long-term renal effects of the selective endothelin A receptor antagonist. With this goal in mind, 1,325 patients were randomized to receive atrasentan and 1,323 were assigned to placebo. The primary outcome was a composite of doubling of serum creatinine or end-stage kidney disease, which was documented in 6% of the atrasentan patients at median followup of 2.2 years and in 7.9% of the controls over the same time period. The findings suggest that selective endothelin receptor antagonists may offer some renal protection in patients with type 2 diabetes who have an elevated risk of developing end-stage kidney disease. (Click for more...) Childhood HPV vaccination 'profoundly' cuts cervical disease in young women 4/16/2019 11:05:01 PM Childhood HPV vaccination 'profoundly' cuts cervical disease in young women Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 A study by researchers in Scotland indicates that young women who received human papillomavirus (HPV) vaccines as adolescents had significantly lower rates of cervical intraepithelial neoplasia (CIN), a precursor to cervical cancer. Receiving three doses of the vaccine at the recommended ages of 12–13 years was associated with "a profound reduction of cervical disease 7 years later," reports Tim Palmer from the University of Edinburgh. Palmer's team studied 138,692 women, about one-half of whom had been fully vaccinated against HPV either at ages 12–13 years, or later in their teens. Rates of CIN were low overall among the women, but compared with unvaccinated women, vaccinated women had an 89% lower rate of CIN grade 3 or worse, an 88% lower rate of CIN grade 2 or worse, and a 79% lower rate of CIN grade 1 (0.69% versus 0.15%). Girls who were vaccinated at ages 12–13 years saw a more extensive benefit because the vaccine was 86% effective for them, compared with 51% effective when administered at age 17 years. "The findings are dramatic and document a considerable reduction in high-grade cervical disease over time," Julia Brotherton, medical director at VCS Foundation in East Melbourne, Australia, wrote in an editorial on the study, which was published in BMJ>. (Click for more...) Amgen sets $21,900 annual price for new bone drug 4/16/2019 11:05:01 PM Amgen sets $21,900 annual price for new bone drug Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Amgen on Monday set the U.S. list price for its new romosozumab-aqqg (Evenity) osteoporosis drug at $1,825 a month, or $21,900 for a full 12-month course of injections. FDA last week approved the bone-building drug for postmenopausal women who are at high risk of fracture, but required the label to have a boxed warning, flagging increased risk of heart attack, stroke, and cardiovascular-related death. The drug, part of a new class of drugs known as sclerostin inhibitors, was studied in large clinical trials for 1 year, and FDA said its use should be limited to 1 year. "We priced this product so that it is clearly a better value than existing agents that build bone," said Murdo Gordon, executive vice president of global commercial operations at Amgen. The drug is designed to reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. (Click for more...) Hy-Vee opens Minnesota HealthMarket Rx, pharmacy locations 4/16/2019 11:05:01 PM Hy-Vee opens Minnesota HealthMarket Rx, pharmacy locations Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Following its acquisition of the former Weber & Judd pharmacy locations earlier this year, Hy-Vee reports that it has opened nine Hy-Vee HealthMarket Rx locations and one Hy-Vee pharmacy location in Minnesota. Official grand-opening events are set to take place at each location—in Rochester, Kasson, Pine Island, Plainview, Preston, Spring Valley, St. Charles, Stewartville, and Zumbrota—in the coming weeks. "We are excited to bring Hy-Vee's health-and-wellness offerings to so many new communities and customers in the Rochester area," said Tryce Polley, Hy-Vee's director of HealthMarket Rx locations. "Customers can expect to see many of the same helpful smiles they know, as well as new friendly faces, as we strive to help make their lives easier, healthier and happier." The converted locations offer traditional pharmacy services plus services including text-messaging notifications, free prescription delivery, automated refill ordering, immunization services, and private medication consultations. (Click for more...) Catalent to buy Paragon Bioservices for $1.2 billion 4/16/2019 11:05:01 PM Catalent to buy Paragon Bioservices for $1.2 billion Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Catalent, a contract drug manufacturer, announced Monday plans to buy Paragon Bioservices for $1.2 billion in cash. Paragon, which is backed by private-equity firms Camden Partners and NewSpring Capital, provides supplies for gene-therapy drugmakers, supplying the viral vectors used to deliver gene replacements to their targets. According to Catalent CEO John Chiminski, the deal will help expand the company's gene-therapy manufacturing capabilities. "It's really one of the fastest-growing areas in health care," he said of gene therapy. "You have the opportunity to basically cure people, not just treat a disease." (Click for more...) Pharmacists like e-prescribing safety features but still worry over medication errors, study finds 4/16/2019 11:05:01 PM Pharmacists like e-prescribing safety features but still worry over medication errors, study finds Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Electronic prescribing and medication administration (ePa) systems can improve care coordination and reduce work for health care professionals. A recent report looked at how the technology may affect pharmacists' activities. According to the study, published in BMC Health Services Research, there are benefits to ePa systems, but they can also lead to pharmacists spending less time with patients. Additionally, while pharmacists value ePa systems' safety features, they were concerned about increased medication risks. Time spent on screening inpatient medication was longer, they said, while the amount of time spent on searching for drug charts declined. (Click for more...) Commentary: There's a pain bill that's actually sensitive to patients--let's pass it 4/16/2019 11:05:01 PM Commentary: There's a pain bill that's actually sensitive to patients--let's pass it Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 Steven Anderson, president and CEO of the National Association of Chain Drug Stores (NACDS), calls on lawmakers to pass the John S. McCain Opioid Addiction Prevention Act (S. 724/H.R. 1614), which he says "reflects simultaneous allegiance to patients with chronic or ongoing pain, to patients with acute or temporary pain who may be at risk of addiction and eventual overdose, to children and others who may find excess opioid medications and abuse them, and to those who care for these individuals." The legislation would limit the supply of a patient’s first opioid prescription to 7 days, when that prescription is for acute pain such as that caused by an injury. Anderson notes the bill "does not limit a prescriber's ability to prescribe alternative pain-management therapies. Nor does the bill in any way limit the treatment of chronic, or ongoing, pain, or of pain related to cancer, illness, or end-of-life—an essential point that must be emphasized." In a January NACDS survey, 60% of respondents supported the concept of limiting an initial opioid prescription to 7 days as a way to reduce the likelihood that a patient becomes addicted and to reduce the number of opioids in the public domain. Only 20% opposed it, with others not expressing an opinion. (Click for more...) MACPAC calls for Congress to eliminate the drug rebate cap 4/16/2019 11:05:01 PM MACPAC calls for Congress to eliminate the drug rebate cap Mon, 04/15/2019 - 20:00 cbaker_admin Tue, 04/16/2019 - 23:05 The Medicaid and CHIP Payment and Access Commission (MACPAC) is recommending Congress eliminate the cap on drug rebates paid to state Medicaid programs. MACPAC, the nonpartisan committee that advised Congress on Medicaid, says the savings from higher rebates would allow states to provide the same level of drug coverage at lower costs and continue to exert downward pressure on price increases. The Congressional Budget Office (CBO) estimates that if enacted, the change could save the federal government between $15 billion and $20 billion over 10 years. MACPAC is also calling on Congress allow states to restrict coverage of new drugs or new drug formulations for up to 180 days after they have been approved by FDA. CBO estimates that would result in federal savings of less than $25 million over 10 years. (Click for more...) Gilead's first big TV push for triple combo Biktarvy showcases HIV diversity 4/16/2019 9:14:42 PM Gilead's Biktarvy zoomed to blockbuster status after its approval last February, but it's facing a range of HIV drug rivals—including the brand-new GlaxoSmithKline drug Dovato. Its new campaign to stand out from that crowd features a diverse group of patients urging HIV-positive people to "keep being you." (Click for more...) 23.4% Sodium Chloride Injection 4/16/2019 8:00:00 PM Drug: 23.4% Sodium Chloride Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Benztropine Mesylate Injection 4/16/2019 8:00:00 PM Drug: Benztropine Mesylate Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Bisoprolol Fumarate Tablets 4/16/2019 8:00:00 PM Drug: Bisoprolol Fumarate Tablets, Revision Date: Wed, 17 Apr 2019 (Click for more...) Bupivacaine Injection 4/16/2019 8:00:00 PM Drug: Bupivacaine Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Bupivacaine with Epinephrine Injection 4/16/2019 8:00:00 PM Drug: Bupivacaine with Epinephrine Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Busulfan Injection 4/16/2019 8:00:00 PM Drug: Busulfan Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Dexamethasone Sodium Phosphate Injection 4/16/2019 8:00:00 PM Drug: Dexamethasone Sodium Phosphate Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Hydroxocobalamin Injection 4/16/2019 8:00:00 PM Drug: Hydroxocobalamin Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Mepivacaine Injection 4/16/2019 8:00:00 PM Drug: Mepivacaine Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Ropivacaine Injection 4/16/2019 8:00:00 PM Drug: Ropivacaine Injection, Revision Date: Wed, 17 Apr 2019 (Click for more...) Antimicrobial stewardship essential for hospitalized patients with asthma 4/16/2019 11:47:40 AM Primary Category: Focus on Asthma CareKey point: Adult patients who received antibiotics within 2 days of being hospitalized for an asthma exacerbation had extended hospital stays, higher hospital costs, higher rates of antibiotic-associated diarrhea, and a similar risk of treatment failure compared with those who did not receive antibiotics or received them later in their hospitalization, according to results of an observational study published in JAMA Internal Medicine. Finer points: Although many patients admitted to the hospital for an asthma exacerbation are given antibiotics, current guidelines do not recommend routine use of these agents. A retrospective cohort study involving 19,811 adults who were hospitalized with an asthma exacerbation and received corticosteroids was conducted to assess the use of antibiotics and associated outcomes. Patients were treated at 542 acute care hospitals across the United States, with data collected from the Premier Inpatient Database for those admitted from January 1, 2015, to December 31, 2016. Only patients who received an equivalent dose of at least 20 mg daily of prednisone were included, and they could not have a documented indication for antibiotics (e.g., bronchitis, sinusitis, active infection). Early antibiotic use was defined as use within the first 2 days of admission and continued for a minimum of 2 days. These patients were compared with those who did not receive antibiotics or received them after 2 days (i.e., late use), with late use potentially signaling a marker of patient deterioration. The median age of the patients was 46 years, the majority were women (72.6%), and 44.4% (n = 8,788) received antibiotics during the first 2 days of their hospital stay. Macrolides were the most common class (51.9%), followed by quinolones (34.8%) and third-generation cephalosporins (19.6%). Also, 598 patients received antibiotics in the late/no initiation group. The propensity score–matched analyses showed that those who received antibiotics within the first 2 days had a longer hospital stay (4 d vs. 3 d), higher hospital costs ($4,776 vs. $3,641), and higher rates of antibiotic-associated diarrhea (1.4% vs. 1.1%) compared with those who received them late or not at all. Also, similar rates of treatment failure were seen for the two groups, with treatment failure defined as initiation of mechanical ventilation, transfer to the intensive care unit after hospital day 2, in-hospital mortality, or readmission for asthma within 30 days of discharge. What you need to know: The current observational analysis shows that inappropriate antibiotic use in patients admitted with asthma exacerbations is common and associated with worse outcomes. Current guidelines recommend against this practice, with antibiotics indicated only for those with a documented infection. The authors noted that discontinuation of unnecessary antibiotics is consistent with CDC’s National Strategy for Combating Antibiotic-Resistant Bacteria. They wrote, “Antibiotic treatment in patients with asthma exacerbation is an appropriate practice for deimplementation because it lacks evidence for effectiveness and it may be harmful.” Deimplemenation is the stopping of practices that are not evidence-based. Use of validated biomarkers such as procalcitonin levels was also discussed as a potential strategy to guide antibiotic use. These findings suggest that antibiotic stewardship targeted toward patients admitted with asthma exacerbations is essential to reduce adverse