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CVS installs medication disposal units in 28 pharmacies throughout Ohio 4/24/2018 11:35:31 PM CVS installs medication disposal units in 28 pharmacies throughout Ohio Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 CVS Health recently announced that it has installed medication-disposal units in 28 pharmacies throughout Ohio. The units are part of a plan to install the devices in 750 stores nationwide. CVS Health's Nicole Harrington said these pharmacy units are in addition to the more than 850 units donated to police departments nationwide, including 33 in Ohio. "CVS Health is very dedicated to preventing opioid abuse and misuse in the communities we serve," she said. "Safe-disposal units support that mission." All pharmacies face security requirements and collected medications must be disposed of through a reverse distributor that takes drugs back and incinerates them, said Cameron McNamee, director of policy and communications at the State of Ohio Board of Pharmacy. "Any opportunity to get medications out of the households that are no longer needed, particularly opioids, we think is crucial," McNamee said. (Click for more...) Medi-Cal commissioners say pharmacy reimbursement won't rise 4/24/2018 11:35:31 PM Medi-Cal commissioners say pharmacy reimbursement won't rise Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 The Ventura County Medi-Cal Managed Care Commission said Monday night they will not increase reimbursements to independent pharmacists, citing a consultant's findings that current rates are within industry norms. Pharmacists have noted low reimbursement rates are causing them to lose money and will soon push many of them out of business. But consultant Ken Dowell of Excelsior Solutions told commissioners the rates paid to independent pharmacists were similar to what is paid in similar plans elsewhere. "You're in market," he said. "I think you're right there." The commissioners govern the Gold Coast Health Plan, the publicly-funded organization that administers Medi-Cal for low-income Ventura County residents. They said the consultant's findings mean rate changes are currently not warranted. They pledged to make sure OptumRx, Gold Coast's PBM, is held accountable for the terms of its contract. (Click for more...) Southern IL pharmacist talks rising drug costs 4/24/2018 11:35:31 PM Southern IL pharmacist talks rising drug costs Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 In Illinois, the House of Representatives recently approved a measure that established the Illinois Generic Drug Pricing Fairness Act. House Bill 4900 provides that a manufacturer, or wholesale drug distributor, shall not engage in price gouging in the sale of an off-patent or generic drug. According to Ben Calcaterra, a pharmacist at Logan Primary Pharmacy and chairman of the Illinois Pharmacists Association, "This bill is not necessarily going to make a difference for them at the pharmacy counter, what it will do for them in the long run, prevent the drugs from being increased at a shorter rate," said Calcaterra. "However, if multiple claims are filed with the attorney general against these manufacturers, those legal fees will eventually be passed down." (Click for more...) Express Scripts targets new migraine drugs to change U.S. pricing dynamic 4/24/2018 11:35:30 PM Express Scripts targets new migraine drugs to change U.S. pricing dynamic Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 Express Scripts is pressing drugmakers to forego the usual strategy of setting a high U.S. list price, then lowering the cost for health plans through hefty rebates. The PBM is specifically calling on Amgen and other makers of new migraine medicines to try and fix the current pricing model. The shift could help Express Scripts and other PBMs bring prices down and deflect growing criticism of their role as "middlemen" in the drug supply chain. "If your expectation is that you are not going to actually get that high list price, then don't do that to patients who have high copays," says Chief Medical Officer Steve Miller, describing his message to Amgen and its rivals. "Let's be more balanced. Let's get back to where gross-to-net is not so different." Amgen's erenumab (Aimovig) is expected to be approved next month, followed by similar drugs from Teva Pharmaceutical Industries and Eli Lilly. The injected therapies interfere with the function of a molecule involved in the processes that kick off a migraine, such as dilation of blood vessels in the brain. Express Scripts is also pushing Amgen and its peers to refund two-thirds of the cost of a migraine drug if a patient stops treatment within 90 days because it did not work or caused major adverse events. (Click for more...) LabCorp at Walgreens expands into Florida 4/24/2018 11:35:30 PM LabCorp at Walgreens expands into Florida Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 Walgreens and LabCorp have expanded their LabCorp at Walgreens partnership into Florida. Ten new patient service centers will open within Walgreens stores in April and May, with four serving the Gainesville market and two each in Palm Beach County, Pasco County, and Orlando. These new locations join previously announced sites in Denver and North Carolina that opened last year. The LabCorp at Walgreens sites provide LabCorp patient services in a secure, comfortable environment for specimen collection. "We've had an outstanding experience with the six LabCorp at Walgreens locations that opened last year," said David King, LabCorp's chairman and CEO. "Patients and physicians have responded enthusiastically to having access to lab testing in a high-quality health care setting." Nimesh Jhaveri, vice president, health care services, Walgreens, also noted that "the LabCorp at Walgreens centers are a strong complement to our core pharmacy services and expertise, and another way in which we're working with partners to bring health care closer to our patients in the community." (Click for more...) Conflicts of interest of public speakers at meetings of the AADPAC 4/24/2018 11:35:30 PM Conflicts of interest of public speakers at meetings of the AADPAC Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 A team of Boston researchers investigated the characteristics and conflicts of interest of public speakers at meetings of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which advises FDA on drug products used in anesthesiology and pain management. For the study, the researchers identified AADPAC meetings related to the approval of drug products; reviewed meeting transcripts; and conducted web searches for evidence of financial associations between the sponsor and the speaker's organization, when speakers reported an organizational affiliation but disclosed no conflict of interest. From September 2009 through April 2017, there were 15 relevant AADPAC meetings, during which 91 individuals made 112 speaking appearances. Overall, the researchers determined that approximately one-quarter of the public speakers at AADPAC meetings have conflicts of interest, which were not disclosed about 20% of the time. Speakers with conflicts of interest were more likely to support drug approval vs. those who did not. "At meetings of all of its advisory committees, the FDA should require rather than simply encourage speakers to disclose their conflicts of interests," the researchers write. "During their deliberations, committee members can account for the conflicts of interest of public speakers only if they are aware of them." (Click for more...) Shaping pharmacy's 'story' amid health care evolution 4/24/2018 11:35:30 PM Shaping pharmacy's 'story' amid health care evolution Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 The National Association of Chain Drug Stores (NACDS) and its members plan to keep pace with any ongoing changes whether in the near or distant future, according to Steve Anderson, NACDS president and CEO, who spoke during the group's recent annual meeting. Alex Gourlay—NACDS chairman, co-COO of Walgreens Boots Alliance, and president Walgreens—said: "In health care, it has been about restructuring our industry to become more efficient in the marketplace, and in retail it really is about empowering the consumer—to see the choices and products available to them." Gourlay emphasized putting patients first by implementing changes in health care affordability and price transparency; fostering convenience, efficiency, and experience; and building trust by emphasizing community engagement and corporate social responsibility. "Redefining convenience has always been at the heart of the pharmacy model," he added. Gourlay also announced NACDS' commitment to shape the dialogue defining community pharmacy through the "2017 Chain Pharmacy Community Engagement Report," which was published on April 22. The report shares the many community engagement activities NACDS chain member companies make, including the $630 million in donations and 1.5 million hours in volunteer hours alone in 2017. (Click for more...) Many in middle age have arthritis--They just don't know it 4/24/2018 11:35:28 PM Many in middle age have arthritis--They just don't know it Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 While CDC estimates that 54 million Americans have been diagnosed with arthritis, new research suggests the population of people with chronic joint pain could actually be closer to 91 million. A large portion of those unaccounted for in the more conservative number may include middle-aged adults, who tend to schedule less-frequent doctor visits and also may ignore the symptoms of arthritis. While the numbers might be a source of contention, experts do agree that better care for the disease is paramount. Studies indicate that adults can significantly reduce their pain and prevent arthritis from limiting their activity through regular exercise and weight loss. With this in mind, CDC is bankrolling efforts to encourage doctors to guide patients toward proven programs; and its nonprofit Osteoarthritis Action Alliance this month is launching an online education campaign. "People worry that exercise is going to exacerbate their arthritis, when it's exactly the opposite," according to Alliance director Leigh Callahan. (Click for more...) HHS purchases anthrax antitoxin for Strategic National Stockpile 4/24/2018 11:35:28 PM HHS purchases anthrax antitoxin for Strategic National Stockpile Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 As part of the department's ongoing national preparedness efforts, HHS said Monday that it will buy obiltoxaximab (Anthim), an anthrax treatment, from manufacturer Elusys Therapeutics for $25.2 million. The Biomedical Advanced Research and Development Authority (BARDA), a component of HHS's Office of the Assistant Secretary for Preparedness and Response, provided funding under Project BioShield for continued manufacturing and purchase of obiltoxaximab. The treatment will be delivered to the Strategic National Stockpile. FDA approved obiltoxaximab in March 2016 for use in individuals suffering from inhalational anthrax. BARDA used Project BioShield to fund the first delivery of obiltoxaximab to the Strategic National Stockpile in 2016. "Protecting the American people from 21st century threats, such as anthrax, remains a high priority for the department," said Robert Kadlec, assistant secretary for preparedness and response. "This procurement under Project BioShield ensures we continue to have treatment options for people exposed to anthrax and increases the number of courses available in an emergency." (Click for more...) Effect of 5-day nitrofurantoin vs. single-dose fosfomycin on clinical resolution of uncomplicated lower UTI in women 4/24/2018 11:35:28 PM Effect of 5-day nitrofurantoin vs. single-dose fosfomycin on clinical resolution of uncomplicated lower UTI in women Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 A multinational trial compared outcomes with nitrofurantoin and with fosfomycin, both of which are recommended first-line therapies for lower urinary tract infection (UTI). In a sample of adult females presenting with uncomplicated UTI, 255 were randomized to treatment with 5-day oral nitrofurantoin, taken 3 times daily. The remaining 258 study participants were assigned to single-dose oral fosfomycin. The researchers collected urine cultures and performed clinical evaluations at 14 and 28 days following completion of therapy. At 28 days, full clinical resolution of symptoms and signs of UTI without prior failure was documented in 70% of the women who received nitrofurantoin and 58% of women who took fosfomycin. Microbiologic resolution, meanwhile, was achieved in 74% of the nitrofurantoin group and 63% of the fosfomycin group. With the between-group differences considered statistically meaningful, the trial results suggest that 5-day nitrofurantoin may be a more effective treatment for uncomplicated UTI than a single dose of fosfomycin. (Click for more...) FDA authorizes new use of test, first to identify the emerging pathogen Candida auris 4/24/2018 11:35:28 PM FDA authorizes new use of test, first to identify the emerging pathogen Candida auris Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 FDA has authorized the first test to identify Candida auris, a yeast that can cause serious infections in hospitalized patients and is often resistant to multiple antifungal drugs used to treat Candida infections. The agency on April 20 permitted marketing for a new use of the Bruker MALDI Biotyper CA system (Bruker Daltonik GmbH) for the identification of C. auris, adding to the system's already approved uses for the identification of more than 300 species or species groups, for 424 clinically relevant bacteria and yeast species. The system uses matrix-assisted laser desorption/ionization (MALDI-TOF) mass spectrometry in combination with a reference organism database. Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health, said: "The FDA has confidence in this technology and recognizes the need to rapidly address outbreaks both for C. auris and for other pathogenic microorganisms to help protect Americans through the recognition and identification of emerging infectious pathogens." FDA also plans to propose to exempt certain mass spectrometry microorganism identification system processes from an additional premarket review after a system process receives a first-time FDA marketing authorization. (Click for more...) DEA plan to stem supply of prescription drugs draws skepticism 4/24/2018 11:35:26 PM DEA plan to stem supply of prescription drugs draws skepticism Mon, 04/23/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 23:35 A new DEA proposal aims to empower the agency to tighten overall quotas and individual quotas issued to drug manufacturers if it suspects supplies are being diverted for misuse. Capitol Hill aides and multiple former federal drug policy officials say the rule's effectiveness will depend on how often DEA chooses to enforce it. Others express skepticism that the rule will lead to crackdowns on individual drug manufacturers. "This doesn't get us anywhere, because in the end you’re opening the door for a lot of challenges to your quota process," says Joe Rannazzisi, the former head of DEA's Office of Diversion Control. Experts say it could be difficult for DEA to adjust individual quotas based on evidence of drug diversion. While states often have evidence about oversupply in certain communities or even from specific pharmacies, Rannazzisi says it will be difficult to pinpoint individual manufacturers responsible at the top of the supply chain. Attempting to do so, Rannazzisi says, could result in shortages, even for patients with legitimate medical need. (Click for more...) Celebrate pharmacists making a global impact during World Immunization Week 4/24/2018 9:00:30 AM Celebrate pharmacists making a global impact during World Immunization Week Tue, 04/24/2018 - 09:05 ehaberkorn@aph… Tue, 04/24/2018 - 09:00 Pharmacists in the United States have established themselves as valuable members of the immunization neighborhood, and pharmacists across the world are following their lead. Still, as of 2016, global efforts to enhance uptake of immunization have stalled. (Click for more...) Pharmacists joining forces to fight opioid epidemic 4/24/2018 8:05:01 AM Pharmacists joining forces to fight opioid epidemic Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 The Ohio Pharmacists Association (OPA) announced at its annual conference on Friday the creation of a task force to promote safe medication practices that prevent powerful opioids from getting into the wrong hands. The OPA is also encouraging more local task forces, which many cities and counties have in place to combat the high number of opioid overdoses in their communities to include a local pharmacist. "Often we are left out," said Ernest Boyd, executive director of OPA. "We have the most training in the safe use of drugs." Boyd noted that pharmacists have been on the front lines of the opioid crisis, advising patients on new prescribing guidelines for acute or short-term pain, and explaining why the amount of pain medication they receive may now be limited. They also are able to explore alternative pain management options with patients, including OTC options. In addition, pharmacists are working to educate patients on proper use and the importance of proper disposal of opioids. OPA is working with Generation Rx, a statewide education program for young people about proper medication use. (Click for more...) Re-emergence of yaws after single mass azithromycin treatment followed by targeted treatment 4/24/2018 8:05:01 AM Re-emergence of yaws after single mass azithromycin treatment followed by targeted treatment Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 The World Health Organization's (WHO) strategy for eradicating the pediatric infection known as yaws has already demonstrated short-term efficacy, leaving researchers to investigate its utility over the long run. They chose Papua New Guinea, where yaws was endemic, as their testing ground. The study population included about 16,000 people living on Lihir Island. WHO's protocol calls for a single round of mass azithromycin therapy followed by targeted treatment programs as a way to eliminate the condition, which causes disfiguring ulcers. With approximately 13,500 individuals submitting to the mass treatment, the longitudinal study achieved population coverage of nearly 84%. Based on blanket testing for the condition every 6 months over a period of 3.5 years, the strategy did significantly reduce yaws over the first 2 years; but the infection began to resurface after that. The WHO strategy, therefore, did not accomplish long-term elimination of yaws in this highly endemic community. Rather, the infection re-emerged in children who were absent during initial mass treatment, signaling the potential need for repeat mass treatments. (Click for more...) Recommendations of the ACIP for use of a hepatitis B vaccine with a novel adjuvant 4/24/2018 8:05:01 AM Recommendations of the ACIP for use of a hepatitis B vaccine with a novel adjuvant Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 Hepatitis B vaccination (HepB) is key to the prevention of the virus and associated complications. While most existing vaccines use an aluminum adjuvant, CDC's Advisory Committee on Immunization Practices (ACIP) this February recommended a yeast-derived formulation prepared with a novel immunostimulatory sequence adjuvant. FDA approved the HepB-CpG vaccine (Dynavax Technologies) last November—making it the fifth inactivated HepB vaccine sanctioned in the United States—and reached the decision to endorse it after a systematic review of the evidence. The literature included four randomized controlled trials evaluating prevention of HBV infection and six assessing adverse events in adult patients. Outcomes with HepB-CpG were compared with outcomes from Engerix-B (GlaxoSmithKline Biologicals). Based on the results, ACIP recommends HepB-CpG for adults aged 18 years and older. The vaccine is to be administered in 2 doses, with a 1-month buffer in between; and both doses should consist of HepB-CpG, rather than interchanging brands. Moreover, for recipients who took a single earlier dose of vaccine from another manufacturer, the 2-dose HepB-CpG regimen is still effective when administered at least 4 weeks apart. ACIP does not note any special considerations for pregnant women. However, serologic testing is advised 1–2 months after the last dose in patients who are immunocompromised, have HIV, health care workers, and intimate partners of individuals who test positive for HepB surface antigens. Results will gauge the response to vaccination as well as the need for revaccination. (Click for more...) CDC warns against eating romaine lettuce as E. coli sickens dozens 4/24/2018 8:05:01 AM CDC