outcomes. What your patients need to know: Inform patients who are hospitalized for an asthma exacerbation that use of antibiotics may not be warranted. Encourage them to discuss the need for antibiotics if they are prescribed to ensure they are being used appropriately. Sources: Stefan MS, et al. Association of antibiotic treatment with outcomes in patients hospitalized for an asthma exacerbation treated with systemic corticosteroids. JAMA Intern Med. 2019;179(3):333–9. Primary Section Advisor: Devra K. DangSecondary Category: Infectious Diseases (Click for more...) VTE prophylaxis for high-risk ambulatory patients with cancer 4/16/2019 11:20:41 AM Primary Category: Focus on Anticoagulation CareKey point: Use of apixaban (Eliquis—Bristol-Myers Squibb, Pfizer) as thromboprophylaxis in intermediate- to high-risk ambulatory patients receiving chemotherapy for various types of cancers reduced the risk of venous thromboembolisms (VTEs) but increased the risk of major bleeding episodes compared with placebo, and use of rivaroxaban (Xarelto—Janssen) in high-risk ambulatory patients with cancer reduced the risk of VTEs or death from a VTE during the intervention period without increasing the risk of major bleeding, according to results from two trials published in the New England Journal of Medicine. Finer points: The benefits of using thromboprophylaxis in ambulatory patients being treated for cancer is unclear, with some guidelines recommending it for select high-risk patients and others stating it should be given only in the context of a clinical trial. Two studies assessed the use of direct oral anticoagulants (DOACs) for ambulatory patients with cancer at intermediate- or high-risk for VTE. The first trial, known as AVERT, assessed the risk of VTEs for ambulatory patients with cancer who were initiating chemotherapy when treated with apixaban 2.5 mg twice daily (n = 291) or placebo (n = 283) over 180 days. Patients were required to have a Khorana score of at least 2, indicating they were at higher risk for a VTE. The most common types of cancers were gynecologic (25.8%), lymphoma (25.3%), and pancreatic (13.6%). The median duration of treatment was 157 days. Results of the primary endpoint, which was a documented VTE over the 180 days, showed that use of apixaban resulted in a significantly lower percentage of VTEs compared with placebo (4.2% vs. 10.2%; hazard ratio [HR] 0.41 [95% CI 0.26–0.65]). However, the risk of major bleeding was significantly higher in the apixaban group (3.5% vs. 1.8%; 2.0, 1.01–3.95). The second trial, known as CASSINI, assessed the effects of rivaroxaban thromboprophylaxis in patients with a solid tumor or lymphoma who were at higher risk for VTE based on their Khorana score and were initiating a new systemic cancer regimen. Adult patients with a Khorana score of at least 2 were randomized to rivaroxaban 10 mg once daily (n = 420) or placebo (n = 421) for 180 days. The most common cancer in each group was pancreatic (32%), and the mean intervention period was 4.3 months. No difference was observed for the primary endpoint, which was a composite of VTE events and death from VTE up to 180 days (6.0% rivaroxaban vs. 8.8% placebo); however, a significant difference in favor of rivaroxaban was observed for the same endpoint assessed during the intervention period (i.e., start of treatment to last dose plus 2 d). Specifically, the rate was 2.6% in the rivaroxaban group compared with 6.4% in the placebo group (0.40, 0.20–0.80). No significant difference was observed for the rates of major bleeding for the two groups (2.0% rivaroxaban vs. 1.0% placebo). What you need to know: The Khorana score is used to identify patients with cancer who may be at higher risk for VTEs. This risk-assessment algorithm includes factors such as type of cancer, pretreatment hematologic factors, and body mass index to quantify risk (with a score ≥2 on a 6-point scale indicating higher risk). The results of the AVERT and CASSINI trials seem to support the use of apixaban or rivaroxaban for thromboprophylaxis in ambulatory patients with cancer who are at higher risk, with a relatively good safety profile. An accompanying editorial noted that although the results of these two trials are compelling, limitations include the underrepresentation of common cancers (e.g., colorectal, prostate, breast) and that the Khorana score does not take into account the chemotherapeutic regimen. The editorial encouraged trials in patients with individual types of cancer to truly determine the benefit of DOACs for specific populations. What your patients need to know: Inform ambulatory patients with cancer that two recent studies support the use of DOACs for VTE prevention in higher-risk patients. Encourage them to talk to their prescriber to determine if VTE prophylaxis is appropriate based on disease-, drug-, and patient-specific factors. Sources: Carrier M, et al. Apixaban to prevent venous thromboembolism in patients with cancer. N Engl J Med. 2019;380(8):711–9. Khorana AA, et al. Rivaroxaban for thromboprophylaxis in high-risk ambulatory patients with cancer. N Engl J Med. 2019;380(8):720–8. Agnelli G, et al. Direct oral anticoagulants for thromboprophylaxis in ambulatory patients with cancer. N Engl J Med. 2019;380(8):781–3. Primary Section Advisor: Sarah RaySecondary Category: Oncology (Click for more...) Struggling Insys swaps CEOs as Subsys marketing crackdown continues 4/16/2019 11:03:05 AM Insys has weathered years of litigation, investigations and allegations of illegal sales practices to pump up powerful painkiller Subsys. Now, hoping to revamp its business and its rep, the company has brought in a new CEO. (Click for more...) Less than 3 weeks left until the Clinical Researcher of the Year – The Americas gala dinner & awards ceremony 4/16/2019 7:53:55 AM The PharmaTimes Clinical Researcher of the Year – The Americas gala dinner & awards ceremony will be taking place at the Sheraton Hotel in Boston on 4th May. (Click for more...) Genomics England completes first phase of liquid biopsy study 4/16/2019 7:02:22 AM The results will enable researchers to perform an objective technology evaluation of the various market offerings in liquid biopsy in the second stage. (Click for more...) AI could identify existing drugs to help treat eye disease 4/16/2019 7:01:17 AM The research identified seven existing drugs - either already in development or being used to treat other conditions. (Click for more...) Enesi and BARDA to co-develop flu vaccines 4/16/2019 7:00:20 AM The public-private partnership aims to provide a cost-effective technological innovation. (Click for more...) New digital tool helps relieve pressure on NHS 4/16/2019 6:59:06 AM Over 6,250 care homes have already signed up to the system, which is accessible on any device. (Click for more...) Working together to get the best out of AI for all 4/16/2019 6:30:55 AM Despite all the excitement, AI is still talked about in fairly vague terms – with few people able to pin the term down with precision. New research from my Elsevier colleagues examined this phenomenon. (Click for more...) Student pharmacists visiting from Oman share WV experience 4/16/2019 12:00:00 AM Four student pharmacists from Oman: Rohan, Pasent, Gehad and Dalia wrapped up their rotations at the WVU School of Pharmacy last week. Before they left to go home, they shared with faculty and staff what they had learned about pharmacy in the US. Along with their learning experience, they had the opportunity to indulge in some West Virginia culture. Check out part of a video they made during their trip. Link here: https://youtu.be/37swvBMtyi4 (Click for more...) SoP Scholarship and Awards ceremony 4/16/2019 12:00:00 AM The School held its annual Scholarship and Award ceremony last Friday in the Okey Patteson Auditorium. Students, donors faculty and guests gathered in the Pylons for a reception prior to the ceremony. One hundred twenty-seven students earned scholarships and awards this year totaling $162,800. (Click for more...) Hidden Codes for Academic Success 4/16/2019 12:00:00 AM The WVCTSI Females Advancing Clinical and Translational Science (FACTS) group is hosting a special speaker to present a discussion and workshop on academic success. Jeanette South-Paul, M.D., Andrew W. Mathieson UPMC Professor and chair of family medicine at the University of Pittsburgh School of Medicine, will present, "Hidden Codes for Academic Success." This session will begin with a keynote address from 12 to 1 p.m., followed by a workshop from 1:30 to 2:50 p.m. (Click for more...) Fentanyl deaths up 122 percent in West Virginia, say WVU researchers 4/16/2019 12:00:00 AM If heroin is coffee, fentanyl is espresso. Just as a minuscule cup of espresso can hype you up more than a whole mug of coffee, a single exposure to fentanyl can get a user vastly higher than injecting the same volume of heroin. In fact, the Centers for Disease Control and Prevention says fentanyl is 50 times stronger than heroin. (Click for more...) CVS Health touts Caremark's effect on costs, adherence 4/15/2019 10:05:01 PM CVS Health touts Caremark's effect on costs, adherence Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 CVS Health reported that CVS Caremark's 2018 achievements include alleviating the effect of drug price inflation, with a -4.2% price growth for non-specialty drugs and a 1.7% price growth for specialty drugs. Additionally, 44% of CVS Caremark's commercial PBM clients saw their net prescription drug prices decline from 2017 to 2018. "Over the last 3 years, even as drug prices have increased by 25%, CVS Caremark has helped our clients save more than $141 billion by blunting drug price inflation, prioritizing the use of effective, lower-cost drugs, and reducing the member's out-of-pocket spend," said CVS Caremark president Derica Rice. "Moreover, our focused adherence efforts have helped more members take their drugs as prescribed, which we estimate has saved our clients an additional $18.3 billion in avoided medical costs since 2016." Companies that adopted managed formularies, which CVS Caremark uses to promote the use of lower-cost drugs, saw savings of nearly 14% per 30-day prescription in 2018, even as drug price inflation grew four times faster than overall inflation, according to the company. Formulary management strategies also helped keep insulin costs affordable. Additionally, although manufacturer-driven price inflation for specialty drugs measured 7.6% in 2018, CVS Caremark was able to keep specialty drug price growth at just 1.7% for clients. (Click for more...) FDA pulls up Walmart, Kroger, others for selling tobacco to minors 4/15/2019 10:05:01 PM FDA pulls up Walmart, Kroger, others for selling tobacco to minors Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 FDA on Friday reported it has sent letters to Walmart, Kroger, and 10 other convenience store chains for selling tobacco products to minors. The agency asked the companies to submit a plan of action within 30 days, describing how they will address and mitigate illegal sales to minors. "We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids. Retailers in particular are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence," FDA said in the letter. The agency has rolled out a Youth Tobacco Prevention Plan as part of its push to discourage teens from smoking. The new letters "are part of FDA's continued actions as part of its Youth Tobacco Prevention Plan and the agency's ongoing commitment to combat youth access to all tobacco products, including e-cigarettes," said FDA spokesperson Jennifer Rodriguez. (Click for more...) New Jersey law allows terminally ill to get life-ending medications 4/15/2019 10:05:01 PM New Jersey law allows terminally ill to get life-ending medications Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 Gov. Phil Murphy of New Jersey on Friday signed legislation that allows terminally ill patients to end their lives. Under the law, which goes into effect in August, only patients who are irreversibly terminally ill and have a prognosis of 6 months or less to live could acquire medication to end their lives. The law requires that two doctors sign off on the request, that the patient be deemed an adult resident of New Jersey, who can make such a decision and who voluntarily expresses a wish to die. It requires patients to request the medication twice and says they must be given a chance to rescind the decision. At least one of the requests must be in writing and signed by two witnesses. At least one witness cannot be a relative, entitled to any portion of the person's estate, the owner of the health care facility where the patient is getting treatment or a worker there, or be the patient's doctor. Under the law, patients must administer the drug to themselves, and attending physicians would be required to offer other treatment options, including palliative care. California, Oregon, Colorado, Hawaii, Vermont, Washington, and the District of Columbia all have similar laws. (Click for more...) Oregon lawmakers want to make cold meds available without a prescription 4/15/2019 10:05:01 PM Oregon lawmakers want to make cold meds available without a prescription Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 A measure proposed by lawmakers in Oregon would allow consumers in the state to once again purchase cold medicines containing pseudoephedrine without a prescription. House Bill 2303 would not give those drugs the same status as other OTC products, such as aspirin or acetaminophen, because pharmacies would need to keep products containing pseudoephedrine locked. People aged 18 years or older would be able to buy them without a prescription but would need to show a government-issued photo ID. Backers of the bill say requiring a prescription penalizes consumers who rely on the medications to combat allergy symptoms. But Woodburn Police Chief Jim Ferraris says the existing prescription requirement has been effective in combating the meth epidemic in the state. If the