warns against eating romaine lettuce as E. coli sickens dozens Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 Amid a widening outbreak of E. coli linked to produce grown in Yuma, AZ, CDC https://www.cdc.gov/ecoli/2018/o157h7-04-18/index.html target="_blank">warned on Friday that consumers should avoid all types of romaine lettuce from that area. Previously, the agency had advised consumers to avoid chopped romaine, salads, and salad mixes that contained the lettuce; however, CDC now advises avoiding all romaine purchased from stores, including whole heads and hearts of romaine. "Unless the source of the product is known, consumers anywhere in the United States who have any store-bought romaine lettuce at home should not eat it and should throw it away, even if some of it was eaten and no one has gotten sick," CDC said. The expanded warning was prompted by new illnesses reported at an Alaskan correctional facility. Most of the lettuce sold commercially in the United States during the winter months is grown in Yuma; however, product labels often do not list where the lettuce was grown, according to CDC. Health officials have not yet pinpointed a common source of the contaminated lettuce. CDC last week launched an investigation into a nationwide outbreak of E. coli 0157:H7 linked to romaine lettuce that has affected 53 people across in states, with 31 hospitalizations. (Click for more...) Pharmacists warn against potentially lethal counterfeit drugs laced with fentanyl 4/24/2018 8:05:01 AM Pharmacists warn against potentially lethal counterfeit drugs laced with fentanyl Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 Ernest Boyd, the executive director of the Ohio Pharmacists Association, is warning people that counterfeit drugs are being laced with lethal doses of the opioid fentanyl in Ohio and across the United States. Boyd cautions people against taking any medications that are not prescribed by a doctor and obtained from a legitimate pharmacy. "It's insane this is going on, but the tablets look like what we sell in the pharmacies," says Boyd. The Partnership for Safe Medicines, in a publication released this month, says counterfeit drugs have been found in 43 states, with people dying from them in 22. Boyd says some drugs are ordered by unsuspecting people from Internet sites that appear to be legitimate pharmacies. He notes legitimate online pharmacies will have a ".pharmacy" domain and a "Verified Internet Pharmacy Practice Sites" (VIPPS) seal from the National Association of Boards of Pharmacy. (Click for more...) CVS Pharmacy offering hepatitis A vaccine to Kentuckians 4/24/2018 8:05:01 AM CVS Pharmacy offering hepatitis A vaccine to Kentuckians Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 With more than 300 hepatitis A cases confirmed in Kentucky since 2017, CVS Pharmacy announced that all of its pharmacy locations in the state have the hepatitis A vaccine available for individuals who have not yet been vaccinated against the disease. CVS Pharmacy stores located along the Kentucky border—such as those in Ironton, OH, and Kenova, WV—have the hepatitis A vaccine in stock as well, the company said. Most recently, cases of hepatitis A have been confirmed in Ashland, Berea, and Louisville. CVS pharmacists can administer the hepatitis A vaccine to individuals aged 18 years and older. The vaccine is administered as one primary dose and then a booster dose, usually given 6 months later. CVS Pharmacy has 70 locations in Kentucky, including 9 CVS Pharmacy locations in Target stores. (Click for more...) As opioid prescriptions fall, prescriptions for drugs to treat addiction rise 4/24/2018 8:05:01 AM As opioid prescriptions fall, prescriptions for drugs to treat addiction rise Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 The number of new prescriptions for drugs that treat opioid addiction nearly doubled over the course of 2017, from 42,000 per month to 82,000, according to the IQVIA Institute for Human Data Science. The trend comes amid a campaign by the Trump administration and many states to expand access to these medications in an attempt to combat the nation's opioid epidemic. The increase also accompanies a decline in the number of prescriptions for opioid analgesics, which have been falling since 2011, according to the IQVIA report. However, it also prompts questions about whether some pain patients are now being undertreated, and whether restricted prescribing has contributed to the hike in overdose deaths from heroin and fentanyl. One doctor also warned that there is no way of knowing from the data whether the prescriptions came with behavioral therapy and other support, which most experts recommend for people taking addiction medication. Meanwhile, the federal government predicts that only about 20% of the approximately 2.6 million people believed to suffer from addiction are receiving some type of treatment, and only about one-third of those are getting buprenorphine, naltrexone, or methadone. (Click for more...) Pharmacies continue to reject prescriptions due to noncompliant forms 4/24/2018 8:05:01 AM Pharmacies continue to reject prescriptions due to noncompliant forms Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 The California Dental Association (CDA) says dentists continue to report that pharmacies are rejecting the controlled substances prescriptions they write for patients. CDA reported last November that pharmacies were rejecting prescriptions that were out of date or missing required elements. Most of the rejected prescriptions have been for controlled substances or schedule II-V drugs. At a December meeting, the California Board of Pharmacy's Enforcement and Compounding Committee heard public comments in which several recommendations were made. Among them was a request for a standardized prescription template to ensure consistent compliance. The committee agreed to "work with the [California] Department of Justice to ensure that prescribers are receiving compliant forms." The pharmacy committee noted that two major required elements are frequently missing: the checkoff box to indicate the number of refills and the watermark. Teresa Pichay, CDA's regulatory compliance analyst, says noncompliant tamper-resistant forms can still be used for non-narcotic prescriptions such as antibiotics. She notes, "Learn the required elements on these prescription forms. This is the first step to ensuring your patients are not refused prescribed medication at the pharmacy." (Click for more...) Naloxone now available at Kmart Pharmacy locations nationwide 4/24/2018 8:05:01 AM Naloxone now available at Kmart Pharmacy locations nationwide Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 Kmart Pharmacy announced this week that naloxone is now available without an individual prescription at its pharmacies nationwide. In states where it is permitted by law, Kmart pharmacists can now dispense the opioid overdose-reversal medication to patients without an individual prescription. "We agree with the U.S. Surgeon General's call to make naloxone more widely available," said William Linnane, president of Kmart Pharmacy. "Every day, more than 115 Americans die after overdosing on opioids. The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare." The company noted that its pharmacists are trained and equipped with resources to recommend, dispense, and educate caregivers, family, and friends about naloxone. (Click for more...) Genoa hits milestone as 400th store debuts 4/24/2018 8:05:01 AM Genoa hits milestone as 400th store debuts Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 Tukwila, WA.-based Genoa Healthcare, a behavioral health pharmacy operator, has opened its 400th location in Renton, WA. In March, Genoa hosted a grand opening of its newest pharmacy at Comprehensive Life Resources, a nonprofit behavioral health center. Genoa's revenue increased 30% in the past year while its patient population rose by 26% and its prescription volume increased by 24%. The new location gives Genoa a total of 17 pharmacies in Washington state. Its 400 pharmacies overall serve more than 650,000 patients across 45 states and Washington, DC. The company also operates the Genoa Telepyschiatry service, which reaches more than 2,500 patients weekly and serves 35 states. (Click for more...) FDA takes new steps to advance the development of innovative products for treating OUD 4/24/2018 8:05:01 AM FDA takes new steps to advance the development of innovative products for treating OUD Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 FDA announced on Friday the latest action to encourage and support the development of treatment options for individuals with opioid use disorder (OUD). The agency released a https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma…; target="_blank">draft guidance aimed at helping industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. The guidance explains FDA's current thinking about drug development and clinical trial design issues relevant to the study of sustained-release "depot" buprenorphine products. "We know medication-assisted treatment is effective in treating addiction, and we at the Department of Health and Human Services are using every avenue we have to boost access to it," said HHS Secretary Alex Azar. "FDA Commissioner Scott Gottlieb has made advancing medication-assisted treatment a priority at FDA in particular, and we believe this new guidance can help accelerate the pathway for developing new drugs and new formulations of existing drugs." The new draft guidance highlights ways drug manufacturers can more efficiently explore innovations in depot buprenorphine products. The agency noted that a proposed depot buprenorphine product that is similar to an approved product, including in exposure levels to the drug, may have characteristics that make it ineligible to be a generic drug approved under an abbreviated new drug application. The guidance also describes the types of studies FDA recommends for depot buprenorphine products that are similar to an approved depot product, as well as depot buprenorphine products with novel features relative to approved depot products. (Click for more...) PhRMA spends record amount on lobbying amid drug pricing fights 4/24/2018 8:05:01 AM PhRMA spends record amount on lobbying amid drug pricing fights Sun, 04/22/2018 - 20:00 cbaker_admin Tue, 04/24/2018 - 08:05 The Pharmaceutical Research and Manufacturers of America (PhRMA) spent nearly $10 million on lobbying efforts between January 1 and March 31, according to federal filings, breaking its own record for the most spent in a single quarter. PhRMA spent the first quarter of this year battling the CREATES Act, a bipartisan bill intended to increase competition among generic and branded drug manufacturers. Congressional supporters of the bill intended to include it in the spending bill passed in February, but it did not make it in. The drug industry and PhRMA argued the legislation would have created "frivolous litigation." Drug companies have increased lobbying efforts as the industry faces regulatory uncertainty. From 2016 to 2017, PhRMA increased its lobbying spending by 30%. (Click for more...) APhA honors 2018 Immunization Champions 4/23/2018 9:54:14 AM APhA honors 2018 Immunization Champions Mon, 04/23/2018 - 11:15 ehaberkorn@aph… Mon, 04/23/2018 - 09:54 The American Pharmacists Association (APhA) presented the 2018 Immunization Champion Awards on March 18, 2018 at the 2018 Annual Meeting & Exposition in Nashville. (Click for more...) Drug overdoses tied to 24-fold rise in organ transplants 4/21/2018 5:05:01 AM Drug overdoses tied to 24-fold rise in organ transplants Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 An increase in the number of drug overdose deaths related to the opioid epidemic has contributed to a growing number of organ transplants nationwide, according to new research in the Annals of Internal Medicine. The number of overdose-death donors increased from 1.1% of all donors in 2000 to 13.4% in 2017. The study involved data from the Scientific Registry of Transplant Recipients between January 2000 and September 2017. In all, 7,313 overdose-death donors were identified who had at least one organ recovered during the study period, for a total of 19,897 transplants. "Patients who received transplants from these donors had excellent outcomes; patient survival and organ function were similar to cases when donors died due to trauma and similar or better than cases when the donor died due to medical causes of death, like heart attack or stroke," said study leader Christine Durand, MD, assistant professor of medicine and oncology at Johns Hopkins University. However, the researchers also identified a number of organs from overdose-death donors that were recovered but then discarded. "This discard was primarily related to an increasing prevalence of hepatitis C infection among overdose-death donors and increased infectious risk," Durand explained. She points out, "Patients and their transplant teams have to weigh the small risk of an infection like hepatitis C—for which we now have a cure—against the risk of dying on the wait list." (Click for more...) Federal judge enters consent decree against Cantrell Drug Company 4/21/2018 5:05:01 AM Federal judge enters consent decree against Cantrell Drug Company Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 On Thursday, a federal judge in Arkansas entered a consent decree of permanent injunction against Cantrell Drug Company of Little Rock and the company's CEO and co-owner, James L. McCarley, Jr. The consent decree bars Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with the federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements. "As a public health agency, the FDA is committed to fully implementing the Drug Quality and Security Act for compounded drugs set forth by Congress that helps ensure compounded drugs are made under appropriate production standards," said FDA Commissioner Scott Gottlieb, MD. "We'll continue to take action against compounders who produce drugs under substandard conditions and put the health of patients at risk." The complaint filed with the consent decree claims that Cantrell manufactured and distributed purportedly sterile drug products that were adulterated under the FD&C Act because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. The complaint was filed by the U.S. Department of Justice on behalf of FDA. (Click for more...) FDA panel backs proposed epilepsy drug derived from cannabis 4/21/2018 5:05:01 AM FDA panel backs proposed epilepsy drug derived from cannabis Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 An FDA advisory panel on Thursday unanimously recommended approval of a prescription cannabidiol medication for the treatment of rare forms of epilepsy. With a vote of 13-0, the panel said the risk-benefit profile was favorable for cannabidiol (Epidiolex—GW Pharmaceuticals) to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. According to the drug's manufacturer, the medicine is made from a proprietary strain of cannabis that maximizes a therapeutic component while minimizing components that produce euphoria. Company-sponsored clinical trials found that cannabidiol reduced the frequency of patients' seizures. One study of 120 children and young adults with Dravet syndrome found that cannabidiol lowered the median frequency of convulsive seizures from 12.4 a month before treatment to 5.9 a month, while patients who received a placebo saw only minimal decreases. While the drug is associated with some adverse events—such as gastrointestinal problems and abnormal liver-function test results—FDA officials said Thursday they thought the risks were manageable if cautionary language is included on the drug's prescribing label, and if FDA monitors liver risk after the drug is put on the market. Agency officials also noted the drug does not appear to have abuse potential. FDA is expected to decide by the end of June whether to approve the drug for sale. (Click for more...) Once-daily single-inhaler triple vs. dual therapy in patients with COPD 4/21/2018 5:05:01 AM Once-daily single-inhaler triple vs. dual therapy in patients with COPD Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 Researchers involved in the IMPACT clinical trial compared outcomes in COPD patients after 1 year of treatment with either triple therapy or standard dual therapy, each administered through a single inhaler once daily. The study population included 4,151 participants who received triple therapy with the inhaled glucocorticoid fluticasone furoate plus the long-acting muscarinic antagonist umeclidinium and the long-acting B2 antagonist vilanterol. Another 6,204 participants were randomized to dual therapy with either fluticasone furoate–vilanterol or umeclidinium–vilanterol. Investigators specified the primary outcome as the incidence of moderate or severe COPD exacerbations during the treatment period. The rate was 0.91 per year for the triple therapy group vs. 1.07 per year for the fluticasone furoate–vilanterol group and 1.21 per year for the umeclidinium–vilanterol group. The annual rate of severe exacerbations requiring hospitalization was 0.13 among patients assigned to triple therapy, 0.15 among those assigned to fluticasone furoate–vilanterol, and 0.19 among those assigned to umeclidinium–vilanterol. While triple therapy reduced the rate of moderate and severe exacerbations in COPD patients, it was also associated with a greater risk for pneumonia compared with umeclidinium-vilanterol dual therapy. (Click for more...) Kentucky recommends hepatitis A vaccination for individuals in counties affected by outbreak 4/21/2018 5:05:01 AM Kentucky recommends hepatitis A vaccination for individuals in counties affected by outbreak Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 Amid an ongoing outbreak of hepatitis A in the state, Kentucky health officials are recommending vaccination for everyone living in the six counties affected. More than 300 cases have been reported in the outbreak, which has Jefferson, Bulitt, Hardin, Greenup, Carter, and Boyd counties. Of the 311 total cases, 214 have been reported in the Jefferson County/Louisville area. One death has been reported. "Hepatitis A is a vaccine-preventable illness. [The Department for Public Health] recommends all children, ages 1 year through 18, receive the hepatitis A vaccine as well as adults who want to protect themselves from an acute hepatitis A infection," said Jeffrey Howard, MD, acting DPH commissioner. "In these counties with local transmission of the hepatitis A virus, we recommend everyone be vaccinated per guidelines to help stop this outbreak." (Click for more...) Dabigatran antidote idarucizumab picks up full FDA approval 4/21/2018 5:05:01 AM Dabigatran antidote idarucizumab picks up full FDA approval Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 FDA has given full approval to idarucizumab (Praxbind—Boehringer Ingelheim) to reverse the anticoagulant effect of dabigatran (Pradaxa—Boehringer Ingelheim) in the event of urgent surgery or life-threatening or uncontrolled bleeding. In October 2015, FDA granted accelerated approval to the monoclonal antibody fragment, with continued approval contingent upon the results of the recently completed RE-VERSE AD trial. The results of the Phase III trial were "overwhelmingly convincing," showing that two bolus doses of idarucizumab achieved full reversal of dabigatran within about 10 minutes in most cases. No adverse safety signals were observed, and the most frequently reported adverse events in at least 5% of patients were constipation (7%) and nausea (5%). (Click for more...) USPSTF: Exercise best for preventing falls 4/21/2018 5:05:01 AM USPSTF: Exercise best for preventing falls Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 Updated recommendations from the U.S. Preventive Services Task Force (USPSTF) state that exercise is the most effective for preventing falls in at-risk older adults, while vitamin D is not effective for this purpose (D statement). The USPSTF also did not support use of vitamin D for preventing fractures in adults, recommending against supplementation with up to 400 IU/day in most post-menopausal women (D statement) and noting there was insufficient evidence to assess the benefit-risk balance with higher doses. The task force reached the same conclusions 5 years ago. The group of USPSTF researchers noted that multifactorial interventions for fall prevention tailored to individual patients—such as exercise, cognitive behavioral therapy, or environmental modification—are moderately effective. According to a systematic review of 62 randomized clinical trials, exercise significantly lowered the risk of experiencing a fall and injurious falls. Multifactorial interventions led to a substantial reduction in fall risk, though not for fall-related morbidities, the task force reported in