proposed bill becomes law, it would be effective only until December 31, 2023. Lawmakers could potentially remove the sunset clause if they think the new regulations are still effective in preventing the use of pseudoephedrine to produce meth. (Click for more...) THC nasal sprays denied by Ohio Board of Pharmacy 4/15/2019 10:05:01 PM THC nasal sprays denied by Ohio Board of Pharmacy Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 At a recent meeting of the Ohio Board of Pharmacy, the group declined to add tetrahydrocannabinol (THC) nasal sprays to the Ohio Medical Marijuana Control Program. Board of Pharmacy lawyer Erin Reed told the Medical Marijuana Advisory Committee that the decision was made following an independent review, public comment period, and efforts to reach out to industry experts. Reed said the Board of Pharmacy had concerns over the effects that alcohol-based sprays could have on the body, and received no responses from industry members in other states that already make intranasal THC products. Reed added that the Board of Pharmacy could re-consider another petition, if one is created, in 6 months. While the Farm Bill passed by Congress in December created a process for states to draw up their own hemp programs, it does not overrule previously established state laws. The Ohio Board of Pharmacy only allows cannabidiol (CBD) products to be legally sold in the state's dispensaries. Reed told the committee she was unaware of any CBD-only products currently being sold. Meanwhile, lawmakers in the state are considering Senate Bill 57, which would create Ohio's hemp program and place it under the Department of Agriculture. Ohio's 43 dispensaries now have a provisional license to build their dispensary locations, but they have not yet received a Certificate of Operation, which would enable them to open for patients to purchase medical marijuana. (Click for more...) FDA approves first targeted therapy for metastatic bladder cancer 4/15/2019 10:05:01 PM FDA approves first targeted therapy for metastatic bladder cancer Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 FDA on Friday granted accelerated approval to erdafitinib (Balversa—Janssen Pharmaceutical) for the treatment of adults with locally advanced or metastatic bladder cancer that has an FGFR3 or FGFR2 genetic alteration and that has progressed during or following prior platinum-containing chemotherapy. According to FDA, patients should be selected for treatment with erdafitinib using an FDA-approved companion diagnostic tool. "Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer," said Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs." A clinical trial involving 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, showed that the overall response rate in patients taking erdafitinib was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for about 5.5 months, on average. Commonly reported adverse events reported by patients taking the drug include increased phosphate level, mouth sores, feeling tired, change in kidney function, diarrhea, dry mouth, nails separating from the bed or poor formation of the nail, change in liver function, low sodium levels, decreased appetite, change in sense of taste, anemia, dry skin, dry eyes, and hair loss. Erdafitinib may cause serious eye problems, and patients should have eye exams intermittently and should report any visual changes immediately. The drug received accelerate approval, and further clinical trials are required to confirm erdafitinib's clinical benefit. FDA also approved the therascreen FGFR RGQ RT-PCR Kit (Qiagen) for use as a companion diagnostic with erdafitinib for this therapeutic indication. (Click for more...) Canagliflozin and renal outcomes in type 2 diabetes and nephropathy 4/15/2019 10:05:01 PM Canagliflozin and renal outcomes in type 2 diabetes and nephropathy Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 For individuals with type 2 diabetes and albuminuric chronic kidney disease, those who took canagliflozin had a lower risk of kidney failure and cardiovascular events, compared with placebo, after a median followup of 2.62 years. The double-blind, randomized CREDENCE trial ended early following a planned interim analysis on the recommendation of the data and safety monitoring committee. Approximately 4,400 patients had undergone randomization by that point. According to the data, the relative risk of the primary outcome—a composite of end-stage kidney disease, a doubling of the serum creatinine level, or death from renal or cardiovascular causes—was 30% lower among the canagliflozin recipients compared with the placebo group, with event rates of 43.2 and 61.2 per 1,000 patient–years, respectively. Additionally, the relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34%, while the relative risk of end-stage kidney disease was lower by 32%. There was also a lower risk of the composite of cardiovascular death, myocardial infarction, or stroke, and hospitalization for heart failure among the canagliflozin recipients. "These results indicate that canagliflozin may be an effective treatment option for renal and cardiovascular protection in patients with type 2 diabetes with chronic kidney disease," the researchers conclude. (Click for more...) The struggle to fight measles in close-knit communities 4/15/2019 10:05:01 PM The struggle to fight measles in close-knit communities Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 Insular and close-knit religious or cultural groups have seen some of the worst measles outbreaks in the United States in recent years. Approximately 75% of measles outbreaks over the past 5 years—defined as three or more linked cases—took place in such tightknit communities, says Nancy Messonnier, MD, acting director of CDC's Center for Preparedness and Response. Such groups share the same culture and are often somewhat isolated from the larger community. The outbreaks have been in communities where there is "distinctly lower vaccination coverage" and "they have lots of interactions with each other," says Messonnier. This year there have been 465 reported measles cases in 19 states. Measles—among the most contagious diseases—has been eliminated in the United States since 2000. So the disease is introduced from someone traveling outside the country or visiting from another country. "In each of these communities the reasons behind under vaccination are different but in every one of them it’s a mixture of a lack of understanding of the risk of measles and concerns about the safety or effectiveness of vaccines," says Messonnier. (Click for more...) One-third of cancer patients use complementary and alternative medicine 4/15/2019 10:05:01 PM One-third of cancer patients use complementary and alternative medicine Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 About one-third of cancer patients turn to complementary and alternative treatments to manage their diagnosis, according to an analysis of CDC survey data, but roughly 29% fail to inform their providers. Physicians are generally supportive of meditation and yoga as pathways that can help patients deal with the stresses of chemotherapy, radiation, and surgery, according to the UT Southwestern Medical Center research. However, study author Nina Sanford, MD, says use of herbal supplements—the No. 1 alternative therapy preferred by cancer patients—creates significant concern. While many survey respondents admitted that they did not realize that they should have informed their provider about alternative medicine use or said their provider never inquired, herbal products can actually undermine conventional cancer treatments. "Some of these supplements are kind of a mishmash of different things," she says. "Unless we know what's in them, I would recommend patients avoid using them during radiation because there's likely not data on certain supplements, which could interfere with treatment. With radiation specifically, there is concern that very high levels of antioxidants could make radiation less effective." The findings appear in JAMA Oncology. (Click for more...) Perioperative FLOT for locally advanced, resectable gastric or gastro-esophageal junction adenocarcinoma 4/15/2019 10:05:01 PM Perioperative FLOT for locally advanced, resectable gastric or gastro-esophageal junction adenocarcinoma Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 More than 700 patients with locally advanced, resectable gastric or gastro-esophageal junction adenocarcinoma took part in a multisite German study to test a new therapeutic option. After randomization, 356 patients were allocated to four preoperative and four postoperative 2-week cycles of fluorouracil plus leucovorin, oxaliplatin and docetaxel (FLOT). For these individuals, fluorouracil was administered as a 24-hour I.V. infusion on day 1. The study's control group, meanwhile, consisted of 360 patients who underwent three preoperative and three postoperative 3-week cycles of epirubicin and cisplatin, both administered on day 1. They also received either continuous I.V. infusion of fluorouracil or oral capecitabine for days 1–21. The primary outcome of overall survival was measured at a median 50 months for the intervention group and 35 months for the controls, with similar safety profiles. The results indicate that perioperative FLOT is superior to epirubicin and cisplastin plus fluorouracil or capecitabine in the setting of gastric and gastro-esophageal junction adenocarcinoma. (Click for more...) Oncology pharmacists linked to substantial cost avoidance 4/15/2019 10:05:01 PM Oncology pharmacists linked to substantial cost avoidance Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 At the 2019 annual meeting of the Hematology/Oncology Pharmacy Association, researchers presented the results of a prospective, observational study which found that a full-time oncology pharmacist improves patient care and cost savings. The study noted that when clinical pharmacists verified oral chemotherapy prescriptions at a single institution, total cost avoidance of $40,000 was achieved over a 3-month period. Furthermore, internal specialty pharmacy capture increased from 31% to 51% during that same time. Beth Gustafson, PharmD, a clinical pharmacist at Saint Luke's Health System in Kansas City, MO, noted that the rising number of oral treatment options for patients with cancer has introduced a new level of patient autonomy and additional complexity to the health care system. These oral oncolytic treatments can be toxic, require multiple supportive care medications, and have significant drug–drug interactions, Gustafson said. To reduce oral chemotherapy prescription errors and improve patient monitoring and drug interaction screening, oncology pharmacists at Saint Luke's Health System began reviewing orders for selected high-risk oral oncolytics before they were transmitted to specialty pharmacies. Of 162 prescriptions reviewed by the investigators August to November 2018, 115 required additional intervention. (Click for more...) New FIP report aims to inspire innovation around non-communicable diseases 4/15/2019 10:05:01 PM New FIP report aims to inspire innovation around non-communicable diseases Sun, 04/14/2019 - 20:00 cbaker_admin Mon, 04/15/2019 - 22:05 A new report from the International Pharmaceutical Federation (FIP) highlights the role of pharmacists in the prevention, early detection, and management of non-communicable diseases (NCDs). The report discusses initiatives in 15 countries, including the United States, that should encourage pharmacists to take a more active part in combating NCDs. The study found that pharmacists' regular interactions with patients can be used to increase prevention of NCDs, responsible use of medicines, and adherence to medication, leading to improved health outcomes. "NCD management is demanding new answers and requiring innovative and creative solutions, many of which could be provided by pharmacists," said Isabel Jacinto, chair of the FIP working group that produced the report. In some countries, however, a lack of access to pharmacists due to workforce shortages is threatening the health of patients with NCDs. The report urges governments to take action to increase the supply of well-qualified pharmacists. Additionally, the working group said that pharmacists' contribution to NCD prevention and management should be recognized and adequately remunerated by public and private third-party payers. "This report sets out the global evidence to advocate, nationally and internationally, for an expanded role for pharmacists in NCD management. It also contains recommended actions for national and local associations of pharmacists," Jacinto said. (Click for more...) Reteplase Injection 4/15/2019 8:00:00 PM Drug: Reteplase Injection, Revision Date: Tue, 16 Apr 2019 (Click for more...) Vitamin D supplements not VITAL to cancer prevention and heart health 4/15/2019 1:48:50 PM Vitamin D supplements not VITAL to cancer prevention and heart health Mon, 04/15/2019 - 14:00 caldridgeyoung… Mon, 04/15/2019 - 13:48 While the hormone’s importance in calcium absorption and bone health has long been established, its benefits in other areas remain hazy and unsupported by clinical evidence. Nevertheless, the hormone’s popularity persists, even permeating health care practices. In 2016, physicians ordered more than 10 million lab tests for vitamin D deficiency for Medicare patients, costing taxpayers $365 million. (Click for more...) Meditation at the Pylons on Apr. 18 4/15/2019 12:00:00 AM Through collaboration with WellWVU and Collegiate Recovery, Wellness of WVU Medicine will host "Meditation at the Pylons" on Thursday, April 18 at 11:15 a.m. (Click for more...) Hyoscyamine Sulfate Injection 4/14/2019 8:00:00 PM Drug: Hyoscyamine Sulfate Injection, Revision Date: Mon, 15 Apr 2019 (Click for more...) Letermovir Injection 4/14/2019 8:00:00 PM Drug: Letermovir Injection, Revision Date: Mon, 15 Apr 2019 (Click for more...) Yellow Fever Vaccine 4/14/2019 8:00:00 PM Drug: Yellow Fever Vaccine, Revision Date: Mon, 15 Apr 2019 (Click for more...) Beacon Discovery Leverages Partnerships and Elsevier Solutions to Further GCPR R&D Related Research 4/13/2019 11:32:08 AM Beacon’s beginnings and The Hive Since its founding in 2016, the trajectory of San Diego startup Beacon Discovery has been linked to Elsevier’s The Hive. A privately held drug discovery incubator that aims to identify and develop molecules targeting G-protein coupled receptors (GCPRs), Beacon Discovery was one of just six companies selected out of more […] (Click for more...) Incidence of type 2 diabetes in men receiving steroid 5alpha-reductase inhibitors 4/12/2019 7:05:01 PM Incidence of type 2 diabetes in men receiving steroid 5alpha-reductase inhibitors Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 With new evidence suggesting that steroid 5alpha-reductase inhibitors elevate the risk for type 2 diabetes, researchers in Taiwan and the United Kingdom scoured national health records for more proof. Specifically, they studied outcomes in men who took steroid dutasteride or finasteride to treat their benign prostatic hyperplasia, comparing them with those of men who took the a blocker tamsulosin. The first leg of the investigation centered around tens of thousands of men in the UK Clinical Practice Research Datalink (CPRD), the study's "discovery" cohort, from 2003–14. Over a mean 5.2 years, the incidence rate for new diagnoses of type 2 diabetes was 76.2 events per 10,000 person-years for dutasteride, 76.6 events for finasteride, and 60.3 events for tamsulosin. The finding—that 5alpha-reductase blockers modestly inflate the risk of type 2 diabetes compared with the alpha blocker tamsulosin—was consistent in a "recovery cohort" culled from the Taiwanese National Health Insurance Research Database (NHIRD) from 2002–12. There was no significant difference in risk, however, between dutasteride and finasteride users. According to the investigators, the results point to a potential monitoring need for men initiating 5alpha-reductase inhibitor therapy, especially if they have other risk factors for type 2 diabetes. (Click for more...) Rite Aid reports mixed results for Q4 4/12/2019 7:05:01 PM Rite Aid reports mixed results for Q4 Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 Rite Aid on Thursday reported net loss from continuing operations for the fourth quarter of $255.6 million, or 24 cents per share, adjusted net loss from continuing operations of $13.3 million, or 1 cent per share, results that fell below Wall Street’s expectations. "In the fourth quarter, we continued generating critical momentum in key areas of our business while taking important steps to position Rite Aid for future growth," said chief executive officer John Standley. "Despite a mild flu season, we delivered our third consecutive quarter of same-store pharmacy sales and prescription count growth, thanks to a record number of immunizations and other script growth initiatives. We also increased Medicare Part D membership within our EnvisionRxOptions PBM," he added. Revenues from continuing operations for the fourth quarter were $5.38 billion compared with revenues from continuing operations of $5.39 billion in the prior year's fourth quarter. Community pharmacy segment revenues were $3.97 billion, flat compared with the prior-year period. Revenues in pharmacy services were $1.46 billion, an increase of 1.2% compared with the prior-year period, which was due to an increase in Medicare Part D membership. Same-store sales from community pharmacy continuing operations for the fourth quarter increased 0.7% over the prior year, consisting of a 2.1% increase in pharmacy sales and a 1.9% decrease in front-end sales. (Click for more...) Opioid sales reps swarmed New York at height of crisis 4/12/2019 7:05:01 PM Opioid sales reps swarmed New York at height of crisis Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 Purdue Pharma's sales force swept through New York State, visiting doctors, and pharmacies nearly half a million times between 2006 and 2017 to promote oxycodone (OxyContin) and other opioid analgesics. The company's sales strategy was among the new disclosures contained in court papers filed on Thursday by Attorney General Letitia James of New York as part of the office's lawsuit against opioid manufacturers, distributors, and eight members of the Sackler family, who control Purdue. During that time the sales force had the most visits per capita, 11,881 per 100,000 people, to rural Herkimer County in the Mohawk Valley, according to the papers. State data shows that the county's rate of emergency room visits involving opioids was nearly three times higher than New York City's in 2017. In a statement, Purdue Pharma said the new court filing "contains factual errors and gross distortions and misrepresentations based on highly selective excerpting of language from tens of millions of documents. The complaint is designed to publicly vilify Purdue and its former directors." (Click for more...) Walgreens, VillageMD partner on Houston primary care clinics 4/12/2019 7:05:01 PM Walgreens, VillageMD partner on Houston primary care clinics Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 In a new partnership, Walgreens and primary care provider VillageMD will work to improve access to primary care in Houston. VillageMD will operate primary care clinics, called Village Medical at Walgreens, next to five Walgreens locations in Houston. The first such location is set to open by year-end. The clinics will provide primary care services for adults that will be integrated with pharmacists, nurses, and social workers, and they will use VillageMD's docOS system. "This collaboration with VillageMD demonstrates our ongoing commitment to create neighborhood health destinations that bring affordable health care services to customers and provide a differentiated patient experience to the communities we serve," said Pat Carroll, Walgreens chief medical officer and group vice president of health care services and clinical programs. "VillageMD has a strong track record nationally of improving outcomes and reducing the cost of health care through their transformative primary care model." (Click for more...) Hawaii primary care network opens in-house pharmacy 4/12/2019 7:05:01 PM Hawaii primary care network opens in-house pharmacy Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 The Bay Clinic, which has eight locations on the Big Island in Hawaii, has unveiled a new in-house pharmacy at its Keaau Family Health and Dental Center. The pharmacy is operated under the 340B drug discount program, which requires drug companies to offer medications at discounted prices through providers that serve vulnerable patient populations. Only Bay Clinic patients can fill prescriptions at the new pharmacy. Patients can order medications from the new pharmacy and have them delivered to any of the clinic's locations. Delivery typically should take a day. Bay Clinic patients can fill prescriptions at Walgreens pharmacies at the same discount, but the new Keaau pharmacy will help increase access to medications. (Click for more...) FDA issues final rule on safety and effectiveness of consumer hand sanitizers 4/12/2019 7:05:01 PM FDA issues final rule on safety and effectiveness of consumer hand sanitizers Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 FDA issued on Thursday a final rule that prohibits the use of certain active ingredients in OTC hand sanitizers. Additionally, the rule aims to ensure that FDA's safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date, and properly reflect current scientific knowledge and increasing use patterns. "Our action today aims to help provide consumers with confidence that the OTC hand sanitizers they're using are safe and effective when they don't have access to water to wash with soap," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. "In today's final regulation we finalized the FDA's previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. We've also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers." According to FDA, less than 3% of the consumer hand sanitizer market will be affected by the final rule, as most currently marketed OTC hand sanitizers user ethyl alcohol as their active ingredient. (Click for more...) Pharmacy group praises Colorado e-prescribing law 4/12/2019 7:05:01 PM Pharmacy group praises Colorado e-prescribing law Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 The National Association of Chain Drug Stores (NACDS) on Monday praised Colorado's enactment into law of an electronic prescribing bill that would require prescriptions for controlled substance prescriptions for Schedules II-IV to be submitted electronically, which will help in the fight against opioid abuse. Gov. Jared Polis of Colorado signed the bill into law, which will become effective January 1, 2021. "With the enactment of this legislation, Colorado has taken significant action to help curb the opioid abuse crisis," said NACDS president and CEO Steven Anderson. "Seventeen states have enacted e-prescribing legislation, which helps to increase security and curb waste, fraud and abuse. NACDS appreciates this important achievement in Colorado toward an even more comprehensive approach to the solution." (Click for more...) Three drug companies to pay $122.6 million to resolve kickback allegations 4/12/2019 7:05:01 PM Three drug companies to pay $122.6 million to resolve kickback allegations Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 The Justice Department reports that Jazz Pharmaceuticals, Lundbeck LLC, and Alexion Pharmaceuticals Inc. will pay a total of $122.6 million to resolve allegations they paid drug copays for their pharmaceuticals through copay-assistance foundations. According to the Justice Department, the pharmaceutical companies violated the False Claims Act by illegally paying copays required by two federal health programs—Medicare and the Civilian Health and Medical Program—for the companies' own products through allegedly independent foundations that the companies used as conduits. Lundbeck agreed to pay $52.6 million to resolve the allegations, while Alexion agreed to pay about $13 million, and Jazz said it will pay the U.S. government $57 million, plus interest. As part of the settlement, Jazz and Lundbeck each entered 5-year corporate integrity agreements, which require the companies to implement measures to promote independence from any patient assistance programs to which they donate. The Justice Department said Alexion was not required to enter into corporate integrity agreement because it has made organizational changes, such as hiring a new executive leadership team. The Justice Department noted that the claims in the settlement are allegations and there has been no determination of liability. (Click for more...) Rite Aid will sell CBD products in 2 states, stop selling e-cigarettes in all stores 4/12/2019 7:05:01 PM Rite Aid will sell CBD products in 2 states, stop selling e-cigarettes in all stores Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 Rite Aid reports it will start selling CBD creams, lotions, and lip balms in Washington and Oregon this month, testing public demand for cannabis-based consumer products. Walgreens and CVS also recently introduced similar products in some of their stores. Community pharmacies are evaluating the market, as federal health officials craft new regulations overseeing the CBD industry. Lawmakers legalized CBD derived from hemp in 2018, though FDA does not allow companies to add it to food or sell it as a dietary supplement. Creams, lotions, and other products applied to the skin are likely a safer first step for pharmacies. Rite Aid also indicated it will stop selling e-cigarettes. "While many feel [e-cigarettes] are beneficial to those of legal age who are trying to quit the use of tobacco, we have made the decision to remove all electronic cigarettes and vaping products from our offering at all Rite Aid stores," says Rite Aid Chief Operating Officer Bryan Everett. CVS Health stopped selling cigarettes nearly 5 years ago, while Walgreens continues to do so. Critics have said health-focused community pharmacies should not sell products that are the leading cause of preventable death. (Click for more...) FDA orders important safety labeling changes for flibanserin 4/12/2019 7:05:01 PM FDA orders important safety labeling changes for flibanserin Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 Following a review of postmarketing studies, FDA has ordered a safety labeling change order for flibanserin (Addyi—Sprout Pharmaceuticals). The order requires Sprout to revise key safety information that women and their health care professionals should have when considering use of the drug. Flibanserin's labeling currently includes a boxed warning which says that alcohol must be avoided in women treated with the drug. FDA also required a risk evaluation and mitigation strategy (REMS) that requires health care professionals who prescribe flibanserin and pharmacies that dispense it must be certified with the flibanserin REMS program and that patients must be advised about the risk of hypotension and syncope. Based on the postmarketing studies, however, FDA said that flibanserin's labeling should clarify that there is still a concern about consuming alcohol close in time to taking the drug, but that it does not have to be avoided completely. The boxed warning, contraindication, warnings and precautions, and adverse reactions sections will be updated to reflect that women should stop drinking alcohol at least 2 hours before taking flibanserin at bedtime or to skip the dose that evening. FDA noted that it is "ordering a safety labeling change requiring Sprout to make these changes because the agency was not able to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labeling. The FDA determined, based on a careful review of available data, that removing this important safety