the Journal of the American Medical Association. For vitamin D supplements, meanwhile, the evidence was mixed, with most trials reporting nonsignificant results. "The USPSTF recommends against vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older (D recommendation). These recommendations apply to community-dwelling adults who are not known to have osteoporosis or vitamin D deficiency," the task force said. (Click for more...) CVS Pharmacy launches first campaign featuring unaltered beauty imagery 4/21/2018 5:05:01 AM CVS Pharmacy launches first campaign featuring unaltered beauty imagery Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 CVS Pharmacy has unveiled "Beauty in Real Life," a new advertising campaign demonstrating the company's commitment to authenticity. The ad campaign, first announced in January, aims to create new standards for beauty imagery in order to highlight a more realistic image of beauty for CVS customers. This is the first campaign to adapt new standards for post-production photo alterations and will include the first images with the "CVS Beauty Mark," a watermark created to highlight images that have not been materially altered. According to the company, the Beauty in Real Life campaign shows real women representing broad diversity and showing beauty on their own terms within "real-life" beauty moments. "There's been a shift in what consumers want to see when it comes to beauty. They are asking for more transparency and authenticity, and that's what Beauty in Real Life is all about," said Norman de Greve, Senior Vice President and Chief Marketing Officer, CVS Health. (Click for more...) Naloxone available at Rite Aid pharmacies in 19 states 4/21/2018 5:05:01 AM Naloxone available at Rite Aid pharmacies in 19 states Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 Naloxone is available at each of the more than 2,500 Rite Aid pharmacies in the United States and can be dispensed without a prescription, subject to state regulations, the company said Thursday. "The opioid epidemic has reached epic proportions and it is an issue that demands not only our attention but also our continued action to help reduce the rise in opioid deaths," said Jocelyn Konrad, Rite Aid executive vice president of pharmacy. "For the past 2 years, we've worked with state and federal lawmakers to increase access to this life-saving medication." Rite Aid pharmacies in the following states stock naloxone: California, Colorado, Connecticut, Delaware, Idaho, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Vermont, Virginia, and Washington. Additional steps the company has taken to address drug abuse and misuse include ongoing education and training of Rite Aid pharmacists, participation in prescription drug monitoring programs, increased patient education efforts, and support of the CDC guideline for prescribing opioids. (Click for more...) AMA sees progress in declining opioid prescriptions 4/21/2018 5:05:01 AM AMA sees progress in declining opioid prescriptions Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 Health care providers are increasingly judicious when prescribing opioids, the American Medical Association (AMA) said Thursday, citing a 22% decline in opioid prescriptions nationally between 2013 and 2017. "It is notable that every state has experienced a decrease, but this is tempered by the fact that deaths related to heroin and illicit fentanyl are increasing at a staggering rate, and deaths related to prescription opioids also continue to rise," said Patrice A. Harris, MD, MA, chair of the AMA Opioid Task Force. Simply reducing prescription opioid supplies will not end the opioid crisis, Harris said, calling for "well-designed initiatives that bring together public and private insurers, policymakers, public health infrastructure, and communities with the shared goal to improve access and coverage for comprehensive pain management and treatment for substance use disorders." New treatment starts for medication-assisted treatment for patients with opioid use disorders nearly doubled from December 2015 to December 2017, according to IQVIA. This is a sign of progress, Harris said, adding that "we all must take care that policies and practices don't restrict access to one alternative for pain relief without increasing access to comprehensive, multidisciplinary pain care, including non-opioid-based options." (Click for more...) Fred's looks to unload specialty pharmacy business 4/21/2018 5:05:01 AM Fred's looks to unload specialty pharmacy business Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 A form filed with the Securities and Exchange Commission on April 18 suggests that Memphis-based Fred's wants to sell its specialty pharmacy business. The company said in the filing that its board of directors has approved the plan to sell the specialty pharmacy business, which includes three specialty-only locations. Fred's has rescheduled its earnings report for May 4. The company had been set to acquire enough divested stores to make it the third-largest drug chain in the nation, but the recently completed Walgreens acquisition of 1,932 Rite Aid stores did not necessitate a divestment. As a result, in the first 8 months of its fiscal year ended October 28, 2017, the company reported a $37.3 million contribution to its $117.8 million net loss from costs associated with bank fees, financing termination fees, and professional and legal and advisory fees associated with the Rite Aid store acquisition. The company has undertaken efforts to reduce costs, included reducing its workforce and excess inventory that it leveraged into a clearance sale to drive foot traffic. Fred's CEO Mike Bloom, as part of the company's December 2017 third-quarter earnings call, told analysts and investors that the company was in the midst of "a review of alternatives for the noncore assets of real estate and the specialty pharmacy business." (Click for more...) HHS provides states second installment of grant awards to combat opioid crisis 4/21/2018 5:05:01 AM HHS provides states second installment of grant awards to combat opioid crisis Thu, 04/19/2018 - 20:00 cbaker_admin Sat, 04/21/2018 - 05:05 HHS released on Wednesday the second installment of funding to help states and territories continue their fight against the opioid crisis. In all, $485 million will be provided to 50 states, 4 U.S. territories, and the free associated states of Palau and Micronesia. HHS Secretary Alex Azar noted, "These funds will help support evidence-based efforts at the state level to prevent misuse of opioids in the first place, expand access to effective treatment options for people in need, and support recovery for those who have prevailed." The Opioid State Targeted Response grants, created by the 21st Century Cures Act, are administered by the Substance Abuse and Mental Health Services Administration. Recipients have used first-year funding to implement effective medication-assisted treatment, promote the use of naloxone and key prevention strategies, and build sustainable systems of recovery support services nationwide. (Click for more...) Up to 80% of Medicaid patients may be using insulin glargine past recommended discard date 4/20/2018 12:34:45 PM Up to 80% of Medicaid patients may be using insulin glargine past recommended discard date Fri, 04/20/2018 - 12:38 ehaberkorn@aph… Fri, 04/20/2018 - 12:34 Many Medicaid patients who use insulin glargine multiple-dose vials may be using it beyond the 28-day limit on punctured bottles, possibly leading to questionable product stability and sterility, according to research published online in the Journal of the American Pharmacists Association. (Click for more...) U.S. senators put pressure on Juul, FDA to tighten marketing regulations 4/20/2018 4:05:01 AM U.S. senators put pressure on Juul, FDA to tighten marketing regulations Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 Nearly a dozen Democratic U.S. senators are calling on the top-selling e-cigarette maker and FDA to tighten the marketing of the devices. The senators are urging FDA "to take immediate steps to ban kid-friendly candy and fruit flavorings that are used with e-cigarettes and cigars." During testimony before Congress this week, FDA Commissioner Scott Gottlieb, MD, indicated the agency is considering addressing soon how Juul is marketed. Juul is sold in the form of a pen or USB flash drive that is easy to use and hide. In a separate letter the Kevin Burns, CEO of Juul Labs Inc., the senators questioned how the product is marketed to children and teens and asked what ingredients are in the flavorings that accompany these products. The senators asked Juul to take self-imposed steps to limit youth use of their product. "Your company's popular vaping device and its accompanying flavored nicotine cartridges are undermining our nation's efforts to reduce tobacco use among youth and putting an entire new generation of children at risk of nicotine addiction and other health consequences," the senators said in their letter to Burns. In a statement, Burns said the company "takes this matter very seriously," and he said they are finalizing a plan for new actions and initiatives that will be introduced soon. (Click for more...) NIH abruptly changes course on industry opioids partnership after ethics flags raised 4/20/2018 4:05:01 AM NIH abruptly changes course on industry opioids partnership after ethics flags raised Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 In an abrupt shift, NIH announced late last week that it will not accept funds from drug makers as part of a planned opioids research partnership worth roughly $400 million. Citing recommendations issued earlier this month by an advisory panel, NIH Director Francis Collins said the agency will exclusively use taxpayer money to fund a comprehensive research initiative on pain and substance use disorder treatment. "I fully embrace [the] recommendation that NIH should vigorously address the national opioid crisis with government funds and decline cash contributions through partnerships from the private sector," Collins said in a statement. Instead of accepting cash from drug companies interested in teaming up, Collins said the NIH would lean on industry only for help in setting up a clinical trial network, establishing common biomarkers for drug development, and sharing data. The move was a major shift for Collins, who has publicly expressed excitement about the partnership, specifically pointing to the prospect of drug companies chipping in funds to leverage agency dollars. NIH has reportedly become wary of the perception that the private sector wields too much influence over the direction of taxpayer-funded research. (Click for more...) DEA to share prescription drug data with 50 attorneys general, crack down on drugmakers 4/20/2018 4:05:01 AM DEA to share prescription drug data with 50 attorneys general, crack down on drugmakers Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 DEA has reached an agreement with 50 attorneys general to share prescription drug data with one another to support ongoing investigations. The agency will provide attorneys general in 48 states, the District of Columbia, and Puerto Rico with data from its Automation of Reports and Consolidated Orders System, which collects 80 million prescription drug transactions from manufacturers and distributors each year. In return, states will provide the federal agency with their own data from prescription drug monitoring programs. Delaware and Arkansas are the only two states not participating in the data-sharing agreement. The agreement comes months after President Trump's opioid commission announced its support for the Prescription Drug Monitoring Program Act, which would provide funding for a DOJ-led data sharing hub. U.S. Attorney General Jeff Sessions said the data-sharing pact will "make both DEA and our state partners more effective at finding evidence of crime." Enforcement has been a focal point in the Trump administration's approach to the opioid crisis. Last year, the Department of Justice created the Opioid Fraud and Abuse Detection Unit to focus on using data to track down individuals illegally distributing opioids. (Click for more...) Cigna-Express Scripts deal to face Justice Department review 4/20/2018 4:05:01 AM Cigna-Express Scripts deal to face Justice Department review Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 The U.S. Department of Justice plans to review Cigna's planned purchase of Express Scripts Holding, Cigna said Wednesday. The health insurer agreed in March to acquire Express Scripts, a PBM, for $54 billion. The company hopes the combination can lower costs and improve benefits for Americans by simplifying the health care supply chain. In a statement, Cigna said it is "optimistic in our ability to obtain regulatory approval." (Click for more...) Bernie Sanders introduces bill to impose jail time for execs behind opioid crisis 4/20/2018 4:05:01 AM Bernie Sanders introduces bill to impose jail time for execs behind opioid crisis Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 Sen. Bernie Sanders (I-VT) is proposing a bill to impose jail time for pharmaceutical executives whose companies engage in manipulative practices when marketing opioids. If an executive's company is found to have illegally contributed to the opioid crisis, he or she would face a 10-year minimum prison sentence and fines equal to an executive's compensation package. The measure would also impose an additional fine of $7.8 billion on those companies, reflecting one-tenth the annual cost of the crisis, per a 2016 estimate. The bill contains potential mechanisms by which HHS could demonstrate liability, such as mandating written justifications for opioid orders that seem medically unreasonable. Meanwhile, an opioid reimbursement fund, to be administered by HHS, would collect fines levied under the new law and distribute them to other federal departments. The bill would also prevent companies from directly marketing opioid products without adequate warning of their addictive properties. (Click for more...) After signs that cancer patients could take less of an expensive drug, its maker tripled the price 4/20/2018 4:05:01 AM After signs that cancer patients could take less of an expensive drug, its maker tripled the price Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 A group of cancer doctors focused on bringing down the cost of treatments by testing whether lower doses are effective thought they had found a prime candidate in the blood cancer drug ibrutinib (Imbruvica—Pharmacyclics) that typically costs $148,000 a year. The science behind the drug suggested that it could work at lower doses, and early clinical evidence indicated that patients with chronic lymphocytic leukemia might do just as well on one or two tablets a day after completing an initial round of treatment at three tablets per day. The researchers at the Value in Cancer Care Consortium set out to test whether the lower dose was just as effective. Then they learned of a new pricing strategy by Janssen and Pharmacyclics, the companies that sell the drug through a partnership. Within the next 3 months, the companies will stop making the original 140-milligram capsule. They will instead offer tablets in four strengths—each of which has the same flat price of about $400, or triple the original cost of the drug. Janssen and Pharmacyclics said the companies began to develop the new single-tablet dosing regimen in 2015 "as a new innovation to provide patients with a convenient one tablet, once-a-day dosing regimen and improved packaging, with the intent to improve adherence to this important therapy." They called the studies on lower dosing "highly exploratory in nature." (Click for more...) Gene therapy in patients with transfusion-dependent beta-thalassemia 4/20/2018 4:05:01 AM Gene therapy in patients with transfusion-dependent beta-thalassemia Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 Interim results of a new study show that gene therapy reduced or eliminated the need for long-term red-cell transfusions in nearly two dozen patients with severe beta-thalassemia without serious adverse events related to the drug product. The study involved two Phase I–II trials in which researchers obtained mobilized autologous CD34+ cells from 22 patients with transfusion-dependent beta-thalassemia and transduced the cells ex vivo with LentiGlobin BB305 vector, which encodes adult hemoglobin (HbA) with a T87Q amino acid substitution (HbAT87Q). The cells were reinfused after the patients had undergone myeloablative busulfan conditioning. At a median of 26 months after infusion of the gene-modified cells, 12 of the 13 patients who had a non–beta0/beta0 genotype had stopped receiving red-cell transfusions. In 9 patients with a beta0/beta0 genotype or two copies of the IVS1-110 mutation, the median annualized transfusion volume was reduced by nearly 75%, and red-cell transfusions were stopped in 3 patients. No serious adverse events related to the drug product were detected, and there were no significant unexpected safety issues, the researchers found. They report "that gene therapy with LentiGlobin drug product succeeded in overcoming a principal limitation of allogeneic hematopoietic-cell transplantation, which is a lack of a histocompatible donor. The safety profile after infusion was consistent with that associated with myeloablative conditioning with single-agent busulfan." (Click for more...) Study shows post-operative medication can prolong and cause chronic pain 4/20/2018 4:05:01 AM Study shows post-operative medication can prolong and cause chronic pain Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 Research out of the University of Colorado, Boulder suggests that postoperative opioid use actually makes pain last longer. The finding was observed in male rats that were subjected to exploratory abdominal surgery, then either weaned off or abruptly withdrawn from morphine relief in the following days. In other cases, animal subjects that received a saline solution were compared with those that received morphine. According to the investigators, rats administered morphine suffered postoperative pain for more than 3 weeks longer than controls. The longer they received the opioid, with or without gradual tapering, the longer the pain persisted. Although the researchers concede their findings may not apply to humans in exactly the same way, they say the results form the basis for additional study. This indicates that there is another dark side of opiates that many people don't suspect," explains senior author Linda Watkins, a professor in the Department of Psychology and Neuroscience. "It shows that trauma, including surgery, in combination with opiates can lead to chronic pain." She and the study's co-author are calling for more study into the association between opioids and chronic pain. They are not alone in their work, with a few earlier small-scale projects involving humans showing a correlation between postoperative opioids and chronic pain as long as 1 year afterwards. (Click for more...) Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering 4/20/2018 4:05:01 AM Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 A meta-analysis tackled the question of whether baseline LDL-C level influences the extent to which mortality-based outcomes are achieved following LDL-C lowering therapy. Researchers considered 34 studies with more than 270,000 participants, 136,299 of whom received more intensive pharmacological intervention for high cholesterol and 133,989 of whom received less intensive intervention, such as randomization to a placebo or control group. More intensive exposure was associated with a deeper reduction in risk of both all-cause and cardiovascular mortality: the primary co-outcomes. This correlation was absent, however, among patients whose baseline LDL-C level was below 100 mg/dL. The findings suggest that the greatest benefit from LDL-C–lowering therapy may occur among patients with baseline LDL-C levels at or above that threshold. (Click for more...) Pharmacist-prescribed contraception still hard to find 4/20/2018 4:05:01 AM Pharmacist-prescribed contraception still hard to find Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 According to study findings, a new state law allowing pharmacists in California to directly prescribe hormonal contraceptives has not had much impact on practice. The statute, effective as of April 2016, aims to widen access to contraception—especially for women with financial and/or geographic limitations. However, report Priya Batra, MD, and colleagues at the University of California, Riverside, only a fraction of pharmacies contacted by telephone 6 months to 1 year after implementation were actually taking advantage of the opportunity. The researchers employed a "secret shopper" approach, with a caller posing as an insured teenage girl seeking information on pharmacist-prescribed contraception. Of 480 pharmacies, only 376 had a pharmacist or other staff member available to discuss the issue and only 22 confirmed that they could actually provide pharmacist-prescribed contraception. Moreover, just 5 said they could offer all four hormonal methods of contraception allowed under the state law: oral contraception, patch, vaginal ring, or depot injection. Writing in Obstetrics & Gynecology, the investigators note that the new law does not oblige insurers to reimburse pharmacists who provide the new service, perhaps removing an economic incentive for offering it. As a result, they conclude, pharmacy-prescribed contraception will need to be paired with mandated insurance coverage, pharmacist certification and credentialing, and other legal maneuvers to create a broader strategy. (Click for more...) CVS Health teams up with Job Corps to enhance workforce development opportunities for aspiring pharmacy technicians 4/20/2018 4:05:01 AM CVS Health teams up with Job Corps to enhance workforce development opportunities for aspiring pharmacy technicians Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 CVS Health is working with Job Corps in an effort to expand work-based learning and externship opportunities for individuals studying to become pharmacy technicians. Participating Job Corps campuses include those in Long Beach, CA; Monroe, VA; St. Petersburg, FL; and Tulsa, OK. A pilot program is also launching this summer at the Pittsburgh campus. The new partnership will enable Job Corps to place students at local CVS pharmacies to learn directly from pharmacists and operations leaders. Students who successfully complete the training will be eligible to apply for a job at CVS Pharmacy. Job Corps students who are roughly 75% through with their career training are required to complete work-based learning or an externship with a local employer to gain work experience. The expanded relationship with Job Corps is part of the myCVS Journey Pathways to Health Care Careers that introduces students of all ages to career opportunities in health care. (Click for more...) More than 25,000 prescription drugs missing from LA state database 4/20/2018 4:05:01 AM More than 25,000 prescription drugs missing from LA state database Wed, 04/18/2018 - 20:00 cbaker_admin Fri, 04/20/2018 - 04:05 The Louisiana Legislative Auditor conducted an https://www.lla.la.gov/PublicReports.nsf/BEF55FA81E8CD40F8625826C007083…; target="_blank">audit of the state prescription monitoring program (PMP) following an increase in overdose deaths and an increase in the dispensing of addictive medications in the state. By law, the Louisiana Board of Pharmacy must maintain a PMP that monitors controlled substances and drugs of concern dispensed in the state. The audit more than 25,500 prescriptions dispensed during 2016 with outstanding errors that were not corrected and not entered into the PMP database as of November 2017. Auditors also found more than 14,000 missing hydrocodone and oxycodone prescriptions in a 1-year period between workers' compensation and Medicaid prescriptions. (Click for more...) What patients don’t know about NSAIDs may lead to misuse 4/19/2018 9:29:04 AM What patients don’t know about NSAIDs may lead to misuse Thu, 04/19/2018 - 09:34 ehaberkorn@aph… Thu, 04/19/2018 - 09:29 With a multitude of nonprescription as well as prescription NSAID products, it has been difficult to document how patients actually take NSAIDs. (Click for more...) CVS Health expands West Virginia opioid disposal 4/19/2018 3:05:01 AM CVS Health expands West Virginia opioid disposal Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 CVS Health announced it is installing safe medical disposal kiosks in 19 CVS Pharmacy locations throughout West Virginia. In addition, the CVS Health Foundation will make a $20,000 grant to Westbrook Health Services in Parkersburg, WV, to support opioid addiction recovery. CVS Health vice president of professional services Thomas Davis said: "We are expanding our safe medication disposal efforts to provide more locations where people can safely dispose of unwanted medications, getting them out of medicine cabinets where they could be abused. Our safe medication disposal initiative, and our funding for community organizations supporting addiction recovery in West Virginia, are an extension of CVS Health's purpose of helping people on their path to better health." Westbrook Health Services provides behavioral health services in eight West Virginia counties. The grant, CVS said, will support the organization's Community Partner Outreach Initiative for Health. (Click for more...) Aetna to reorganize ahead of CVS deal 4/19/2018 3:05:01 AM Aetna to reorganize ahead of CVS deal Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 Ahead of its planned $69 billion acquisition by CVS Health, Aetna said Tuesday it will reorganize its business units. The insurer said it would divide its business into a health care segment and a "corporate/other" category that will include discontinued products, divested contracts, and corporate expenses that do not support the company's business operations. CVS Health announced plans to acquire Aetna last December. (Click for more...) First medical marijuana pharmacy in New Orleans area gets permit approved 4/19/2018 3:05:01 AM First medical marijuana pharmacy in New Orleans area gets permit approved Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 New Orleans pharmacist Ruston Henry of H&W Drug Store Inc. has been selected to operate one of the first medical marijuana pharmacies in New Orleans, the state Pharmacy Board reported. The decision followed testimony from five applicants vying for the Region 1 permit. A seven-member subcommittee of the board ranked the companies, while the rest of the board became an advisory panel in charge of awarding the operating permit. In arguing for his pharmacy to win the bid, Henry told the board his location was the best site because it was near other retail outlets, close to the interstate, and would share a parking lot with a nearby substation of the New Orleans Police Department. He described himself as a second-generation pharmacist who took over the business his father launched more than half a century ago. (Click for more...) Association of a smartphone application with medication adherence and blood pressure control 4/19/2018 3:05:01 AM Association of a smartphone application with medication adherence and blood pressure control Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 To determine if a smartphone application could help patients exert better control of their blood pressure, researchers recruited more than 400 adults for a randomized study. Participants in the MedISAFE-BP trial had confirmed uncontrolled hypertension, for which they were prescribed anywhere from 1–3 treatments. A total of 209 patients were randomly assigned to download and use the app—which included reminder alerts, medication adherence reports, and optional peer support—while 202 served as controls. At 12-week followup, self-reported adherence to antihypertensive drugs improved slightly in the intervention group and not at all in the control group. Mean systolic blood pressure, declined, respectively, by 10.6 mm Hg and 10.1 mm Hg, for an insignificant between-group difference of -0.5. Although there was no difference in blood pressure between the two sets of patients, those who used the smart app did register a small improvement in adherence, which is implicated in as many as 50% of all cases of uncontrolled hypertension. (Click for more...) Legislation aims to safely dispose of unwanted drugs 4/19/2018 3:05:01 AM Legislation aims to safely dispose of unwanted drugs Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 A bipartisan group of U.S. senators has introduced the Safe Disposal of Unused Medication Act of 2018, a bill allowing for the safe disposal of unwanted drugs when patients are receiving hospice care at home. Under current federal regulations, hospice staff are not allowed to dispose of unused medicines, even after the patient has died. The legislation would permit hospice staff (physicians and registered nurses) or emergency medical services professionals to dispose of controlled substances when a patient dies or a treatment expires. Qualified hospice programs must have a written policy and procedure for drug disposal in place to be distributed to a patient’s family. Additionally, hospice employees must hold a conversation with a patient's family member or representative about medicine disposal policies when a controlled substance is first ordered. (Click for more...) U.S. regulators float ideas for boosting medical device safety 4/19/2018 3:05:01 AM U.S. regulators float ideas for boosting medical device safety Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 A new FDA plan lists concepts and proposals for improving federal medical device oversight, targeting better safeguards on pacemakers, artificial joints, medical scanners, and other products. The agency will consider requiring more training for physicians who implant high-risk devices, which may demand new guidelines or regulations. FDA also will consider additional scrutiny of devices for women; new ways to encourage manufacturers to enhance safety, including faster approval for devices that appear safer than what is available; and mandating cybersecurity features for electronic devices such as implantable heart pacemakers and defibrillators. In addition, the agency will request more funding for a public-private system designed to track insurance claims, electronic health records, and other data sources for early signs of device problems. The project is calculated to cost $250 million over 5 years to become operational, and is currently slated to receive $30 million from device manufacturers. (Click for more...) West Virginia reaches $550k settlement in opioid case 4/19/2018 3:05:01 AM West Virginia reaches $550k settlement in opioid case Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 The West Virginia Attorney General's office has reached a $550,000 settlement with a pharmacy it accused of distributing about 10 million doses of opioids to a county with less than 25,000 people. The office had argued that, for over a decade, Larry's Drive-in Pharmacy failed to identify suspicious prescriptions or evaluate if it was dispensing a questionable amount of opioids. The pharmacy, which is now closed, denies all wrongdoing and liability and claims that its actions were legal and in accordance with all regulations. "Every aspect of the pharmaceutical supply chain bears responsibility the senseless death brought upon our state," said state Attorney General Patrick Morrisey. "This settlement demonstrates my commitment to go after all parties, regardless of size, to ensure their conduct adhere to best practices so that our state can reach her full potential." (Click for more...) Canadian pharmacy fined $34 million for illegal imports 4/19/2018 3:05:01 AM Canadian pharmacy fined $34 million for illegal imports Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 A judge in Montana approved on Friday $34 million in fines for an online pharmacy that imported counterfeit cancer therapies and other unapproved pharmaceuticals into the United States. While Canada Drugs promoted itself as a safe alternative for patients to save money on costly treatments, U.S. prosecutors said the company's business model is completely based on illegally importing unapproved and misbranded products from Canada and elsewhere around the world. Prosecutors said the company has made at least $78 million through illegal imports, including a fake version of the cancer drugs bevacizumab (Avastin—Genentech). On April 13, U.S. District Judge Dana Christensen approved federal prosecutors' recommended sentences that included $29 million forfeited, $5 million in fines, and 5 years' probation for Canada Drugs. In addition, company founded Kris Thorkelson was sentenced to 6 months' house arrest, 5 years' probation, and a $250,000 fine. The deal also calls for Canada Drugs to permanently halt the sale of all unapproved, misbranded, and counterfeit drugs and surrender all of the domain names for the many websites it used to sell the products. The Partnership for Safe Medicines, an advocacy group, had urged the judge to impose harsher penalties to deter future crimes. (Click for more...) Sessions tries to put new pressure on drug companies in opioid crisis 4/19/2018 3:05:01 AM Sessions tries to put new pressure on drug companies in opioid crisis Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 Attorney General Jeff Sessions on Tuesday proposed new regulations that could severely limit the amount of opioids that drug companies can produce and force them to account for scores of illegitimate prescriptions across the country. The regulations would change how DEA sets production quotas for drug manufacturers. Those companies would have to work with states, CDC, and other federal and state agencies to justify the number of drugs they send to medical providers. "Under this proposed new rule, if DEA believes that a company's opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make," Sessions said. While the change allows DEA to more actively track where pharmaceutical companies send their products, a 2016 law hamstrings the ability of the agency to stop shipments. The announcement was spurred by a lawsuit filed by the attorney general of West Virginia, Patrick Morrisey, who accused DEA of allowing companies to create their own quotas for drug manufacturing, without justifying where those drugs were going. Sessions's proposed change must still go through the federal rule-making process before going into effect. It will be published in the Federal Register and opened to public comment in the coming days. (Click for more...) FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia 4/19/2018 3:05:01 AM FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 FDA approved on Tuesday burosumab (Crysvita—Ultragenyx Pharmaceutical) for the treatment of adults and children aged 1 year and older with x-linked hypophosphatemia (XLH). The rare, inherited form of rickets causes low levels of phosphorus in the blood and leads to impaired bone growth and development in children and adolescents as well as problems with bone mineralization throughout a patient's life. "XLH differs from other forms of rickets in that vitamin D therapy is not effective," said Julie Beitz, MD., director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "This is the first FDA-approved medication for the treatment of XLH and a real breakthrough for those living with this serious disease." XLH affects about 3,000 children and 12,000 adults nationwide. The safety and efficacy of burosumab were studied in four clinical trials. The placebo-controlled trial found that 94% of adults taking burosumab once a month achieved normal phosphorus levels, compared with 8% of those taking a placebo. For children, 94%–100% of patients treated with burosumab every 2 weeks achieved normal phosphorus levels. The most common adverse events in adults taking burosumab were back pain, headache, restless leg syndrome, decreased vitamin D, dizziness, and constipation. The most common adverse effects for children were headache, injection site reaction, vomiting, decreased vitamin D, and pyrexia. Burosumab received Breakthrough Therapy designation as well as Orphan Drug designation. (Click for more...) Mortality associated with use of SGLT-2 inhibitors, GLP-1 agonists, and DPP-4 inhibitors for type 2 diabetes 4/19/2018 3:05:01 AM Mortality associated with use of SGLT-2 inhibitors, GLP-1 agonists, and DPP-4 inhibitors for type 2 diabetes Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 A network meta-analysis sought to determine how SGLT-2 inhibitors, GLP-1 agonists, and DPP-4 inhibitors compare in reducing mortality and cardiovascular events in patients with type 2 diabetes. The British study included 236 trials and more than 176,000 participants. According to the data, the use of SGLT-2 inhibitors or GLP-1 agonists was associated with reductions in all-cause and cardiovascular mortality compared with DPP-4 inhibitors and the control groups. In addition, the SGLT-2 inhibitors were associated with further cardiovascular benefits for heart failure events compared with incretin-based therapies and control groups as well as for myocardial infarction events compared with control groups. The authors note, "Of the 3 classes tested, SGLT-2 inhibition may be preferred over the incretin-based therapies based on their association with lower mortality and their favorable adverse event profile." The researchers also report that the use of DPP-4 inhibitors was not associated with reduced mortality compared with placebo or no treatment. (Click for more...) Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden 4/19/2018 3:05:01 AM Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden Tue, 04/17/2018 - 20:00 cbaker_admin Thu, 04/19/2018 - 03:05 With tumor mutational burden demonstrating potential as a biomarker for non-small-cell lung cancer (NSCLC) and the combination of nivolumab/ipilimumab looking good as a treatment option, researchers put both of these developments together in a Phase III trial. The study population included patients with stage IV or recurrent NSCLC not previously treated with chemotherapy, stratified according to whether tumor programmed death ligand 1 (PD-L1) expression was at least 1% or if it was below that threshold. Participants with high tumor mutational burden were equally randomized to one of three treatment arms: nivolumab alone, nivolumab plus ipilimumab, or chemotherapy. Patients with a low tumor mutational burden, meanwhile, were evenly randomized to nivolumab plus ipilimumab, nivolumab with chemotherapy, or chemotherapy only. Among patients with high mutational burden, as determined by the FoundationOne CDx assay, progression-free survival was significantly prolonged with the combination treatment vs. chemotherapy. At 1 year, the outcome was documented in 42.6% of the nivolumab plus ipilimumab patients compared with 13.2% of the chemotherapy patients. The benefit of nivolumab plus ipilimumab over chemotherapy was seen across subgroups, including patients with a PD-L1 expression level of at least 1% and those with a lower level. The results uphold the benefit of nivolumab plus ipilimumab in NSCLC and the utility of tumor mutational burden as a biomarker for patient selection. (Click for more...) WVU Benefits Open Enrollment continues through May 15; HSC session set for April 25 4/19/2018 12:00:00 AM WVU Benefits Administration is hosting a Benefits Information Table at the Health Sciences Center in HR, G211-B on Wednesday, April 25 from 1 to 3 p.m. (Click for more...) Safety violations compound pain of opioid analgesic shortages 4/18/2018 2:37:50 AM Safety violations compound pain of opioid analgesic shortages Mon, 04/16/2018 - 20:00 cbaker_admin Wed, 04/18/2018 - 02:37 Safety violations at a major compounding pharmacy are exacerbating hospital shortages of opioid analgesics, particularly in California where health officials have prohibited sales from one of its plants. In late March, California's Board of Pharmacy barred the distribution of medications from a Texas factory belonging to the company, PharMEDium. The decision came after the pharmacy board had issued a cease-and-desist order against the plant in February, citing "an immediate threat to the public health or safety." In December, FDA issued an inspection report on PharMEDium's Tennessee plant that led the company to voluntarily cease production there. PharMEDium, one of the nation's largest compounding pharmacy companies, is owned by AmerisourceBergen and supplies medications to approximately 77% of hospitals nationwide. The shortage of analgesics has forced doctors to turn to second-choice pain drugs and increased their use of local anesthetics such as lidocaine. But now, even those local anesthetics—lidocaine, ropivacaine, and bupivacaine—are in short supply due to manufacturing problems and back orders, according to doctors and federal regulators. Shortages have hit California health care providers especially hard. They must contend with the state crackdown on PharMEDium's Texas plant, which produces local anesthetics, and federal scrutiny of the Tennessee plant, which produces the injectable opioids. (Click for more...) Boots on the ground: Reports from CDC's disease detectives 4/17/2018 11:05:02 PM Boots on the ground: Reports from CDC's disease detectives Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 23:05 CDC is holding this week its 67th annual Epidemic Intelligence Service (EIS) conference in Atlanta. The meeting of disease detectives highlights cutting-edge investigations and outbreak responses by EIS officers and their laboratory