information was not acceptable for the protection of public health." (Click for more...) Herbal drug kratom linked to almost 100 overdose deaths, CDC says 4/12/2019 7:05:01 PM Herbal drug kratom linked to almost 100 overdose deaths, CDC says Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 A new CDC report indicates that kratom, a plant grown in Southeast Asia and often sold OTC in powder capsules, has been connected with more deaths in recent years. According to CDC, kratom was a cause of death in 91 overdoses in the United States from July 2016 to December 2017. In seven cases, kratom was the only substance to test positive in a toxicology report, though other substances could not be ruled out, CDC said. Of the more than 27,000 overdose deaths during that time frame, 152 of the deceased tested positive for kratom, even when not a cause of death. Health officials previously only knew of 44 deaths nationally, according to the Associated Press. In the new CDC report, in about 80% of the deaths linked to kratom the individual had a history of using other drugs, while in 90% they were not being treated by a physician for pain. CDC noted that in the majority of the kratom-related overdoses, fentanyl was also listed as a cause of death. (Click for more...) Randomized trial of verubecestat for prodromal Alzheimer disease 4/12/2019 7:05:01 PM Randomized trial of verubecestat for prodromal Alzheimer disease Thu, 04/11/2019 - 20:00 cbaker_admin Fri, 04/12/2019 - 19:05 Researchers compared outcomes with verubecestat and with placebo in patients with prodromal Alzheimer disease. This population, who present with impaired memory and elevated brain amyloid levels but do not satisfy the clinical parameters for a dementia diagnosis, is ideal for evaluating drugs that alter the deposition of amyloid on the brain before dementia sets in. Among participants who completed the entire 104 weeks of the trial, 234 were randomized to receive 12 mg of daily verubecestat, which inhibits production of amyloid-beta. Another 231 patients received 40 mg per day of the study drug, and 239 received placebo. The main outcome was mean change from baseline on the Clinical Dementia Rating Scale–Sum of Boxes score, which came in at 1.65 for the lower-dose verubecestat group, 2.02 for the higher-dose group, and 1.58 for the controls. Additionally, the estimated rate of progression to dementia due to Alzheimer disease, as measured in 100 patient–years, was 24.5, 25.5, and 19.3 events, respectively. The results of the study, which was terminated early due to futility, showed that verubecestat did not improve clinical ratings of dementia among patients with prodromal Alzheimer disease. Participants taking the study drug were more likely to experience adverse events than were the patients taking placebo, and some data even suggested that cognition and daily function were worse with verubecestat than with placebo. (Click for more...) FDA continues to investigate safety of active ingredients in hand sanitizers 4/12/2019 11:12:07 AM FDA continues to investigate safety of active ingredients in hand sanitizers Fri, 04/12/2019 - 11:14 caldridgeyoung… Fri, 04/12/2019 - 11:12 The agency said it also needs more information on three other active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—to help verify that products with these ingredients are safe and effective for regular use by consumers. FDA said it does not intend to take action at this time to remove from the market hand sanitizers that contain these three active ingredients. Ethyl alcohol is the most common ingredient in hand sanitizers. (Click for more...) 2% Lidocaine Hydrochloride Topical Jelly 4/11/2019 8:00:00 PM Drug: 2% Lidocaine Hydrochloride Topical Jelly, Revision Date: Fri, 12 Apr 2019 (Click for more...) Ampicillin Sodium and Sulbactam Sodium Injection 4/11/2019 8:00:00 PM Drug: Ampicillin Sodium and Sulbactam Sodium Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Atropine Ophthalmic Solution 4/11/2019 8:00:00 PM Drug: Atropine Ophthalmic Solution, Revision Date: Fri, 12 Apr 2019 (Click for more...) Bumetanide Injection 4/11/2019 8:00:00 PM Drug: Bumetanide Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Calcitriol Injection 4/11/2019 8:00:00 PM Drug: Calcitriol Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Diltiazem Extended-Release Capsules (Twice-Daily Dosing) 4/11/2019 8:00:00 PM Drug: Diltiazem Extended-Release Capsules (Twice-Daily Dosing), Revision Date: Fri, 12 Apr 2019 (Click for more...) Erythromycin Ophthalmic Ointment 4/11/2019 8:00:00 PM Drug: Erythromycin Ophthalmic Ointment, Revision Date: Fri, 12 Apr 2019 (Click for more...) Gentamicin Sulfate Ophthalmic Ointment 4/11/2019 8:00:00 PM Drug: Gentamicin Sulfate Ophthalmic Ointment, Revision Date: Fri, 12 Apr 2019 (Click for more...) Hydroxyethyl Starch in Sodium Chloride Injection 4/11/2019 8:00:00 PM Drug: Hydroxyethyl Starch in Sodium Chloride Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Labetalol Injection 4/11/2019 8:00:00 PM Drug: Labetalol Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Midodrine Tablets 4/11/2019 8:00:00 PM Drug: Midodrine Tablets, Revision Date: Fri, 12 Apr 2019 (Click for more...) Octreotide Injection 4/11/2019 8:00:00 PM Drug: Octreotide Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Olanzapine Intramuscular Injection 4/11/2019 8:00:00 PM Drug: Olanzapine Intramuscular Injection, Revision Date: Fri, 12 Apr 2019 (Click for more...) Proparacaine Hydrochloride Ophthalmic Solution 4/11/2019 8:00:00 PM Drug: Proparacaine Hydrochloride Ophthalmic Solution, Revision Date: Fri, 12 Apr 2019 (Click for more...) Spironolactone Tablets 4/11/2019 8:00:00 PM Drug: Spironolactone Tablets, Revision Date: Fri, 12 Apr 2019 (Click for more...) Diclofenac 0.1% Ophthalmic Solution 4/11/2019 8:00:00 PM Drug: Diclofenac 0.1% Ophthalmic Solution, Revision Date: Fri, 12 Apr 2019 (Click for more...) FDA warns public not to use unapproved, uncleared medical devices to help assess or diagnose a concussion 4/11/2019 6:05:01 PM FDA warns public not to use unapproved, uncleared medical devices to help assess or diagnose a concussion Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Consumers should not use medical devices marketed to the public that claim to help assess, diagnose, or manage head injuries, including concussion, traumatic brain injury (TBI), or mild TBI, according to FDA. On Wednesday, the agency issued a new safety communication warning that such tools have not been reviewed by FDA for safety and efficacy and could lead to an incorrect diagnosis. At present, there are a limited number of medical devices that have received FDA approval to aid in the diagnosis, treatment or management of concussion- and all require an evaluation by a health care professional. "I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger," said Jeffrey Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health. FDA said that the products of concern include ones that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or cognitive status. (Click for more...) Association among dietary supplement use, nutrient intake, and mortality among U.S. adults 4/11/2019 6:05:01 PM Association among dietary supplement use, nutrient intake, and mortality among U.S. adults Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Research out of Tufts University looked at the relationship between dietary supplement use, levels of nutrient intake from foods and supplements, and U.S. adult mortality. NIH funded the study, which consulted both the National Health and Nutrition Examination Survey and the National Death Index from 1999–2010. Based on data for nearly 31,000 individuals aged 20 years and older, a total of 3,613 died over a median 6.1 years of followup. Of those deaths, 945 were blamed on cardiovascular disease (CVD) and 805 were attributed to cancer. Use of dietary supplements at any time did not improve mortality outcomes, and excessive intake of calcium from supplements was actually associated with an elevated risk of cancer death. On the other hand, sufficient food-derived intake of vitamins A and K, magnesium, zinc, and copper was correlated with lower rates of all-cause mortality or death due CVD. (Click for more...) Association of HIV PrEP with incidence of STIs among individuals at high risk of HIV 4/11/2019 6:05:01 PM Association of HIV PrEP with incidence of STIs among individuals at high risk of HIV Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Research out of Australia adds to mounting evidence that gay and bisexual men are more vulnerable to STIs after they begin HIV preexposure prophylaxis (PrEP). Enrollees—nearly 3,000 in all—received oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP each day, HIV and STI testing every quarter, and clinical monitoring. At a mean followup of 1.1 years, almost one-half of the sample population had been diagnosed with chlamydia, gonorrhea, or syphilis. The incidence of STI was 91.9 per 100 person-years, with an estimated one-quarter of the study participants accounting for about three-quarters of the cases. Among 2,058 patients with complete data for multivariable analysis, the risk of STI increased with younger age and increased number of partners. Among 1,378 participants with preenrollment testing data, meanwhile, STI incidence increased significantly from 1 year ahead of the study to followup, after adjusting for testing frequency. Investigators say the results underscore the importance of frequent STI testing among gay and bisexual men using PrEP. (Click for more...) Gout treatment may help prevent obesity-related type 2 diabetes, suggests small NIH study 4/11/2019 6:05:01 PM Gout treatment may help prevent obesity-related type 2 diabetes, suggests small NIH study Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 A study by NIH researchers suggests that colchicine, used to treat gout, could potentially help curb complications related to metabolic syndrome—the combination of hypertension, high blood sugar, and other conditions that raise the risk of heart disease and type 2 diabetes. Researchers led by Jack A. Yanovski, MD, PhD, of NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, randomly assigned 21 participants to receive colchicine twice a day for 3 months, while 19 participants received a placebo. Colchicine suppresses a multi-protein complex called NLRP3, which triggers the inflammation related to obesity. Researchers examined measures that indicate how well insulin clears sugar from the blood. When insulin-modified I.V. glucose tolerance tests were conducted, there was no difference between the two groups in insulin resistance. However, the colchicine group showed improvement on the Homeostatic Model Assessment of Insulin Resistance test, which also estimates how much insulin is needed to keep blood sugar at a normal level while fasting. Individuals in the colchicine group also scored lower on a blood test of C-reactive protein and other tests that indicate inflammation. The authors, who report their findings in Diabetes, Endocrinology, and Metabolism, said that larger-scale testing is necessary to ascertain if colchicine could prevent the development of type 2 diabetes in people with metabolic syndrome. (Click for more...) Sanofi to cut U.S. insulin costs for some patients to $99 per month 4/11/2019 6:05:01 PM Sanofi to cut U.S. insulin costs for some patients to $99 per month Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Sanofi SA is expanding its Insulin Valyou Savings Program and will allow uninsured patients in the United States to purchase up to 10 boxes of insulin pens or vials with a valid prescription for $99 per month, beginning in June. The price of other manufacturers' leading insulin products is $178–$300 per vial and $235–$563 per pack of pens, according to Sanofi. Last month, Eli Lilly announced plans to sell an authorized generic version of its insulin lispro recombinant (Humalog) for $137.35 per vial. (Click for more...) CareSource announces major business change 4/11/2019 6:05:01 PM CareSource announces major business change Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 In Dayton, OH, health insurance company CareSource announced plans to migrate to a new PBM and make other changes in how it operates pharmacy services. CareSource, which chiefly manages private Medicaid plans, says it will contract with Express Scripts, instead of CVS Caremark in January 2020. CareSource believes its new approach will drive pharmacy savings for states by providing price transparency validated by a third-party. States will have "full visibility to where pharmacy dollars are being spent for their Medicaid beneficiaries," the company said. CareSource will also reward pharmacists for going beyond the filling and handling prescriptions. "If you think about the average member, typically they actually visit their pharmacist more than perhaps any other provider," said CareSource president and CEO Erhardt Preitauer. CareSource will use a platform for analyzing data that will let users see when each prescription is written along with behavioral health and medical data. "Our care managers are really going to be able to drive care where and when it needs to be in a way that we've not been able to do before," said Preitauer. (Click for more...) Biogen SMA drug price, Novartis estimates for its treatment far too high: ICER 4/11/2019 6:05:01 PM Biogen SMA drug price, Novartis estimates for its treatment far too high: ICER Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 A report by the nonprofit Institute for Clinical and Economic Review (ICER) said Biogen should cut the price of its spinal muscular atrophy (SMA) drug, nusinersen (Spinraza). ICER also said Novartis has excessively valued its experimental gene therapy for SMA, which the company says is worth $4 million–$5 million. Novartis has not set a price for onasemnogene abeparvovec (Zolgensma—Novartis), which could gain U.S. approval in May. Using the quality-adjusted life–year (QALY) benchmark, ICER said nusinersen would need to cost between $72,000 and $130,000 for the first year of treatment, and cost $36,000–$65,000 per year after that, for infants not yet showing symptoms of the disease. Nusinersen's current list price is $750,000 for the initial year and $375,000 annually thereafter. With an alternative benchmark known as life-year gained (LYG), nusinersen is worth $83,000–$145,000 in year one, and $41,000–$72,000 annually thereafter, ICER determined. Onasemnogene abeparvovec would be worth $310,000–$900,000 for Type 1 SMA patients based on the QALY assessment, and $710,000–$1.5 million using the LYG calculation, ICER said. ICER chief medical officer David Rind said, "These treatments will be covered by U.S. insurers regardless of the pricing, but the ripple effect of pricing decisions like these threatens the overall affordability and sustainability of the U.S. health system. (Click for more...) Pharma lobbyists flooded Maryland to block a drug-pricing bill, but lost 4/11/2019 6:05:01 PM Pharma lobbyists flooded Maryland to block a drug-pricing bill, but lost Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Drug pricing advocates celebrated on Monday when, with an hour remaining before the 2019 Maryland legislative session expired, lawmakers passed a first-of-its kind law to create a state board that could cap payments for ultra-expensive prescription drugs. Pharmaceutical industry representatives had warned the legislation would leave cancer patients without cutting-edge treatments or cause a mass exodus of state employees. They also suggested the new law would be challenged a court. Even so, barring a veto from the state's governor, the creation of a "drug affordability board," which would take effect in 2022, is one of the most visible manifestations of the nationwide political momentum to bring down high drug costs. "We've got a national model here," said Vinny DeMarco, a public-health advocate and lobbyist who was the bill's chief proponent in Annapolis. DeMarco's group—the Maryland Citizens’ Health Initiative, an advocacy group backed by an array of nonprofits—provided much of the funding and political heft behind the campaign. Drugmakers did win two major concessions. While early proposals affected all payers, including private insurers, the final will only touch public-sector insurers serving city, county, and state government employees. Also, before the board enacts a payment limit, it will have to ask permission from legislative leaders. (Click for more...) Drugmaker petitions FDA to revoke orphan designation 4/11/2019 6:05:01 PM Drugmaker petitions FDA to revoke orphan designation Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 The drug manufacturer Braeburn is asking FDA to revoke the orphan designation granted to Indivior’s opioid use disorder treatment buprenorphine extended-release injection (Sublocade), asserting in a filing it "is not now, nor was it ever a bona fide orphan drug, particularly since more than 2 million Americans currently are afflicted by opioid addiction." In December, FDA tentatively approved Braeburn’s own buprenorphine extended-release injection drug Brixadi, though the company is unable to market the drug during Sublocade’s 3-year exclusivity period which expires in November 2020. If Sublocade receives orphan drug exclusivity as well, Braeburn would be barred from marketing its drug until 2024. Braeburn's petition claims that the cost recovery analysis used to justify the orphan designation was "inaccurate and misleading" as Subutex brought in more than $285 million in sales since its approval in 2002. (Click for more...) Azar's remarks to the NCPA 4/11/2019 6:05:01 PM Azar's remarks to the NCPA Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 In a speech to the National Community Pharmacists Association (NCPA) on Wednesday, HHS Secretary Alex Azar discussed the key role of community pharmacists in the health care arena. "I've been aware of the important role community pharmacists play in our health care system throughout my career," he said. "In just the last year, as Secretary, I've been able to visit two community pharmacies to hear from pharmacists and their customers." He added that during his time in the private sector, he "saw just how trusted and valued pharmacists are, often serving as the most frequent point of contact many Americans have with our health system." Azar also discussed three initiatives that were put forth in President Trump's blueprint for lowering prescription drug prices and out-of-pocket costs last May. These initiatives focus on pharmacy gag clauses, DIR fees, and replacing the rebate system with a system of upfront discounts, delivered at the pharmacy counter. According to Azar, "Each step we're taking as part of the president's blueprint, from improving negotiation to creating more transparency around pricing and promoting generic competition, is important on its own and in concert with one another. But none of our efforts will be as useful as they can be if we leave alone today's system of backdoor rebates." In discussing the part pharmacists hold in today's health care system, he stated that "a broader role for pharmacists is important not just because it can mean more convenient, lower cost care for American patients. It also represents a positive trend in our health care system, of thinking more expansively about what kinds of care can be provided by all kinds of health professionals." (Click for more...) CDC clarifies opioid prescribing guideline 4/11/2019 6:05:01 PM CDC clarifies opioid prescribing guideline Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 CDC advises that doctors who prescribe opioids for cancer, palliative, and end-of-life care should do so according to clinical practice guidelines crafted just for those scenarios. The position was spelled out by the chief medical officer of the CDC National Center for Injury Prevention and Control in a letter to three national cancer organizations. The correspondence from Deborah Dowell, MD, was intended to clarify CDC's "Guideline for Prescribing Opioids for Chronic Pain," which the groups feared would shut out patients with chronic pain during cancer treatment, cancer survivors with ongoing pain, and sickle cell patients. Pain management in each of these circumstances entails "unique therapeutic goals and balance of risks and benefits with opioid therapy," Dowell wrote to the American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and American Society of Hematology (ASH). She emphasized that the recommendations are not meant to eliminate opioids as an option for patients in need, but to ensure that all safe and effective treatment options are taken into consideration. "This clarification from CDC is critically important because, while the agency's guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations," said ASCO CEO Clifford A. Hudis, MD. (Click for more...) Lawmakers in both parties vow to rein in insulin costs 4/11/2019 6:05:01 PM Lawmakers in both parties vow to rein in insulin costs Wed, 04/10/2019 - 20:00 cbaker_admin Thu, 04/11/2019 - 18:05 Members of Congress from both parties on Wednesday vowed to work together on legislation to prevent more people from dying because they cannot afford insulin. Rep. Earl "Buddy" Carter (R-GA) said at the end of a 3-hour hearing with pharmaceutical and PBM executives, "You've done something here today that we've been trying to do in Congress for years, and that is to create bipartisanship. This is going to end," Carter said of the arrangements that drive up list prices of insulin and the out-of-pocket costs for many people with diabetes. Rep. Jan Schakowsky (D-IL) concurred, noting that "on both sides of the aisle, there is a commitment" to end price gouging by insulin manufacturers. Insulin manufacturers said that prices are going up, in part, because they had made many improvements in insulin products, leading to better treatment and longer lives for people with diabetes. Executives from the drug makers said they could not reduce list prices because it was not feasible to do so in "the system" as it now exists. In that system, they said, PBMs and insurance companies demand discounts, rebates, and other price concessions that are calculated as a percentage of the list price. And they provide the concessions to guarantee that their drugs will be covered. They added that the net price they received for insulin—after discounts and rebates—was declining, even as the list prices were rising. (Click for more...) New practice guideline outlines safe use of propofol in ED 4/11/2019 10:19:43 AM New practice guideline outlines safe use of propofol in ED Thu, 04/11/2019 - 10:29 caldridgeyoung… Thu, 04/11/2019 - 10:19 In a clinical practice guideline published in the February 2019 issue of Annals of Emergency Medicine, a team of emergency physicians evaluated literature published between 2007 and 2018 related to propofol use in emergency departments (EDs). (Click for more...) Clindamycin Phosphate Injection 4/10/2019 8:00:00 PM Drug: Clindamycin Phosphate Injection, Revision Date: Thu, 11 Apr 2019 (Click for more...) Dicyclomine Oral Presentations 4/10/2019 8:00:00 PM Drug: Dicyclomine Oral Presentations, Revision Date: Thu, 11 Apr 2019 (Click for more...) Lorazepam Injection 4/10/2019 8:00:00 PM Drug: Lorazepam Injection, Revision Date: Thu, 11 Apr 2019 (Click for more...) Verapamil Extended-Release Tablets 4/10/2019 8:00:00 PM Drug: Verapamil Extended-Release Tablets, Revision Date: Thu, 11 Apr 2019 (Click for more...) Amino Acid Products 4/10/2019 8:00:00 PM Drug: Amino Acid Products, Revision Date: Thu, 11 Apr 2019 (Click for more...) FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture 4/10/2019 5:05:01 PM FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 FDA approved on Tuesday romosozumab-aqqg (Evenity—Amgen) for the treatment of osteoporosis in postmenopausal women at high risk of fracture. These women have a history of osteoporotic fracture or multiple risk factors for fracture, or they have failed or are intolerant of other osteoporosis treatments. One dose of romosozumab-aqqg—a monoclonal antibody that blocks the effects of the sclerostin protein—consists of two injections, one after the other, administered once a month by a health care professional. Because the bone-forming effect of the drug wanes after 12 doses, FDA notes that more than 12 doses should not be used. Women who need additional treatment should begin an osteoporosis treatment that reduces bone breakdown. In the clinical trials used to demonstrate the safety and efficacy of romosozumab-aqqg, the drug increased the risk of cardiovascular death, heart attack, and stroke in the trial using alendronate, another osteoporosis therapy, but not in the placebo trial. Romosozumab-aqqg includes a boxed warning that states it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year. Common adverse effects associated with the drug included joint pain and headache. (Click for more...) FDA identifies harm reported from sudden discontinuation of opioid pain medicines 4/10/2019 5:05:01 PM FDA identifies harm reported from sudden discontinuation of opioid pain medicines Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 FDA warned Tuesday that it has received reports of serious harm in patients who are physically dependent on opioid analgesics and who suddenly have these medicines discontinued or the dose rapidly reduced. The effects include severe withdrawal symptoms, uncontrolled pain, psychological distress, and suicide. The agency said it will "continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines," and it is mandating changes to the prescribing information for these products that are intended for use in the outpatient setting. The changes, said FDA, "will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued." According to FDA, health care providers should not suddenly discontinue opioids in a patient who is physically dependent. When they and their patient have agreed to taper the dose, several factors should be considered, including the dose of the drug, the length of treatment, the type of pain being treated, and the patient's physical and psychological attributes. "No standard opioid tapering schedule exists that is suitable for all patients," FDA cautioned. "Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient's pain, or psychological distress." The agency also advised patients taking opioid analgesics long-term not to abruptly stop taking their medicine without first discussing with their health care provider a plan to slowly taper use of the drug and manage their pain. (Click for more...) Measles outbreak: New York declares health emergency, requiring vaccinations in parts of Brooklyn 4/10/2019 5:05:01 PM Measles outbreak: New York declares health emergency, requiring vaccinations in parts of Brooklyn Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 New York City Mayor Bill de Blasio on Tuesday declared a public health emergency that would require unvaccinated individuals living in Williamsburg, Brooklyn, to receive the measles vaccine. City officials have been fighting a measles outbreak in ultra-Orthodox Jewish communities in Brooklyn for months, knowing that the measles vaccine was not reaching its target audience. They tried education and outreach, as well as a ban on unvaccinated students from going to school. In his emergency declaration, the mayor said the city would issue violations and possibly fines of $1,000 for those who did not comply. "This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately," de Blasio said, adding: "The measles vaccine works. It is safe, it is effective, it is time-tested." The measure follows a spike in measles infections in New York City, where there have been 285 confirmed cases since the outbreak began in the fall; 21 of those cases led to hospitalizations, including five admissions to the intensive care unit. To enforce the order, health officials said they did not intend to