counterparts, the Laboratory Leadership Service (LLS) fellows. "CDC's EIS officers are our front line of defense for health threats both domestically and abroad," said CDC Director Robert R. Redfield, MD. "These dedicated professionals deploy more than 200 times in any given year to help investigate outbreaks and respond to other public health crises, and the knowledge we gain during EIS investigations helps inform future prevention efforts that save lives and protect people's health." The conference this year will include four special sessions exploring critical public health topics, including the Rohingya refugee crisis in Bangladesh, the need for innovative use of "big data" in public health, the 1918 influenza centenary, and the U.S. opioid overdose epidemic. In addition, four EIS officers will provide behind-the-scenes looks at their investigations in a TED-style talk, covering topics such as the use of geographic information systems to conduct a vaccination campaign in Somalia, and tracking, testing, and building lab capacity for Legionella. Other presentations at the conference will discuss occupational patterns in drug and opioid overdose deaths, initial public health laboratory response after Hurricane Maria, hepatitis A outbreak among homeless people, and monkeypox reemerging in Nigeria, among others. (Click for more...) Pembrolizumab plus chemotherapy in metastatic NSCLC 4/17/2018 10:05:02 PM Pembrolizumab plus chemotherapy in metastatic NSCLC Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 Adding pembrolizumab to standard chemotherapy led to significantly longer overall survival and progression-free survival for patients with previously untreated metastatic nonsquamous non–small-cell lung cancer (NSCLC), compared with chemotherapy alone, new research shows. The Phase III study randomly assigned more than 600 patients with metastatic nonsquamous NSCLC who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for four cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. After a median of 10.5 months' followup, the estimate rate of overall survival at 12 months was 69.2% in the pembrolizumab-combination group and 49.4% in the placebo-combination group. All PD-L1 categories that were assessed saw an improvement in overall survival. The median progression-free survival was 8.8 months in the pembrolizumab-combination group, compared with 4.9 months in the placebo-combination group. Rates of adverse events of grade 3 or higher were similar in the two groups: 67.2% in the pembrolizumab-combination group and in 65.8% in the placebo-combination group. A key question for further study, the researchers note, is whether the addition of pembrolizumab to pemetrexed and a platinum-based drug has greater efficacy than pembrolizumab monotherapy in these individuals. (Click for more...) Adjuvant pembrolizumab vs. placebo in resected stage III melanoma 4/17/2018 10:05:02 PM Adjuvant pembrolizumab vs. placebo in resected stage III melanoma Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 More than 1,000 adult patients with resected, high-risk stage III melanoma participated in a study to gauge the efficacy of pembrolizumab as an adjuvant therapy. In all, 514 patients were randomized to receive the programmed death 1 (PD-1) inhibitor and 505 were allocated to placebo. Treatment was administered intravenously every 3 weeks for a period of up to about 1 year. One of the primary outcomes was recurrence-free survival, which at median followup of 15 months was 75.4% with pembrolizumab vs. 61.0% with placebo. The other primary endpoint, recurrence-free survival among patients whose disease was positive for the PD-1 ligand, was 77.1% with pembrolizumab and 62.6% with placebo. Safety was also assessed, with trial-related adverse events of grades 3–5 reported in 14.7% of the pembrolizumab patients and 3.4% of the placebo recipients. The findings from the Phase III study suggest that 200 mg of pembrolizumab taken every 3 weeks for as long as 1 year increases recurrence-free survival among advanced melanoma patients, with no new toxic effects. (Click for more...) PrEP campaign aims to block HIV infection and save lives in D.C. 4/17/2018 10:05:02 PM PrEP campaign aims to block HIV infection and save lives in D.C. Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 As part of a push to lower the incidence of HIV in the District of Columbia, health officials are pinning their hopes on widespread uptake of pre-exposure prophylaxis (PrEP). Research has demonstrated that the two-drug combination of emtricitabine/tenofovir disoproxil fumarate (Truvada—Gilead) can lower the risk of infection by more than 90%, yet the therapy is scantily used by high-risk patients. In some cases, people are unaware of the option—with some providers withholding the option out of fear that it will encourage risky sexual behavior, although research does not show that to be the case. In other instances, patients may be anxious to maintain the privacy of their sexual orientation, even with their own physician, and avoid the stigma associated with HIV. In order to halve the rate of new infections in the city by 2020, local experts say the number of patients taking PrEP will need to increase more than fourfold. To get the word out, they are bombarding the nation's capital with sexy commercials and social media campaigns and even enlisting the help of PrEP users who can better convince their peers of the benefits of treatment. (Click for more...) Will blinatumomab's expanded FDA approval open the door for wider use of MRD as a biomarker or endpoint? 4/17/2018 10:05:02 PM Will blinatumomab's expanded FDA approval open the door for wider use of MRD as a biomarker or endpoint? Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 FDA recently expanded the approval of blinatumomab (Blincyto—Amgen) to treat patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). This marks the first time FDA has used MRD as a biomarker for a regulatory decision, as the trial for the approval used a molecular assay for MRD to choose study patients and to evaluate the response to therapy with blinatumomab. It remains to be seen if the approval will create other opportunities to use MRD more broadly among developing treatments for blood cancers like ALL, multiple myeloma (MM), acute myeloid leukemia, chronic myeloid leukemia, or chronic lymphocytic leukemia. An FDA spokesman said the agency "would be open to working with other sponsors on development pathways that involve using MRD," adding there are MM, indolent non-Hodgkin lymphoma, and other trials currently using MRD as an endpoint or biomarker. Cancer drug developers have long desired to use MRD as an endpoint. A 2017 FDA analysis observed the significant interest in using MRD in clinical trials of hematologic malignancies, especially as a possible surrogate endpoint to expedite drug approval, though surrogacy has not yet been established in most hematologic malignancies. (Click for more...) Amazon shelves a plan to sell drugs to hospitals 4/17/2018 10:05:02 PM Amazon shelves a plan to sell drugs to hospitals Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 Amazon has reportedly shelved its plan to sell and distribute pharmaceutical products after considering it last year. The company is instead focused on selling less sensitive medical supplies to hospitals and smaller clinics through Amazon Business. The change in plan comes partly because Amazon has not been able to convince big hospitals to change their traditional purchasing process, which typically involves a number of middlemen and loyal relationships. Additionally, some say Amazon would need to build a more sophisticated logistics network that can handle temperature-sensitive pharmaceutical products. Amazon has still not completely ruled out getting into the pharma distribution space eventually. Multiple reports have speculated that the company will someday add a direct-to-consumer prescription drug business. Amazon Business could also reconsider getting into the pharma space once it gains more scale, according to people familiar with the matter. (Click for more...) Hourican named CVS Pharmacy president 4/17/2018 10:05:02 PM Hourican named CVS Pharmacy president Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 CVS Health has named Kevin Hourican president of CVS Pharmacy. "We're pleased to have Kevin at the helm of CVS Pharmacy," said CVS Health COO Jon Roberts. "He has a proven track record of bringing innovative new programs and services to our patients and a strong ability to lead our retail pharmacy team. We believe that Kevin will bring his extensive consumer and retail skills to our front store business as well, and I have no doubt he will be able to further transform our stores to become the front door of health care for consumers, patients and caregivers." Hourican joined CVS Health in 2012 and most recently served as CVS Pharmacy's executive vice president of retail pharmacy. He succeeds Helena Foulkes, who recently took over as CEO of Hudson's Bay. Hourican had been serving as interim head of CVS Pharmacy while the company looked for a successor. (Click for more...) Walmart signals continued interest in health care space through remodel of pharmacies 4/17/2018 10:05:02 PM Walmart signals continued interest in health care space through remodel of pharmacies Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 Walmart says it will remodel 500 stores across two dozen states, primarily in Texas and Florida. The changes will be funded through its $11 billion capital expenditure plan, and will include updated pharmacy areas equipped with private consultation rooms. Walmart already operates walk-in care clinics in Georgia, South Carolina, and Texas, according to the company's website. The clinics are staffed by certified nurse practitioners and offer primary acute care services, wellness and preventative care, labs services, and chronic illness treatment and management. Walmart is also said to be in talks for a merger with Humana. There are few details about the planned deal, but it is expected to allow Walmart to benefit from Humana's specialization in Medicare Advantage plans. Opening up the market for older adults to Walmart could bring additional traffic to its clinics and pharmacies. It would also give Walmart a boost against Amazon, which is offering Medicaid beneficiaries discounted Prime memberships. (Click for more...) Many Americans overusing or misusing OTC medications 4/17/2018 10:05:02 PM Many Americans overusing or misusing OTC medications Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 OTC drugs are safely used by millions of Americans, but many people are overusing or misusing them with potentially dangerous consequences, experts say. The Mayo Clinic's David Dodick, MD, and colleagues recently conducted a population-based study across the United States and found that 15% of patients who had at least one headache within the past 30 days overused OTC analgesics. Dodick says some patients have the perception that anything that can be purchased without a prescription is not actually a drug. Yet for people with certain risk factors, overuse and misuse of certain OTC analgesics can potentially lead to gastrointestinal problems such as ulcers and kidney disease. "We know now all of them increase the risk significantly of myocardial infarction or having a heart attack and stroke," adds Dodick. Although he is not worried about addiction to OTC analgesics, he expressed concern that these medications are habit-forming. He has seen some patients get into the habit of taking the drugs in anticipation of getting a headache, for example. (Click for more...) Italy serves cautionary lesson for new Trump drug plan 4/17/2018 10:05:02 PM Italy serves cautionary lesson for new Trump drug plan Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 The Trump administration is pushing drug plans that tie costs to performance as a way to lower health-care spending, a strategy that has been followed in Italy for years with little success. So called "outcomes-based" contracts—which reimburse insurance companies for treatments that turn out to be ineffective—has been promoted by the pharmaceutical industry as a way to lower health care costs, while also avoiding broad price cuts. The Trump administration has drafted an executive order that would direct federal programs to seek out such contracts. Italy has been using such deals with companies such as Novartis, GlaxoSmithKline, and AstraZeneca for more than a decade and officials say their experience points to few gains—offering a cautionary tale for the much bigger U.S. market. Regulators and drug companies tend to disagree on how to measure a drug's efficacy. That remains a major stumbling block to contracts being signed, health officials say. Also, the success of these programs depends on how well patients' treatments are tracked. In Italy, it falls on doctors to claim back the money from pharmaceutical companies when the drug doesn’t work for their patients, but they do not receive a financial incentive to do so. (Click for more...) Pharmacies sue Express Scripts over claim it stole patients 4/17/2018 10:05:02 PM Pharmacies sue Express Scripts over claim it stole patients Mon, 04/16/2018 - 20:00 cbaker_admin Tue, 04/17/2018 - 22:05 Six out-of-state pharmacies are suing Missouri-based Express Scripts, alleging the company stole business from them by forcing their customers to switch to Express Scripts' mail-order pharmacy. The pharmacies—which provide prescriptions to consumers in Idaho, Tennessee, Oregon, and Indiana—assert they are required to share certain patient information with Express Scripts or risk not getting paid for the medications they dispense. However, it is the sharing of this patient information that exposes them to losing customers to Express Scripts, the pharmacies claim in a lawsuit filed March 28. Express Scripts uses the information—which includes the prescribed medication—to identify potential mail-order clients, the suit claims. Express Scripts has denied the allegations contained in the lawsuit. (Click for more...) What you need to know about statutes of limitations 4/17/2018 9:26:53 PM What you need to know about statutes of limitations Tue, 04/17/2018 - 13:59 tenglish@aphanet.org Tue, 04/17/2018 - 21:26 Do you remember the details of interactions with every patient you had 2 months ago? What about 1 year ago? The reality is that health care providers cannot rely on memory to recall details that could make the difference in successfully defending themselves against a lawsuit or state licensing board complaint. (Click for more...) Navigating disability insurance needs as a New Practitioner 4/17/2018 9:16:44 PM Navigating disability insurance needs as a New Practitioner Tue, 04/17/2018 - 15:00 tenglish@aphanet.org Tue, 04/17/2018 - 21:16 When I talk with New Practitioners about building a solid financial foundation, insurance is a critical piece of the puzzle. Alongside other competing priorities such as student loan debt, it is easy to think, “Do I really need to spend my money here?” (Click for more...) Find your voice in the NPN 4/17/2018 8:54:39 PM Find your voice in the NPN Tue, 04/17/2018 - 12:00 tenglish@aphanet.org Tue, 04/17/2018 - 20:54 The end of my term as New Practitioner Advisory Committee (NPAC) chair in March was a bittersweet time. Approaching my fifth graduation anniversary, the New Practitioner Network (NPN) has truly become a “home,” where I’ve created lasting friendships and had valuable leadership experiences along the way. (Click for more...) Stress relief via a four-legged friend 4/17/2018 5:45:09 PM Stress relief via a four-legged friend Tue, 04/17/2018 - 22:59 tenglish@aphanet.org Tue, 04/17/2018 - 17:45 New Practitioners are often caught up in the day-to-day routine of residency, fellowship, and careers. Stress becomes a present reality and often you do not realize your workload is all-consuming. It is helpful to incorporate healthy distractions into your routines to remind you that there is more to life than work. (Click for more...) APhA2018 through the eyes of a New Practitioner 4/17/2018 5:31:19 PM APhA2018 through the eyes of a New Practitioner Tue, 04/17/2018 - 17:00 tenglish@aphanet.org Tue, 04/17/2018 - 17:31 The APhA Annual Meeting & Exposition is not just a meeting you attend, but rather one that provides you with a variety of different experiences. (Click for more...) Omega-3 fatty acid supplementation for the treatment of dry eye disease 4/16/2018 10:05:01 PM Omega-3 fatty acid supplementation for the treatment of dry eye disease Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Omega-3 fatty acid supplements appear no better than placebo at relieving symptoms and signs of dry eye disease, according to new research. The multicenter study, funded by NIH's National Eye Institute, involved 535 patients with moderate-to-severe dry eye disease. Participants were randomly assigned to receive a daily oral dose of 3,000 mg of fish-derived omega-3 fatty acid capsules or an olive oil placebo capsule. Each active capsule contained 400 mg of EPA and 200 mg of DHA, for a total daily dose of 2,000 mg of EPA and 1000 mg of DHA, while each placebo capsule contained 1,000 mg of refined olive oil. Patients who were regularly using treatments for dry eye disease, systemic medications that are known to cause ocular dryness, systemic glucocorticoids, or other immunosuppressive agents were allowed to continue those medications. The data showed that the mean change in the Ocular Surface Disease Index score was not significantly different between the two groups, including across prespecified subgroups. In addition, there were no significant changes between the two groups in mean changes from baseline in the conjunctival staining score, corneal staining score, tear break-up time, and result on Schirmer's test. Rates of adverse events were similar in the two groups. "We found no evidence of a beneficial effect of n-3 fatty acid supplements as compared with placebo supplements among patients with dry eye disease," the researchers concluded. (Click for more...) Coastal Meds to recall all products marketed as sterile 4/16/2018 10:05:01 PM Coastal Meds to recall all products marketed as sterile Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 FDA announced that Coastal Meds has launched a voluntary recall of all non-expired products marketed as sterile due to visible particles in some of the drug vials for injection. Visible particulates and poor sterile production practices were observed during a recent FDA inspection of Coastal Meds. While the drug compounder initiated a voluntary recall of all products intended to be sterile on April 5, 2018, it has yet to inform the public—as requested by FDA. The agency, therefore, is warning health care professionals to dispose of and not administer any sterile drug products intended for injection that were produced and distributed by Coastal Meds. Further information is available https://www.fda.gov/Drugs/DrugSafety/ucm604613.htm target="_blank">here. (Click for more...) Physician prescribing of opioids to patients at increased risk of overdose from benzodiazepine use in the United States 4/16/2018 10:05:01 PM Physician prescribing of opioids to patients at increased risk of overdose from benzodiazepine use in the United States Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Researchers analyzed a decade's worth of public data in order to flesh out new opioid prescribing patterns in Americans with elevated risk of overdose from benzodiazepine use. They identified patients aged 20 years and older who received a new opioid prescription while already taking a benzodiazepine. The study included more than 13,000 ambulatory visits, with analysis revealing a significant upward spike in new opioid prescriptions during 2005–10 but a downward trend during 2010–15. The finding suggests that the upswing in opioid-related deaths of late cannot be blamed predominantly on physicians writing new prescriptions. Even so, the rate of prescribing to patients taking benzodiazepines was higher than it was for the general population. The research results open the door to improve quality of care for patients in pain, for whom an initial opioid prescription is the gateway to future abuse—but is also avoidable. (Click for more...) Many cirrhosis patients harbor multidrug-resistant bugs 4/16/2018 10:05:01 PM Many cirrhosis patients harbor multidrug-resistant bugs Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Multidrug-resistant bacterial pathogens are prevalent among inpatients with cirrhosis and infections, according to researchers at the International Liver Conference in Paris. Findings from the Global Study of the International Club of Ascites showed the incidence rate at 34% across the board and about 18% for North America. It was highest for Asia—India, in particular. Overall, based on data from more