perform random spot checks on students; instead, as new measles cases arose, officials would check the vaccination records of any individuals who were in contact with those infected. (Click for more...) Effect of vitamin D supplementation on relapse-free survival among patients with digestive tract cancers 4/10/2019 5:05:01 PM Effect of vitamin D supplementation on relapse-free survival among patients with digestive tract cancers Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 For patients with digestive tract cancer, supplementation with vitamin D did not lead to substantial improvement in relapse-free survival at 5 years compared with placebo, according to new research. For the AMATERASU trial, a team of Japanese researchers studied more than 400 patients with cancers of the digestive tract from the esophagus to the rectum, stages I to III. Participants were randomized to receive vitamin D capsules (2000 IU/d) or placebo from the first postoperative outpatient visit to until the end of the trial. The primary outcome was relapse-free survival time to relapse or death, while the secondary outcome was overall survival time to death from any cause. Over a median followup of 3.5 years, the primary outcome occurred in 20% (50 of 251 patients) in the vitamin D group and 26% (43 of 166) of the placebo group. Death occurred in 15% of each group, while the 5-year relapse-free survival was 77% and 69%, respectively. The 5-year overall survival rates in the two groups were 82% and 81%, respectively. A subgroup of patients with baseline serum 25(OH)D levels between 20 and 40 ng/mL had 5-year relapse-free survival rates of 85% in the vitamin D group and 71% with placebo. A total of 8 patients (3 in the vitamin D group and 5 in the placebo group) reported fractures, while 2 patients in the vitamin D group also experienced urinary stones. (Click for more...) Bartell offers vaccinations, education for international travelers 4/10/2019 5:05:01 PM Bartell offers vaccinations, education for international travelers Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Bartell Drugs announced that, at 57 of its locations, it will provide a customized medical travel plan for any destination. The company's travel consultant pharmacists can also prescribe and administer travel vaccines, including those for typhoid, cholera, hepatitis A, yellow fever, and tetanus. As part of the appointment, patients will be able to receive personalized information about their destination and any potential health-related scenarios. The travel pharmacists will be available to make recommendations for any needed vaccines or medications based on the patient's health history and travel destination. "With the recent resurgence of illnesses like measles and typhoid fever, vaccinations are top of mind," said Billy Chow, Bartell's vice president of pharmacy. "Many of the illnesses potentially encountered in other countries can be prevented. Get the most out of your travel. Stay healthy and focus on the reason for your travels." (Click for more...) Butler pharmacists develop tool to guide insurers on drug formularies 4/10/2019 5:05:01 PM Butler pharmacists develop tool to guide insurers on drug formularies Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Butler University in Indiana has developed a tool to help insurers as they develop their formularies that will fulfill federal laws of not discriminating against patients with certain diseases. Butler said it was approached by the Indiana Department of Insurance to develop a list of medicines that insurance companies should cover for 17 disease areas, including schizophrenia, sleep disorder, and depression. Insurance companies have broad latitude to decide which treatments and medicines to cover; however, Indiana was looking for a more rigorous approach as well as to ensure insurance carriers were covering an adequate amount of prescription drugs. Butler assembled a group of faculty, students, and alumni to study the issue. The team built a database tool that considered the latest research, published literature, federal regulatory approvals, and clinical experience. The goal was to bridge the gap between the regulators, insurance companies, and clinicians, as well as reduce prior authorizations and delays on drugs that should be part of the front-line regimen for certain diseases. Pharmacists considered the pros and cons for patients, to make sure the right medicine would be available for the right people. Pharmacists also gave insurance companies and state regulators some discretion, especially for diseases and treatments that are still evolving. (Click for more...) Expanding pharmacist and student pharmacist access to genetics/genomics/pharmacogenomics competency education 4/10/2019 5:05:01 PM Expanding pharmacist and student pharmacist access to genetics/genomics/pharmacogenomics competency education Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Researchers from Manchester University, in Fort Wayne, IN, and Presbyterian College, in Clinton, SC, sought to evaluate pharmacists' and student pharmacists' self-assessed perception of competence in relation to genetics, genomics, and pharmacogenomics (PGx), as presented using an online PGx certification program. The program included three background lessons and eight specific drug-gene lessons delivered in the context of 16 pharmacist competency statements. Additionally, there were 11 video modules with competency-related PGx content, with pre- and post-course surveys used to evaluate participants' self-assessed perception of competence related to each of the statements. After taking the program, the participants reported self-perceived improved skills for each of the genetics/genomics-related competency statements. The researchers observed similar outcomes for the subsets of student and professional pharmacists. "This delivery approach can expand genetics/genomics/pharmacogenomics content dissemination," the authors conclude. "The intent is to reach a broader population of pharmacy students, pharmacists, and other health care providers and health professions students to potentially advance the availability of such services, which can improve the safety and efficacy of medication use for patients." (Click for more...) CVS, Cigna, Humana blame Big Pharma at Senate hearing for skyrocketing U.S. drug prices 4/10/2019 5:05:01 PM CVS, Cigna, Humana blame Big Pharma at Senate hearing for skyrocketing U.S. drug prices Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Testifying before a Senate Finance Committee hearing, PBM executives on Tuesday denied that the industry's so-called backdoor deals with drug manufacturers are responsible for the increasingly higher prices patients pay for medication. They blamed high drug prices on the drugmakers, citing as an example the high cost of insulin, a nearly 100-year-old medication, which has nearly doubled in price from 2012 to 2016 to $5,700 from $2,900. The executives—from CVS Health, Cigna, Prime Therapeutics, Humana, and UnitedHealthcare's OptumRx—said rebates paid by drug companies to PBMs are not secret payments as some lawmakers in Congress insist. CVS said rebates are actually "a powerful tool used to offset" the high list prices set by pharmaceutical companies. "A major factor contributing to the increase in drug spending is the list price of prescription drugs. Drug manufacturers alone set the list price of prescription drugs," said William Fleming, president of health care services at Humana. "Drug manufacturers raise list prices to boost their revenue." The hearing Tuesday, led by Chairman Sen. Chuck Grassley (R-IA) and ranking Democrat Sen. Ron Wyden (D-OR), marks the committee's third on drug prices this year. (Click for more...) U.S. charges drug manufacturer Indivior with organizing multibillion-dollar fraud 4/10/2019 5:05:01 PM U.S. charges drug manufacturer Indivior with organizing multibillion-dollar fraud Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 The U.S. Department of Justice on Tuesday charged the U.K. pharmaceutical company Indivior with organizing a multibillion-dollar fraud to drive up sales of its opioid-addiction treatment buprenorphine and naloxone (Suboxone Film). Indivior set up a telephone and online program intended to connect callers with doctors that the drugmaker knew were prescribing opioids in a "careless and clinically unwarranted manner," according to the indictment. Prosecutors are seeking at least $3 billion and control of other property from Indivior, previously the pharmaceuticals business of Reckitt Benckiser Group. Indivior, which became a stand-alone company in 2014, denied the charges and said it worked with the Department of Justice for years as part of its investigation and "made numerous attempts to reach a settlement that went far beyond what we believe the facts of this case support." (Click for more...) Hospital responses to the End of Life Option Act 4/10/2019 5:05:01 PM Hospital responses to the End of Life Option Act Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Researchers polled California hospitals to measure the level of participation in the state's End of Life Option Act (EOLOA) 18 months after its passage. The legislation gives terminally ill adults the right, under certain circumstances, to request a prescription for medication to accelerate death. A total of 315 hospitals were asked to complete an anonymous telephone survey from September 2017 to March 2018, with 270 ultimately taking part. Responding hospitals were covered by 89 unique policies, 54 of which banned the EOLOA and 35 that sanctioned the law. Additionally, 53 of those policies applied to all inpatient and outpatient facilities under the health system; while 36 applied to hospitals, with no additional information on outpatient facilities. Only 235 of the 270 hospitals queried, however, incorporated formal, written rules. Overall, 106 of the 270 allowed physicians to write EOLOA prescriptions; but 164 explicitly banned them from doing so. Hospitals opting out of the EOLOA, meanwhile, accounted for 48% of all hospital discharges in 2016. Other survey findings indicate that hospitals the most receptive to the EOLOA were less likely to have religious affiliations and were more likely to have nonprofit status and to provide palliative care and bereavement services. (Click for more...) DeSantis pushes for Floridians to be allowed to buy prescription drugs from Canada 4/10/2019 5:05:01 PM DeSantis pushes for Floridians to be allowed to buy prescription drugs from Canada Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 A plan unveiled by Gov. Ron DeSantis of Florida would make it legal for state residents to import medicine from Canada. DeSantis said, "We identified a federal law that allows for states to bring in drugs from Canada if the facilities are FDA approved. The whole purpose is, if you have Canada drugs, the same drug costs 25% of what it costs here. We want Floridians to be able to share in those discounts." DeSantis said he has already received support from President Trump and Florida lawmakers in both the state House and Senate. Some lawmakers estimate the plan would help save Floridians as much as 80% on their prescription costs. However, critics warn that importing drugs from another country could lead to an increase in counterfeit drugs. DeSantis noted that facilities in Canada would still have to be FDA-approved. He said, "This program only applies if we are showing that we are bringing drugs in that are safe and that are less expensive than what we already have." Such a plan, even if approved by Florida legislators, would require federal government approval as well. (Click for more...) FDA warns Virginia genomics lab for illegally marketing genetic test 4/10/2019 5:05:01 PM FDA warns Virginia genomics lab for illegally marketing genetic test Tue, 04/09/2019 - 20:00 cbaker_admin Wed, 04/10/2019 - 17:05 Inova Genomics Laboratory, based in Falls Church, Va., has received a warning letter from the Food and Drug Administration (FDA) for illegally marketing certain genetic tests. The tests claim to predict patients' clinical responses to specific named drugs, including antidepressants, opioids, cancer treatments, anesthesia, and diabetes medications. However, these tests have not been reviewed by the FDA for safety and effectiveness. Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, said: "Without appropriate evaluation to determine whether these tests work, patients are being put at risk—potentially impacting treatment decisions by providing false promise that they will respond well to a certain medicine or keeping them from using therapies that may benefit them." FDA has not reviewed, nor is it aware of any data establishing that Inova's tests can help patients or health care providers use the listed drugs more safely or effectively. The warning letter requests Inova to respond within 15 working days, with details of how the violations noted in the warning letter will be corrected. (Click for more...) FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture 4/9/2019 6:23:25 PM Generic Name: Romosozumab-aqqgTrade Name: EvenityCompany: AmgenNotes: FDA approved romosozumab-aqqg to treat osteoporosis in postmenopausal women at high risk of fracture. Women at high risk have a history of osteoporotic fracture or multiple risk factors for fracture, or have experienced treatment failure or intolerance to other osteoporosis therapies. Romosozumab-aqqg is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation. One dose consists of two injections, one immediately following the other, given once a month by a health professional. The bone-forming effect wanes after 12 doses, so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown. Safety and efficacy of the agent were demonstrated in two clinical trials involving a total of more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with romosozumab-aqqg lowered the risk of a new vertebral fracture by 73% compared with placebo. This benefit was maintained over the second year of the trial, when the agent was followed by 1 year of denosumab (another osteoporosis therapy) compared with placebo followed by denosumab. In the second trial, one year of treatment followed by 1 year of alendronate (another osteoporosis therapy) reduced the risk of a new vertebral fracture by 50% compared with 2 years of alendronate alone. Romosozumab-aqqg followed by alendronate also reduced the risk of fractures in nonvertebral fractures compared with alendronate alone. The agent increased the risk of cardiovascular death, heart attack, and stroke in the alendronate trial but not in the placebo trial. Therefore, romosozumab-aqqg contains a boxed warning stating that it may increase the risk of heart attack, stroke, and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year. Health professionals should also consider whether the benefits of romosozumab-aqqg outweigh its risks in those with other risk factors for heart disease. The drug should be discontinued in any patient who experiences a heart attack or stroke during treatment. In clinical trials, common adverse effects included joint pain, headache, and injection-site reactions. Medication Monitor Categories: New Drug Approvals (Click for more...) First two-drug complete HIV regimen approved for never-treated patients 4/9/2019 5:52:13 PM Generic Name: Dolutegravir and lamivudineTrade Name: DovatoCompany: ViiV HealthcareNotes: FDA has approved dolutegravir and lamivudine as a complete regimen for treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of the new agent. This is the first two-drug, fixed-dose, complete regimen approved for adults with HIV-1 who have never received treatment. The labeling includes a boxed warning cautioning that patients infected with both HIV and hepatitis B should receive additional treatment for their hepatitis B or consider a different drug regimen. Patients with both HIV and hepatitis B who take products containing lamivudine, an ingredient in the new combination drug, have developed hepatitis B variants associated with resistance to lamivudine. These patients may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine. Patients with both HIV and hepatitis B virus who stop using the drug should be closely monitored by their health care provider. Efficacy and safety of one tablet of dolutegravir and lamivudine taken daily were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history. Results were similar to a drug regimen that included dolutegravir, emtricitabine, and tenofovir in reducing the amount of HIV in the blood. Treatment was considered successful if the patient maintained low levels ( The most common adverse reactions were headache, diarrhea, nausea, insomnia, and fatigue. As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of the new drug at the time of conception through the first trimester of pregnancy. In May 2018, FDA released a Drug Safety Communication about reported neural tube birth defects in babies born to women treated with dolutegravir. Medication Monitor Categories: New Drug Approvals (Click for more...) New indication of palbociclib approved to treat men with metastatic breast cancer 4/9/2019 5:04:23 PM Generic Name: PalbociclibTrade Name: IbranceCompany: PfizerNotes: FDA is extending the indication of palbociclib capsules in combination with specific endocrine therapies for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer in male patients. Palbociclib was initially approved in 2015 in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy. The most common adverse effects are infections, leukopenia fatigue, nausea, stomatitis, anemia hair loss, diarrhea, and thrombocytopenia. Other common adverse effects are rash, vomiting, decreased appetite, asthenia, and fever. Health care providers are advised to monitor a patient’s blood count for neutropenia. Patients should have their blood count checked before starting palbociclib and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated. Because of the potential for genotoxicity, health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. Women who are pregnant or breastfeeding should not take palbociclib because it may cause harm to a developing fetus or newborn baby. Medication Monitor Categories: Supplemental Approvals (Click for more...) FDA approves reintroduction of tegaserod for IBS-C in women 4/9/2019 2:40:43 PM Generic Name: TegaserodTrade Name: ZelnormCompany: Sloan Pharma/US WorldMedsNotes: US WorldMeds announced that its subsidiary, Sloan Pharma, has received FDA approval to reintroduce tegaserod, a twice-daily oral treatment for irritable bowel syndrome with constipation (IBS-C) in women younger than 65. Tegaserod was originally approved by FDA in 2002 for treatment of IBS-C in women. It was voluntarily withdrawn from the U.S. market in 2007 because of safety concerns. The drug has remained consistently available in the United States through an expanded access program authorized by FDA and is used by patients with IBS-C in several other countries. Approval to reintroduce the agent came after a complete safety review by FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on evaluation of clinical data from 29 placebo-controlled trials and newly available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported its reintroduction for appropriate patients with IBS-C. Tegaserod is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. The drug targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the GI tract to induce contraction and relaxation and decrease pain signaling. In clinical trials, patients taking tegaserod saw improvement in some of the most bothersome IBS-C symptoms. In the first 4 weeks, significantly more patients treated with tegaserod than placebo-treated patients reported an improvement in their abdominal pain/discomfort and bloating. Frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month one. Medication Monitor Categories: Supplemental Approvals (Click for more...) Fixed-dose LAMA/LABA combination approved for maintenance treatment of COPD 4/9/2019 2:18:43 PM Generic Name: Aclidinium bromide/formoterol fumarate Trade Name: DuaklirCompany: Circassia PharmaceuticalsNotes: Circassia Pharmaceuticals announced FDA approval of aclidinium bromide/formoterol fumarate for maintenance treatment of chronic obstructive pulmonary disease (COPD) under the trade name Duaklir. The agent is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg). It is administered twice daily via the breath-actuated inhaler Pressair. Approval was based on a broad clinical database, including data from three Phase III studies, ACLIFORM, AUGMENT, and AMPLIFY. The label also includes clinical data from the Phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations. As a result, Duaklir is the only twice-daily LAMA/LABA in the United States with COPD exacerbation data included in its prescribing information. Circassia plans to launch Duaklir in the United States in the second half of 2019. Medication Monitor Categories: Supplemental Approvals (Click for more...) FDA approves multiple generics, two shared-system REMS for ambrisentan 4/9/2019 1:47:52 PM Generic Name: AmbrisentanTrade Name: LetairisCompany: Multiple manufacturersNotes: FDA has approved multiple generics for ambrisentan tablets. With the approval of these first generics and their associated risk evaluation and mitigation strategy (REMS) programs, patients will now have access to additional products (brand-name and generic) and additional types of pharmacies (retail or specialty) to fill their prescriptions, according to FDA. The agency also approved two shared-system REMS programs for ambrisentan. The first, the Ambrisentan REMS (formerly the Letairis REMS), comprises the reference listed drug or brand sponsor (Letairis), as well as three abbreviated new drug applications (ANDAs, or generics). The second program, the PS-Ambrisentan REMS, currently consists of one ANDA sponsor. The PS signifies “parallel system” to assist in differentiating the programs within the market. For more information, including action items prescribers, patients, and pharmacists should complete to access these additional options, see the First Generic Drug Approvals section of FDA's website. Medication Monitor Categories: Supplemental Approvals (Click for more...) New oral treatment approved for multiple sclerosis 4/9/2019 1:35:22 PM Generic Name: CladribineTrade Name: MavencladCompany: EMD SeronoNotes: FDA approved cladribine tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Cladribine is not recommended for patients with MS who have clinically isolated syndrome. Because of its safety profile, its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for treatment of MS. The drug's efficacy was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Compared with placebo, cladribine significantly decreased the number of relapses and also reduced progression of disability. Cladribine must be dispensed with a patient Medication Guide and has a boxed warning for an increased risk of malignancy and fetal harm. It should not to be used in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, health professionals should evaluate its benefits and risks on an individual patient basis. They should also follow standard cancer screening guidelines in patients treated with cladribine. The drug should not be used in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during treatment and for 6 months after drug therapy because of the potential for fetal harm. The drug must be stopped if the patient becomes pregnant. Other warnings include the risk of decreased lymphocyte counts, hematologic toxicity, and bone marrow suppression. Health professionals should measure a patient’s complete blood counts and lymphocyte counts before, during, and after treatment. The drug may increase the risk of infections, so health professionals should screen patients for infections and delay treatment with cladribine if necessary. The drug has been associated with graft-versus-host-disease following blood transfusions with nonirradiated blood. It may cause liver injury, and treatment should be interrupted or discontinued, as appropriate, if clinically significant liver injury is suspected. The most common adverse reactions reported in the clinical trials included upper respiratory tract infections, headache, and decreased lymphocyte counts. Medication Monitor Categories: Supplemental Approvals (Click for more...) FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism 4/9/2019 1:21:38 PM Generic Name: Testosterone undecanoateTrade Name: JatenzoCompany: Clarus TherapeuticsNotes: FDA approved testosterone undecanoate, an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Testosterone undecanoate should not be used to treat men with age-related hypogonadism, in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. The drug's benefits do not outweigh its risks for that use, according to FDA. Efficacy was demonstrated in a 4-month clinical trial involving 166 men with hypogonadism. Study participants initially were given 237 mg of testosterone undecanoate twice per day, and the dose was adjusted downward or upward to a maximum of 396 mg twice per day on the basis of testosterone levels. Eighty-seven percent of men treated with the drug achieved an average testosterone level within the normal range, which was the primary study endpoint. Testosterone undecanoate contains a boxed warning stating that the drug can cause blood pressure to rise, increasing the risk of heart attack, stroke, and cardiovascular death. Health care providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing the agent. They should also periodically monitor patient blood pressure during treatment. The drug is currently one of two testosterone products that have this boxed warning. FDA is requiring all testosterone product manufacturers to conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure. Common adverse effects, occurring in more than 2% of patients in the clinical trial, included headache, an increase in red blood cell count, a decrease in HDL-C, high blood pressure, and nausea. An increase in prostate specific antigen (PSA) was also observed. Patients should have their hematocrit, cholesterol, and PSA monitored regularly to check for changes. Those with benign prostate hyperplasia should be monitored for worsening of symptoms. Medication Monitor Categories: New Drug Approvals (Click for more...) FDA takes major step to lower insulin prices 4/9/2019 12:31:02 PM FDA takes major step to lower insulin prices Tue, 04/09/2019 - 12:34 caldridgeyoung… Tue, 04/09/2019 - 12:31 FDA explained that this transition will allow biosimilar insulin products and substitutes to come to market for the first time, stimulating competition and hopefully lowering the drug’s prices. The price of insulin has been a pressing issue in public minds, especially among patients with diabetes, pharmacists, and physicians. While the medication has been around for nearly a century, its price continues to skyrocket by double digits annually. (Click for more...) Pediatric telemedicine visits yielded more antibiotic prescriptions, study finds 4/9/2019 10:40:01 AM Pediatric telemedicine visits yielded more antibiotic prescriptions, study finds Tue, 04/09/2019 - 10:47 caldridgeyoung… Tue, 04/09/2019 - 10:40 “As a general pediatrician, I’m interested in making care easier and less burdensome for families, and I think there are many technological innovations that aim to do this, but I think it also is important to make sure the quality of the care that children receive remains high,” said lead author Kristin Ray, MD, in a statement. (Click for more...) Collaboration Drives an Exciting Development for In Silico Disease Modeling 4/9/2019 9:26:04 AM Partnerships between organizations with complementary goals and capabilities are increasingly proving to pave paths towards revolutionary advancements in life sciences. 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