than 1,300 patients at 46 sites worldwide, the rate of extensively resistant bacteria was about 8%—again, with the greatest exposure in India. In his presentation, Paolo Angeli, MD, PhD, of University-Hospital Padova in Italy noted that recognizing patient risk is paramount, because the strongest predictor for survival is selection of an appropriate first-line treatment. If initial therapy fails, the study determined, the risk of death increases seven-fold. Roughly 20% of the cirrhosis patients involved in his study did not survive, he reported, including 21% of inpatients with no bacterial organisms, 27% of inpatients with multi-drug resistant disease, and 43% of inpatients with extensively-multidrug-resistant infections. (Click for more...) As cancer drug prices climb, value not keeping pace 4/16/2018 10:05:01 PM As cancer drug prices climb, value not keeping pace Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Anti-cancer medications represent a major share of global drug spending, but patients and insurers may be getting less for their money, according to a new analysis in the Journal of Oncology Practice. Researchers led by Kelvin Chan, MD, Sunnybrook Health Sciences Centre in Toronto, found that the cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015. They analyzed 42 clinical trials of the drugs approved by the FDA in 2006–15 and found that monthly drug costs increased by 9% per year while incremental costs rose by 21% annually. Chan's team used two scales—the American Society of Clinical Oncology's (ASCO) Value Framework and the European Society of Medical Oncology's Magnitude of Clinical Benefit Scale—to measure clinical benefits of the newly approved drugs. However, neither scale showed any improvement in clinical benefit during the study period, nor were there any associations between the clinical value of a drug and its monthly or incremental cost. (Click for more...) Express Scripts to roll out innovative pilot program 4/16/2018 10:05:01 PM Express Scripts to roll out innovative pilot program Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Starting this fall, Express Scripts will launch a 12-month pilot for a performance-based community pharmacy network. The pilot will examine the impact of rewarding pharmacies that fill prescriptions for Express Scripts members and demonstrate a positive improvement on individual members' medication adherence. Express Scripts will work with each participating pharmacies to provide them with the necessary tools, such as allowing them to track their performance and identify gaps in care via a web portal. Retailers will compete against each other in the network pilot, thus incentivizing them to improve their performance through relative assessment, rather than predefined benchmarks. For this pilot, participating plan sponsors will have the ability to select the four therapy classes where they would like to see an improvement in medication adherence that will be used to measure each pharmacy's performance. "Pharmacists are one of the most trusted of all health care professionals and their frequent interactions with our members present enormous opportunities to positively impact patient health," said Amy Bricker, president, Supply Chain, Express Scripts. "We have supported quality-based retail network for Medicare plans for several years now, and this new pilot will draw from that experience, as well as our strong relationships with the pharmacies in our networks, to test the impact of this innovative, value-driven network for commercial plan sponsors." (Click for more...) Rite Aid to escalate 'wellness' focus for stores in Albertsons deal 4/16/2018 10:05:01 PM Rite Aid to escalate 'wellness' focus for stores in Albertsons deal Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 The proposed merger between grocery chain Albertsons and Rite Aid will help create a differentiated brand in the U.S. retail market that focuses on "food, health, and wellness," say Rite Aid executives. In Rite Aid's fourth quarter, the companies remodeled another 38 stores, bringing the number of wellness stores to 1,805, which account for about two-thirds of the chain's store count. An additional 132 Rite Aid stores are expected to be remodeled in fiscal 2019, executives said during the company's quarterly earnings call. With the transfer of more than 1,900 stores to Walgreens Boots Alliance completed at the end of March, Rite Aid executives say they can now focus on the merger with Albertsons and growing its businesses. The combination of Rite Aid, which operates RediClinic, and Albertsons will encompass 319 health clinics and 4,345 pharmacies after the merger closes. The larger, yet-to-be named company makes its debut on the New York Stock Exchange later this year. The merger will involve extending the Rite Aid pharmacy brand into most of Albertsons groceries that include Safeway and Vons. (Click for more...) 'Cool caps' are helping cancer patients keep their hair through chemo--for a high price 4/16/2018 10:05:01 PM 'Cool caps' are helping cancer patients keep their hair through chemo--for a high price Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Scalp cooling is a new therapy that can limit hair loss related to chemotherapy, but the cost and refusal of some insurers to cover it could be prohibitive for some patients. In Massachusetts, neither the state's Medicaid system nor Blue Cross Blue Shield of Massachusetts cover scalp cooling. Blue Cross said the scalp-cooling treatments have not been shown to be widely effective. Doctors at Dana-Farber Cancer Institute and Massachusetts General Hospital, however, say there is good evidence that cold caps can prevent hair loss for patients undergoing certain chemotherapy treatments. The two hospitals have rented scalp-cooling machines from a British company. Patients pay the company, Paxman, for a custom-made cooling cap and each treatment session; out-of-pocket expenses are limited to $2,200. Financial aid is available for individuals who cannot afford the cost. While cold caps that work with dry ice can be effective and cost less, they are cumbersome, according to doctors. Some cancer patients do still use this method, which often sees patients bringing coolers of ice into the hospital and having a friend or relative refresh the ice in their cap every 20 minutes. A small study in the Journal of the American Medical Association last year found that one-half of women who used the scalp-cooling machines held on to at least half of their hair, vs. none of the women who did not use them. While a number of the women experienced adverse effects such as chills, dizziness, headaches, and nausea, only 4 of the 182 participants dropped out of the study because the cap was too cold. (Click for more...) Drug company 'shenanigans' to block generics come under federal scrutiny 4/16/2018 10:05:01 PM Drug company 'shenanigans' to block generics come under federal scrutiny Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 FDA Commissioner Scott Gottlieb said recently that drug makers must "end the shenanigans" that prevent competing products from reaching the market. The Trump administration is targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine. he maneuvers by brand-name drug firms, Gottlieb said, "frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies." The Federal Trade Commission is investigating the practice, which it says can forestall generic competition and "potentially preserve a brand firm’s monopoly indefinitely." Legislation to ensure access to drug samples for generic drug manufacturers has broad support in Congress from both parties. Brand-name drug companies say such legislation is not needed. FDA approved 1,027 generic drugs last year, a record number, and nearly 90% of prescriptions are filled with generic medicines, suggesting that generic manufacturers have generally been able to obtain the samples they need, the brand-name companies say. (Click for more...) Maryland law against price-gouging by drug companies is unconstitutional, appeals court rules 4/16/2018 10:05:01 PM Maryland law against price-gouging by drug companies is unconstitutional, appeals court rules Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 The 4th Circuit Court of Appeals ruled Friday that a Maryland law passed last year to stop sharp increases in the price of generic medicines is unconstitutional, a setback to new efforts by states to keep down the cost of drugs. The appeals court found that the law regulates trade that happens beyond Maryland's borders, and so is prohibited by the so-called dormant commerce clause. Judge Stephanie Thacker wrote an opinion ordering a lower-level federal judge to bar the law from going into effect. "Maryland cannot, even in an effort to protect its consumers from skyrocketing prescription drug costs, impose its preferences in this manner," Thacker wrote. Maryland passed the legislation after reports of steep price increases for generic drugs, especially those where a small number of companies controlled the market for medicines doctors deem essential. The law gave authorities new power to monitor price changes and seek fines or court orders reversing increases. But the Association for Accessible Medicines, a drug industry trade group, sued the state over the law, saying it was unconstitutional. The organization has argued that the measure could hurt competition by scaring companies out of the business of making generic drugs and actually drive up prices. (Click for more...) Trump talks TPP, but trade partners say, not so fast 4/16/2018 10:05:01 PM Trump talks TPP, but trade partners say, not so fast Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 Although President Donald Trump is talking about getting the United States into a Pacific Rim trade agreement, any serious effort to do so would be fraught with difficulty. After the United States dropped out of the Trans-Pacific Partnership (TPP) last year, the remaining 11 nations struck their own TPP deal. Each country is now moving ahead with ratification. Trump's suggestion that the United States might want to join after all left many nations concerned that the process could get disrupted. U.S. participation in the TPP is still an attractive prospect for many of its members because it would lead to lower tariffs in the huge American market. The original TPP deal, signed in February 2016, was led by the United States under the Obama administration and, at Washington's insistence, included some provisions sought by U.S. pharmaceutical and movie companies. One generally required 8 years of patent protection for biotechnology drugs—a provision that Australia in particular fought against. Other provisions, opposed by Canada and New Zealand, would have extended copyright protection to 70 years after the death of an author from 50 years. Once the United States dropped out, the remaining 11 countries froze those provisions. (Click for more...) FDA takes action against dietary supplements containing very high levels of extremely concentrated or pure caffeine 4/16/2018 10:05:01 PM FDA takes action against dietary supplements containing very high levels of extremely concentrated or pure caffeine Sun, 04/15/2018 - 20:00 cbaker_admin Mon, 04/16/2018 - 22:05 FDA on Friday issued a new https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory…; target="_blank">guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. According to the agency, "These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses." FDA noted that one-half of a cup of a highly concentrated liquid caffeine can contain about 2,000 mg of caffeine and one teaspoon of a powdered pure caffeine product can contain about 3,200 mg of caffeine—equivalent to 20–28 cups of coffee. The recommended safe serving of highly concentrated or pure caffeine products is much lower, often at 200 mg of caffeine—equal to 1/16th of a teaspoon of pure powder or about 2.5 teaspoons of a liquid. However, powdered forms of caffeine are often sold in large bags and liquid forms are sold in bottles that may contain a gallon or more, and consumers may not have the correct tools to properly measure such a small amount. Even when they do, using a "heaping scoop" instead of a "level scoop," for example, can make a big difference in the amount used. FDA said the guidance does not affect other types of products that might also contain caffeine, such as prescription or OTC drugs or conventional foods. FDA Commissioner Scott Gottlieb, MD, stated: "We're making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We'll act to remove these dangerous bulk products from the market." (Click for more...) Nonoptimized medication therapy costs U.S. $528.4 billion a year 4/16/2018 8:45:12 AM Nonoptimized medication therapy costs U.S. $528.4 billion a year Mon, 04/16/2018 - 08:49 ehaberkorn@aph… Mon, 04/16/2018 - 08:45 Nonoptimized medication therapy costs the United States $528.4 billion a year, roughly 16% of the nation’s total health expenditure, according to researchers in a study published online in the Annals of Pharmacotherapy on March 1. (Click for more...) Dr. Suresh Madhavan to receive AACP's prestigious Dawson Award for Excellence in Patient Care Research 4/16/2018 12:00:00 AM The American Association of Colleges of Pharmacy (AACP) will recognize S. Suresh Madhavan, M.B.A., Ph.D., FAPhA professor and chair of the Department of Pharmaceutical Systems and Policy at the West Virginia University School of Pharmacy, for his innovative research addressing the profound health disparities in West Virginia. He will receive the Paul R. Dawson Award for Excellence in Patient Care Research on July 23 during the Science Plenary at Pharmacy Education 2018, the AACP Annual Meeting, in Boston, Massachusetts. (Click for more...) FDA finalizes guidances to speed the development of reliable, beneficial next generation sequencing-based tests 4/13/2018 7:05:01 PM FDA finalizes guidances to speed the development of reliable, beneficial next generation sequencing-based tests Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 FDA has finalized two guidances to further the efficient development of next-generation sequencing (NGS) technology. "As disease detection technologies rapidly evolve, so too must the FDA's approach to reviewing these new innovations," said FDA Commissioner Scott Gottlieb, MD. "The new policies issued today provide a modern and flexible framework to generate data needed to support the FDA's review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies." The first guidance, "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics," addresses an approach in which test developers may rely on clinical evidence from FDA-recognized databases to support clinical claims for their tests and help provide assurance of the accurate clinical evaluation of genomic test results. The second guidance, "Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing–Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases," includes recommendations for designing, developing, and validating NGS-based tests used to diagnose people with suspected genetic diseases. The guidances were issued following extensive feedback from the public and stakeholders who are developing NGS-based technologies. (Click for more...) Finding a treatment for ALS--Will gene editing cut it? 4/13/2018 7:05:01 PM Finding a treatment for ALS--Will gene editing cut it? Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 Treatment approaches based on clustered regularly interspaced short palindromic repeats (CRISPR)–Cas9 gene editing are offering new hope for patients with amyotrophic lateral sclerosis (ALS). Like many other neurodevelopmental conditions, the challenge with ALS lies in the need to suppress the expression of dominant mutant genes that cause disease. While several feasible options do exist, CRISPR–Cas9 may be the most exciting. The technique targets a specific gene sequence for exact gene editing and correction. It has produced promising results in animal models, but also some obstacles. In research on mice, for example, investigators delivered the gene-editing system immediately after birth, before the disease became active. Identifying the at-risk population in humans, however, would prove tricky—especially in cases where there is no family history. It remains uncertain, meanwhile, if the treatment strategy is still effective after disease onset. CRISPR–Cas9 also faces hurdles related to trial recruitment and regulatory approvals. (Click for more...) New affordable hepatitis C combination treatment shows 97% cure rate 4/13/2018 7:05:01 PM New affordable hepatitis C combination treatment shows 97% cure rate Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 Interim research reported at the International Liver Conference in Paris Thursday showed that an affordable hepatitis C combination treatment was safe and effective, with very high cure rates. According to Bernard Pécoul, executive director of the nonprofit research and development group Drugs for Neglected Diseases initiative (DNDi), "The results indicate that the sofosbuvir–ravidasvir combination is comparable to the very best hepatitis C therapies available today, but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programs." Ravidasvir is an oral NS5A inhibitor licensed to DNDi by Presidio Pharmaceuticals. The Phase II/III STORM-C-1 trial, which was conducted by DNDi and cosponsored by the Malaysian Ministry of Health, used medicines produced Egypt's Pharco Pharmaceuticals. Agreements set a target price of $300 for a 12-week treatment—an almost 100% drop from existing treatment prices in Malaysia. In the trial, some 300 adults with chronic hepatitis C infection were treated with ravidasvir–sofosbuvir for 12 weeks—for patients without cirrhosis of the liver—and for 24 weeks for those with compensated cirrhosis. Twelve weeks after treatment completion, 97% of the participants were cured. Even hard-to-treat patients, such as people with cirrhosis or those coinfected with HIV, had very high cure rates. (Click for more...) FDA clears everolimus tablets for tuberous sclerosis complex 4/13/2018 7:05:01 PM FDA clears everolimus tablets for tuberous sclerosis complex Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 FDA has approved everolimus tablets for oral suspension (Afinitor Disperz—Novartis) for the adjunctive treatment of adult and pediatric onset patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. TSC affects about 50,000 individuals in the United States and 1 million worldwide. More than 60% of patients with the rare genetic disorder have seizures that are resistant to anti-epileptic drugs. This is the first pharmacologic therapy approved in the United States for this indication. FDA based its decision on data from a 370-patient Phase III study which found the drug significantly reduced seizure frequency in both everolimus low exposure and high exposure compared with placebo. The drug has previously received approval for the treatment of certain patients with giant cell astrocytoma and renal angiomyolipoma. (Click for more...) Rite Aid shareholders sour on Albertsons deal 4/13/2018 7:05:01 PM Rite Aid shareholders sour on Albertsons deal Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 Some Rite Aid investors say they plan to oppose a merger with Albertsons, saying they believe the deal undervalues the pharmacy chain. Since the companies said they would merge on February 20, Rite Aid's share have dropped about 20%. Rite Aid announced Thursday that same-store sales dropped 1.7% in the fourth quarter, the sixth straight period of declines. Rite Aid shareholders who opposed the deal assert they are not getting a big enough share of the combined company and believe that Rite Aid would be better served overhauling its pharmacies by itself. Under the agreement, Rite Aid investors may exchange 10 of their shares for a share in the combined company plus $1.83 in cash, or alternatively 10 shares for 1.079 new shares. They would hold about 30% of the new company. Other shareholders say they do not want to invest in the grocery industry, which is facing challenges from Amazon.com and discounters. Rite Aid CEO John Standley said Thursday that the deal "makes sense for us strategically and financially. The merger will transform Rite Aid." Rite Aid has about 2,600 pharmacies, but the combined company would have more than 4,300, including those currently operated by Albertsons. Rite Aid reported Thursday that fourth-quarter revenue totaled $5.4 billion, lower than the $5.6 billion projected by analysts polled by Thomson Reuters. The company posted a profit of $767 million for the quarter, vs. a $21 million loss a year ago. Adjusted losses were 1 cent a share, which was in line with analyst expectations. Rite Aid said in a regulatory filing that federal regulators are allowing the merger to proceed. Standley said he expects the shareholder vote to be held in July. (Click for more...) Overdose antidote is supposed to be easy to get. It's not. 4/13/2018 7:05:01 PM Overdose antidote is supposed to be easy to get. It's not. Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 Three years after New York City Mayor Bill de Blasio and his wife, Chirlane McCray, announced that residents would be able to get naloxone from participating pharmacies without a prescription, a New York Times investigation reveals that only about a third of the pharmacies listed had the drug and would dispense it without a prescription. The city's list of locations that provide the drug is used on the city's website, the NYC Health Map, the Stop OD NYC app, and when someone calls 311. According to the investigation, telephone calls place to each of the listed pharmacies in March found spotty compliance. In some cases, the caller was told the pharmacy does not carry naloxone, while some pharmacy workers inaccurately said only the person in need of the drug could purchase it, and then only with a prescription. The investigation revealed that naloxone was hardest to find outside of Manhattan. In the Bronx, for example, only about 25% of the more than 100 pharmacies on the list carried naloxone and followed the protocol. In response to queries from the Times, Rite Aid, CVS, and Walgreens confirmed that naloxone was available without a prescription at all locations in New York, and they said they were reviewing procedures with employees at all locations in New York City. (Click for more...) Pharmacists can play key roles in improving health outcomes for at-risk older adults 4/13/2018 7:05:01 PM Pharmacists can play key roles in improving health outcomes for at-risk older adults Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 In recent years, pharmacy practice has transitioned beyond managing prescriptions to also directly managing patients and residents, writes Orsula Knowlton, PharmD, MBA, cofounder of Tabula Rasa HealthCare. Pharmacists have three evolving roles as a result of the drive toward value-based care, Knowlton writes. The first is in-home medication care specialists, who have proven more effective than other health care professionals in reconciling all medication lists into one comprehensive plan. In-home measures can significantly lower the 30-day readmission rates. Pharmacists' second role is precision-prescribing "quarterbacks." Patients and residents are often affected by business-focused contracts that result in reduced medication selection; but pharmacists can assist in the medication selection process, helping physicians and facility medical directors find alternatives to medications that might cause interactions. With pharmacogenomic data, prescribing becomes even more precise. Pharmacists' third role is managers of medication benefits. In many PACE (Programs of All-Inclusive Care for the Elderly) organizations, pharmacists collaborate with PACE and specialist prescribers to help optimize medication-related outcomes. In this high-risk population, pharmacists can identify whether a new medication regimen increases a person's risk for preventable adverse drug events. With the pharmacist in a real-time role, utilization, drug expenditures, and total costs of care have been shown to decline and stabilize. "Overall," Knowlton writes, "as value-based care moves from fee-for-service to fee-for-value, the pharmacist's role will continue to evolve into one of responsibility for medication outcomes, as well as for the accuracy and timeliness of access." (Click for more...) Independent specialty pharmacies develop turnkey solution 4/13/2018 7:05:01 PM Independent specialty pharmacies develop turnkey solution Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 The newly launched distribution model Turning Point has announced that it will begin working with drug manufacturers and payers on behalf of its member pharmacies. "Turning Point simplifies contracting and data collection as manufacturers and payers can partner with a single entity and gain access to all of these top-performing pharmacies," said Kyle Truitt, executive director of Turning Point. "This model offers coverage across all 50 states and provides access to 96% of all limited distribution drugs (specialty medications distributed through only a select group of pharmacies)." Turning Point is made up of eight leading specialty pharmacies across the nation. Truitt explained, "Turning Point is more than a group purchasing organization. We are a group of top-performing, independent pharmacies with like-minded leadership committed to providing knowledgeable clinical support, actionable data insights, and premier service to patients and referral providers, as well as the pharmaceutical manufacturers and payer partners we serve." (Click for more...) Electronic alerts lower coprescribing of opioids and benzodiazepines 4/13/2018 7:05:01 PM Electronic alerts lower coprescribing of opioids and benzodiazepines Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 The results of a quality-improvement project involving the Veterans Affairs (VA) Puget Sound Health Care System suggests that electronic medication alerts may help lower the coprescribing of opioids and benzodiazepines in high-risk patients. Investigators used the VA's electronic medical record system to automatically alert care providers prescribing either opioids or benzodiazepine when patients with high-risk conditions had prescriptions for the other drug class. Coprescribing of the two medications declined for high-risk patients with substance use disorder, sleep apnea, and suicide risk after the system was implemented. Researchers set up the alert system in 2014. Over the next year, the alert activated for 1,332 patients and cases of coprescription at VA Puget Sound dropped by 25% for patients with a diagnosis of substance use disorder, by 39% with sleep apnea group, and by 62% for patients at risk for suicide. Among those individuals who already had long-term prescriptions for both drugs, the percent filling both prescriptions fell to 69% after 6 months. The decreases in opioid analgesic prescribing may also reflect the VA's overall efforts to address the opioid epidemic and greater coordination between different medical services. The study results are published in Medical Care. (Click for more...) The FDA breakthrough-drug designation--4 years of experience 4/13/2018 7:05:01 PM The FDA breakthrough-drug designation--4 years of experience Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 FDA's breakthrough therapy designation was implemented in 2012 in an effort to bring key drugs with significant potential to market faster. A qualifying intervention must hold the promise of "substantial improvement" over existing therapies in terms of efficacy or safety. In the absence of an existing comparator, a product must demonstrate a "substantial and clinically meaningful effect" or show that it treats the underlying cause of a disease or prevents it from worsening rather than simply alleviates the symptoms. The 31 breakthrough therapies approved from 2013–16 were characterized by significantly shorter development and review times than nonexpedited interventions and even therapies placed under FDA's separate fast-track label; however, they did not necessarily deliver the "breakthrough" their labels suggested. That particular wording, coupled with the expedited approval process, can be misleading, leading patients and their providers to anticipate "miracle" drugs. Based on the experience of the approved therapies to date, however, it seems that a new treatment with only modest efficacy may still bear the label by simply meeting the technical requirements. To avoid overinflating expectations, authorities should consider removing the term "breakthrough" and conducting more thorough postmarket followup of these therapies to determine the true extent of benefit. (Click for more...) Navajo Nation lawsuit blames opioid makers for overdose deaths, addiction 4/13/2018 7:05:01 PM Navajo Nation lawsuit blames opioid makers for overdose deaths, addiction Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 The Navajo Nation has filed a federal lawsuit against pharmaceutical companies, distributors, and pharmacies for their roles in the opioid epidemic. In its lawsuit, the tribe said that prescription and illegal opioids led to more than 7,300 overdose deaths from 2014 through 2016 in Arizona, New Mexico, and Utah—the three states that include parts of the Navajo Nation. The tribe's suit, filed in U.S. District Court in New Mexico, names as defendants manufacturers Purdue Pharma and Endo Health Solutions and distributors McKesson Corp., Cardinal Health and AmerisourceBergen. Other defendants include CVS Health, Walgreens Boots Alliance, and Walmart. Citing CDC data, the lawsuit noted that opioids have taken a "particularly devastating" toll on Native American children. (Click for more...) Maine House overwhelmingly approves lifting age requirement for opioid antidote 4/13/2018 7:05:01 PM Maine House overwhelmingly approves lifting age requirement for opioid antidote Thu, 04/12/2018 - 20:00 cbaker_admin Fri, 04/13/2018 - 19:05 Lawmakers in Maine's House have voted in support of a bill to remove a 21-and-older age restriction on people in the state seeking to obtain naloxone without a prescription. Sponsored by House Speaker Sara Gideon, the bill reflects a compromise between the Maine Board of Pharmacy and the LePage administration in order to free up long-stalled rules. In February, the Board of Pharmacy voted to only allow adults aged 21 years or older to obtain naloxone from a pharmacist without a prescription. At a recent public hearing on the rules, nearly a dozen speakers argued there is no medical or health reason for such restrictions. The amended version of Gideon's bill states that pharmacists could prescribe and dispense naloxone "to a person of any age" who is at-risk of an opiate overdose or who may come in contact with individuals at risk of overdose, consistent with rules adopted by the board. Speakers said April 11 that the bill would not alter the rulemaking process but would help inform the board's decision regarding age limits. The 132-7 vote in the House shows the bill has strong support; it now goes to the Senate for consideration. (Click for more...) Pharmacists’ services and H.R. 592 noted at House opioid hearing 4/13/2018 3:35:46 PM Pharmacists’ services and H.R. 592 noted at House opioid hearing Fri, 04/13/2018 - 16:04 ehaberkorn@aph… Fri, 04/13/2018 - 15:35 Members of Congress, CMS, and health care leaders noted pharmacists’ services and H.R. (Click for more...) New evidence suggests patients may safely take triptans with SSRIs/SNRIs 4/13/2018 1:36:11 PM New evidence suggests patients may safely take triptans with SSRIs/SNRIs Fri, 04/13/2018 - 13:42 ehaberkorn@aph… Fri, 04/13/2018 - 13:36 Data published in JAMA Neurology in February questioned the basis of an established FDA advisory and might offer relief to those with comorbid headaches and depression. (Click for more...) FDA permits marketing of AI-based device to detect certain diabetes-related eye problems 4/12/2018 6:05:01 PM FDA permits marketing of AI-based device to detect certain diabetes-related eye problems Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 FDA announced Wednesday has permitted marketing of a medical device, the IDx-DR (from IDx LLC), that uses artificial intelligence to detect more than a mild level of diabetic retinopathy in adults with diabetes. The condition—the most common cause of vision loss among people with diabetes—occurs when high levels of blood glucose lead to damage in the blood vessels of the retina. "Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% of them do not see their eye doctor on a yearly basis," said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at FDA's Center for Devices and Radiological Health. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office." A clinical study of retinal images obtained from 900 patients found that IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time and was able to correctly identify patients who did not have more than mild diabetic retinopathy 89.5% of the time. (Click for more...) Experts urge caution on SARMs 4/12/2018 6:05:01 PM Experts urge caution on SARMs Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Health experts are warning that selective androgen receptor modulators, or SARMS, are not necessarily safe. Developed by drug companies as an alternative to anabolic steroids for individuals with age and disease-related muscle loss, many athletes and people who go to the gym are turning to SARMs to help them build muscle and improve their strength. FDA warned last fall that SARMS were unapproved drugs associated with "serious safety concerns," including the possibility of an increased risk of liver toxicity, heart attacks, and stroke. A study published soon after found that products marketed as SARMS were often misbranded and contained unlisted ingredients. About 40% contained hormones and unapproved drugs. Shalender Bhasin, MD, director of research programs in men's health, aging and metabolism at Brigham and Women's Hospital and an author of the JAMA study, noted the long-term effects of using SARMs are largely unknown. "We don't know whether these compounds are safe," he said, "but we do know that some of them have side effects." SARMS were developed decades ago to help with the age-related decline in muscle and strength that can begin around middle age and may contribute to falls and broken bones. Several trials now under way are investigating SARMs' usefulness in cancer patients, people recovering from hip surgery, and postmenopausal women with urinary incontinence linked with weak pelvic muscles. (Click for more...) Zika virus shedding in semen of symptomatic infected men 4/12/2018 6:05:01 PM Zika virus shedding in semen of symptomatic infected men Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 The results of a new CDC study indicate that shedding of infectious Zika virus in semen appears to be limited to the first few weeks after illness onset. The prospective study examined more than 1,300 semen samples from 184 men with symptomatic Zika virus infection. According to the data, Zika virus RNA was detected in the urine of 7 men (4%) and in the semen of 60 (33%). This includes semen samples from 22 of 36 men (61%) who were tested within 30 days of illness onset. While Zika virus RNA shedding in semen declined rapidly in the 3 months following illness onset, it continued for 281 days in 1 individual. Factors independently associated with extended RNA shedding included older age, less frequent ejaculation, and the presence of certain symptoms at the time of initial illness. The researchers detected infectious Zika virus from just 3 of 78 semen samples with detectable Zika virus RNA, all obtained within a month of illness onset and all with at least 7.0 log10 Zika virus RNA copies per milliliter of semen. (Click for more...) Associations between brain structure and connectivity in infants and exposure to SSRIs during pregnancy 4/12/2018 6:05:01 PM Associations between brain structure and connectivity in infants and exposure to SSRIs during pregnancy Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Expecting mothers increasingly are taking selective serotonin reuptake inhibitors (SSRIs), which in animal studies have been linked to fetal brain development. The effect of prenatal exposure on humans is not well understood, however, providing the impetus for a new cohort study. Conducted at Columbia University Medical Center and New York State Psychiatric Institute, the investigation used magnetic resonance imaging to compare brain development in exposed and unexposed infants. The study population included 21 babies whose mothers took nothing to treat their depression while pregnant, 16 infants whose mothers took SSRIs during pregnancy, and 61 healthy controls. In just the children with in-utero exposure to SSRIs, researchers documented significant increased gray matter volume in the right amygdala and right insula—areas of the brain implicated in emotional processing. They also observed, again in only the exposed babies, increased white matter structural connectivity between those two regions. The findings indicate that prenatal exposure to SSRIs has an association with fetal brain development in humans; and considering that related animal research has shown a correlation with post-adolescent anxiety and depressive behaviors, they underscore the importance of additional study on the potential long-term outcomes of these neurological changes. Ultimately, scientists may uncover the best way to treat mental disorders during pregnancy for the benefit of both mother and child. (Click for more...) Pharmacists: Competitors or collaborators? 4/12/2018 6:05:01 PM Pharmacists: Competitors or collaborators? Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Amid a growing shortage of physicians, pharmacists have been steadily expanding the services they provide, offering primary care services ranging from immunizations to laboratory tests to birth control prescriptions. While doing so allows physicians to focus on patients with more serious or chronic conditions and can also help in rural areas, for example, not all physicians are comfortable with pharmacists' growing roles. Some physicians may see this trend as an intrusion into their responsibilities; however, widespread changes in health care delivery are changing that. Health systems and large practices are embedding pharmacists into their care delivery teams, and individual physicians are setting formal agreements with community pharmacists about sharing patient care. Pharmacists are also being encouraged to take on a larger role in chronic care management, aiming to boost patients' health status and cut down on the need for costly emergency and hospital care. The Center for Medicaid and CHIP Services last year issued guidance urging states to permits pharmacists to dispense drugs "based on their own independently initiated prescriptions" through collaborative practice agreements with physicians, standing orders issued by the state, or other protocols. A key change for community pharmacists would be federal legislation that would allow pharmacists to be recognized by CMS as providers of care, and eligible to paid just as physicians are, if they work in a designated health-professional shortage area. More than 50 U.S. senators and more than 250 U.S. representatives are cosponsors to this legislation in their respective chambers. According to Russell B. Melchert, PhD, dean of the University of Missouri-Kansas City School of Pharmacy, "Recognizing pharmacists as providers of health care would be a game-changer." (Click for more...) Study: Despite decline in prescriptions, opioid deaths skyrocketing due to heroin and synthetic drugs 4/12/2018 6:05:01 PM Study: Despite decline in prescriptions, opioid deaths skyrocketing due to heroin and synthetic drugs Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Opioid prescribing has taken a sharp downturn in recent years as America tries to grapple with an epidemic of addiction and overdose, yet new statistics show the number of opioid deaths continues to climb. According to the American Action Forum, the growth rate for fatalities caused by prescription opioids has braked to 4.8% per year from 13.4% in 2010 and earlier. At the same time, however, deaths linked to inexpensive heroin and synthetic opioids, such as fentanyl, have escalated. The annual growth rates before and after 2010 are 4.1% and 31.2%, respectively, for heroin and 13.7% and 36.5%, respectively, for fentanyl. The findings, according to study co-author Ben Gitis, underscore the need not only to cut off the supply of illicit opioids but also to attack the root of the problem: addiction. (Click for more...) Experts warn prescription, OTC drugs polluting world's rivers 4/12/2018 6:05:01 PM Experts warn prescription, OTC drugs polluting world's rivers Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Prescription and OTC drugs in the world's rivers and fresh water systems are affecting the environment and wildlife, according to experts. At a meeting in Vienna on Tuesday, scientists predicted that if the trend continues, the problem will increase by 65% by 2050. Many of the drugs—including analgesics, hormones, antidepressants, and antihistamines—enter the waterways through human and animal waste, as only small amounts are filtered out in treatment plants or absorbed into the ecosystem. However, experts also noted that a significant reduction in use of drugs is needed. (Click for more...) Express Scripts to close Columbus pharmacy, lay off 488 4/12/2018 6:05:01 PM Express Scripts to close Columbus pharmacy, lay off 488 Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 Express Scripts is closing its Columbus, OH, pharmacy, resulting in layoffs of 488 workers. Express Scripts said layoffs will begin around June 10. The pharmacy fulfillment work done at the site will be performed at other sites across the country. The jobs to be lost include pharmacists, support staff, and other workers, according to a notice filed with the state. "As we continue to increase automation combined with the market adoption of electronic and digital tools, a thorough evaluation of our pharmacies shows that our future staffing needs are less than our current levels," the company said. The move comes shortly after health insurer Cigna announced plans to buy Express Scripts for $52 billion; Express Scripts said the decision to close the pharmacy is not related to that deal, however. (Click for more...) AAM adopts ethics code for members 4/12/2018 6:05:01 PM AAM adopts ethics code for members Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 The Association for Accessible Medicines (AAM) has adopted a code of business ethics for its members who manufacture generic and biosimilar medicines. The code, which takes effect September 1, establishes ethical and business standards for the group's members. "The AAM Code of Business Ethics stands out from other pharmaceutical industry codes because of AAM's clear recognition of the ethical value of access to medicines for patients," explained AAM president and CEO Chip Davis. "Our new code also prioritizes market competition as a driving force." The ethical code includes general provisions regarding medicine safety, competition, and clinical trials as well as sections about companies' relationships to health care professionals. (Click for more...) McKesson launches Health Mart Atlas 4/12/2018 6:05:01 PM McKesson launches Health Mart Atlas Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 McKesson Corporation has launched Health Mart Atlas, the largest network of high-performing community pharmacies dedicated to delivering high quality care with a personal touch. The joint venture—developed with McKesson AccessHealth and American Pharmacy Cooperative, Inc.'s (APCI's) American Pharmacy Network Solutions (APNS)—will manage core pharmacy services administrative organization (PSAO) services, including third-party PBM and payor contracting, credentialing, central pay, and MAC pricing appeals for community pharmacy, including all current AccessHealth and APNS members. "Health Mart Atlas was created to support the success of community pharmacies given the challenges they face today—lower reimbursements, narrow networks, industry consolidation, and a general sense of uncertainty," said Eyad Farah, vice president and general manager, Health Mart Atlas. "The strength of Health Mart Atlas ensures that community pharmacies are included in the right networks to continue to provide quality care to patients and perform to their highest potential as the industry evolves to value-based care models." With the joint venture, more than 6,600 pharmacies will benefit from being a member of the nation's largest PSAO. (Click for more...) FDA launches criminal investigation into unauthorized herpes vaccine research 4/12/2018 6:05:01 PM FDA launches criminal investigation into unauthorized herpes vaccine research Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 FDA is conducting a criminal investigation into research by a Southern Illinois University (SIU) professor who reportedly injected people with an unauthorized herpes vaccine, according to Kaiser Health News. The report says that Prof. William Halford—who died last June and was not a medical doctor—injected people with the vaccine in Illinois hotel rooms in 2013 and in St. Kitts and Nevis in 2016, without any standard safety oversight. FDA's Office of Criminal Investigations is said to be examining whether anyone from SIU or Rational Vaccines—Halford's former company—violated FDA regulations by assisting the professor with the unapproved research, sources familiar with the investigation say. Rational Vaccines, cofounded with Hollywood filmmaker Agustín Fernández III, received millions of dollars in private investment from investors following the Caribbean trial, including from billionaire Peter Thiel, a contributor to President Trump's campaign and a high-profile critic of the FDA. SIU has acknowledged that Halford's actions violated university rules and U.S. laws; however, school officials have denied knowledge of his misconduct. It is not yet clear where Halford manufactured the herpes vaccine. (Click for more...) Health care providers urge the government not to stop medication imports 4/12/2018 6:05:01 PM Health care providers urge the government not to stop medication imports Wed, 04/11/2018 - 20:00 cbaker_admin Thu, 04/12/2018 - 18:05 A letter from more than 50 health professionals calls on President Trump, members of Congress, and FDA to expressly permit personal prescription importation. The letter—signed by physicians, physician assistants, and nurse practitioners—also asks FDA to stop any actions that might block access to safe and affordable medicines from licensed pharmacies in other countries. Organized by Prescription Justice, the letter was sent in response to FDA's action in Florida last September against offices that help people, primarily older adults, buy less expensive drugs from Canada and other countries. FDA agents with search warrants warned the owners that importing drugs is illegal and that those who help "administer" such drugs risk fines or jail time. Concerned about the possibility of an FDA crackdown, the letter writers asserted: "Causing our patients to go without their needed medication is unacceptable and dangerous to their overall health and well-being." The health care providers noted that without the lower prices, some patients ration, or skip their medications altogether. Some 45 million Americans did not fill their prescriptions in 2016 due to cost. (Click for more...) Schools of Medicine and Pharmacy masters, PhD and MD/PhD investiture and commencement ceremony set 4/11/2018 12:00:00 AM Faculty are invited to celebrate the masters, PhD, and MD/PhD graduates in the Schools of Medicine and Pharmacy on Friday, May 11 at 9 a.m. in Okey Patteson Auditorium. (Click for more...) Ali Rezai appointed Rockefeller Chair in Neuroscience at WVU 4/9/2018 12:00:00 AM An investiture ceremony will be held on Monday at 4 p.m. in the Pylons Lobby of the WVU Health Sciences Center. (Click for more...) Alumna returns to campus as guest speaker for Louis A. Luzzi Lectureship Series 3/9/2018 12:00:00 AM Dr. Joanna Stollings, a 2003 graduate of the WVU School of Pharmacy, returned to campus March 9 as guest speaker for the Lois A. Luzzi Lectureship Series. (Click for more...) Science advocate, author to speak at WVU 3/7/2018 12:00:00 AM Paul A. Offit, M.D., a physician-scientist who is an expert in infectious diseases, immunology, virology and vaccine and the founding director of the Autism Science Foundation, will speak on "Scientific Misadventures: Learning from the Past," at noon, Friday, March 23 in the Patteson Auditorium at WVU's Health Sciences Center. (Click for more...) Health in West Virginia: The Next 150 Years 3/5/2018 12:00:00 AM West Virginia University President E. Gordon Gee will join Health Sciences Vice President and Executive Dean Clay Marsh, M.D., and WVU Medicine-WVU Hospitals President and CEO Albert L. Wright Jr., at a Health Sciences Town Hall on Wed., March 28 at noon in Okey Patteson Auditorium. The event is free and open to the public. (Click for more...) Schwinghammer retiring from WVU School of Pharmacy; Slain named new chair of clinical pharmacy 3/2/2018 12:00:00 AM Dr. Douglas Slain, an infectious disease specialist and professor at the West Virginia University School of Pharmacy, will be appointed the new chairperson of the School's clinical pharmacy department. Slain succeeds Dr. Terry Schwinghammer, who will retire this spring. (Click for more...) APhA annual meeting alumni reception 2/23/2018 12:00:00 AM The WVU School of Pharmacy will host an alumni reception at the 2018 APhA annual meeting in Nashville, Tennessee. (Click for more...) CDC to offer continuing education course on vaccine immunization in Morgantown 2/21/2018 12:00:00 AM The Centers for Disease Control and Prevention is offering a continuing education course titled CDC Pink Book Training: Epidemiology and Prevention of Vaccine Preventable Diseases on April 10-11, 2018, at the Morgantown Marriott at Waterfront Place in Morgantown, West Virginia. (Click for more...) WVU researcher wins national award; examines use of multiple medications among older cancer survivors 2/20/2018 12:00:00 AM Traci LeMasters, assistant professor in the School of Pharmacy, is a recipient of the American Association of Colleges of Pharmacy's New Investigator Award, which grants funding to early-career faculty to jumpstart independent research programs. She is one of only 16 people nationwide to receive the award this year. (Click for more...) WVU School of Pharmacy professor debunks common flu-related myths 2/14/2018 12:00:00 AM The Centers for Disease Control and Prevention (CDC) "FluView" map shows the virus is currently active in all 50 states, Washington, D.C., and Puerto Rico. WVU School of Pharmacy professor Douglas Slain, specializing in infectious diseases, answers some frequently asked questions and dispels common myths. (Click for more...) WVU Festival of Ideas to host panel of six opioid crisis experts 2/12/2018 12:00:00 AM Six experts on the state's opioid crisis will take part in a panel discussion Feb. 20 in the Charleston Civic Center Little Theater as part of West Virginia University's Festival of Ideas. "Understanding the Opioid Epidemic" starts at 7:30 p.m., and is co-sponsored by The Charleston Gazette-Mail. (Click for more...) Lockman appointed assistant VP for Experimental Therapeutics 2/9/2018 12:00:00 AM Dr. Paul Lockman, Professor and Chair of Basic Pharmaceutical Sciences in the School of Pharmacy, joined the Office of Research and Graduate Education as the Assistant Vice President for Experimental Therapeutics on January 1st in addition to his current roles. As a cross campus priority for collaboration, and an exciting area of focus at the HSC across diverse disciplines, Dr. Lockman brings the expertise and leadership to connect investigators and help develop new collaborations. (Click for more...) WVU groups to host body positivity event Feb. 19 2/9/2018 12:00:00 AM Groups and organizations across West Virginia University are collaborating to create a night of body acceptance for students. The WVU Collegiate Recovery Program, WELLWVU, Carruth Center, WVU Medicine Student Health and the WVU Women's Resource Center will host "Accepting EveryBODY" on February 19, from 6:30 p.m. to 8:00 p.m. at the WVU Recreation Center, Meeting Room A. (Click for more...) Nominations for Women in Science and Health Awards now open 2/8/2018 12:00:00 AM Sponsored by the Women in Science and Health (WISH) Committee, the Women in Science and Health Awards recognize outstanding achievements made by women working at West Virginia University Health Sciences. (Click for more...) Over-the-Counter Medication Donations Needed for Honduras 2/7/2018 12:00:00 AM Nurse Practitioner and DNP students from the WVU School of Nursing will provide primary care services in remote areas of Honduras in April. The team members pay their own way and bring all medications and supplies needed for the week. (Click for more...) WVU Rural Health Day 2018 2/1/2018 12:00:00 AM Registration is now open for the 3rd annual WVU Rural Health Day on Saturday, April 14, 2018 at the WVU Health Sciences Center in Morgantown. The purpose of WVU Rural Health Day is to give pre-health students interested in rural medicine the opportunity to hear about and participate in activities that will enhance, impassion, and provide support in the sometimes daunting path to applying to medical school. (Click for more...) SOP 'Dean's Hour' features lessons for success from 'The Wizard of Oz' 1/24/2018 12:00:00 AM Almost everyone has seen the 1939 movie "The Wizard of Oz," but what they may not realize is that it contains valuable lessons that are useful to all of us as we seek success in our personal and professional lives. (Click for more...) WVU School of Pharmacy announces Dean's List for fall 2017 term. 1/23/2018 12:00:00 AM Congratulations to all of our students who made the Dean's List! To make the list, a student must achieve a GPA of 3.5 or higher. Each recipient gets a signed letter from School of Pharmacy Dean, Bill Petros. Below is a complete list. (Click for more...) WVU School of Pharmacy seeks Director of Experiential Learning 1/23/2018 12:00:00 AM The WVU School of Pharmacy is seeking a Director of Experiential Learning at the rank of assistant professor to manage the APPE/IPPE programs and the Office of Experiential Learning. Apply online at https://goo.gl/18PTuk. (Click for more...) NIH funds WVU research to make diabetes and hypertension management a community activity 1/8/2018 12:00:00 AM Managing diabetes and high blood pressure can feel like a solitary enterprise dependent on relationships with objects (like pills or foods) and activities (like brisk walks or early bedtimes) instead of relationships with people, but a group of West Virginia University researchers is hoping to change that. (Click for more...) Mindful Morsels: Mindful Eating- January 16, 2017, 11:00 am, John Jones C 1/5/2018 12:00:00 AM Mindful Morsels is back for 2018. Mindful Eating will be held January 16, 2017, at 11:00 am in John Jones C. (Click for more...) Cancer Institute to sponsor talk on LGBTQI patient care 1/2/2018 12:00:00 AM WVU Cancer Institute will sponsor a talk on lesbian, gay, bisexual, transgender, queer and intersex (LGBTQI) patient care on January 9, 2018, from 12 to 1 p.m., in the Fukushima Auditorium. Mandi Pratt-Chapman, MA, associate center director, patient-centered initiatives and health equity for the George Washington Cancer Center, will present What You Should (and Want) to Know About Your LGBTQI Patients. Chapman's personal mission is to make evidence-based cancer control strategies available to more people as quickly as possible. (Click for more...) Pharmacy residency program ASHP accredited 1/1/2018 12:00:00 AM WVU Medicine Jefferson Medical Center's pharmacy residency program has been approved for accreditation by the American Society of Health-System Pharmacists (ASHP). (Click for more...) Maynor named director of student affairs and academic initiatives 12/14/2017 12:00:00 AM Lena Maynor, PharmD, has been appointed director of student affairs and academic initiatives for the Health Sciences Center at West Virginia University. (Click for more...) Schools of Medicine and Pharmacy alumni are WVU 2017 Homecoming Award recipients 10/4/2017 12:00:00 AM Three School of Medicine alumni and a School of Pharmacy graduate are being recognized by the WVU Alumni Association as 2017 Homecoming Award recipients. (Click for more...) Discussion leaders named for Post-Charlottesville Town Hall 9/19/2017 12:00:00 AM Seven volunteer discussion leaders will take part in the Health Sciences-WVU Medicine Town Hall this Wednesday (Sept. 20) at noon in the Patteson Auditorium at WVU. (Click for more...) WVU, WV attorney general expand eighth grade drug prevention program 9/12/2017 12:00:00 AM West Virginia Attorney General Patrick Morrisey and West Virginia University have partnered to expand a program aimed at sharing drug abuse prevention information with eighth grade students in West Virginia. The initiative, launched in March with the West Virginia University School of Nursing, now also involves West Virginia University's School of Pharmacy and two other universities. (Click for more...) Student and faculty international travel grants available 9/1/2017 12:00:00 AM In honor of the legacy of a long-time staff member in WVU's Global Health Program, the Global Engagement Office (GEO) at Health Sciences is pleased to announce that the application period for the Nancy Sanders Memorial Student Travel Grant and the Nancy Sanders Memorial Faculty Research Abroad Grant is now open. (Click for more...) WVU health care simulation week kicks off Sept. 12 8/30/2017 12:00:00 AM September 12 kicks off national Health Care Simulation Week, and the WV STEPS Center welcomes visitors to a series of events highlighting simulation education. (Click for more...) WVU in the News - Study aims to increase effectiveness of opioid addiction treatment 8/15/2017 12:00:00 AM A new study being conducted at WVU is aimed at increasing the effectiveness of addiction treatment. As many as 20 percent of people addicted to opioids will not respond to the standard treatment of suboxone. Genetic background is one of several factors WVU and the West Virginia Clinical and Translation Science Institute will study to provide better more patient-specific addiction treatment. Get the full story on WV Always. (Click for more...) West Virginia health research gets $55 million boost 8/1/2017 12:00:00 AM MORGANTOWN, W.Va. – Recommitting themselves to bring the benefits of research out of labs and hospitals and into the lives of West Virginia people and communities, a coalition of federal agencies, universities, hospitals and clinics will develop dozens of efforts over the next five years to battle addiction and cancer and reduce the impact of cardiovascular and neurological diseases. (Click for more...) Academy of Excellence in Teaching and Learning applications being accepted 7/20/2017 12:00:00 AM The WVU Health Sciences Faculty Development Program is now accepting applications, CVs and biographies for the 2017 Academy of Excellence in Teaching and Learning. (Click for more...) WVCTSI and WVU research aims to increase addiction treatment effectiveness 7/13/2017 12:00:00 AM MORGANTOWN, W.Va. – Up to 20 percent of people with opioid use disorder may not respond to standard treatment. A new study at West Virginia University seeks to understand why. (Click for more...) Madhavan named to Fulbright Specialist Roster 7/10/2017 12:00:00 AM The U.S. State Department has added S. Suresh Madhavan, Ph.D., of the WVU School of Pharmacy to Fulbright Specialist Roster for the next three years. (Click for more...) Leukemia Research Foundation supports cancer research at WVU 7/5/2017 12:00:00 AM The Leukemia Research Foundation has awarded $100,000 to Wei Du, M.D., Ph.D., of the West Virginia University Cancer Institute to investigate a method for increasing the effectiveness of stem cell transplantation. (Click for more...) Town Hall to focus on heart care and research Thursday, June 15 6/6/2017 12:00:00 AM Two WVU Medicine heart specialists will be the special guests at an open forum for Health Sciences and WVU Medicine faculty, staff, and students at noon on Thursday, June 15, in the Okey Patteson Auditorium in the Health Sciences Center. (Click for more...) Meet the Graduates: Lindsey Glotfelty 5/16/2017 12:00:00 AM When asked what she wanted people to know about her, Lindsey Glotfelty of Finzel, Maryland, stated it's not really what she wants people to know about her, but rather the messages she wants them to get. She has four lessons that she has learned in her life, and they are the principles by which she lives. (Click for more...) ASK WVU MEDICINE: Breast to Brain Cancer - Risks and Research 5/15/2017 12:00:00 AM Join Hannah Hazard-Jenkins, M.D. and Paul Lockman, Ph.D., doctors who are dedicating their efforts to research and treatment of breast cancer, at the next Ask WVU Medicine Community Conversation, Tuesday, May 23 at 6 p.m. in the WVU Health Sciences Center Fukushima Auditorium. (Click for more...) WVU School of Pharmacy's Suresh Madhavan recipient of Distinguished Pharmacy Alumni Award from Purdue University 5/9/2017 12:00:00 AM S. Suresh Madhavan, MBA, Ph.D., was the recipient of Purdue University College of Pharmacy's 2017 Distinguished Pharmacy Alumni Award. Dr. Madhavan was one of four Purdue alumni who received this award, which recognizes the recipient's outstanding achievements in professional and scientific endeavors. (Click for more...) Cancer researcher is first alum to lead WVU School of Pharmacy 4/26/2017 12:00:00 AM William (Bill) Petros, PharmD, FCCP, has been appointed to the position. (Click for more...) WVU recognizes Health Sciences staff and faculty 4/10/2017 12:00:00 AM West Virginia University honored 13 individuals and two teams at the Health Sciences Center for outstanding achievement on Wednesday, April 12 at 4 p.m. in the Pylons Lobby. (Click for more...) Frank Alderman, MD, to speak at WVU College of Business and Economics Distinguished Speaker Series 4/3/2017 12:00:00 AM Frank Alderman, MD, CEO of MedExpress and a graduate of the WVU Schools of Medicine and Pharmacy, will speak at the WVU College of Business and Economics's Distinguished Speaker Series on April 19 at 3:30 p.m. at the Morgantown Event Center. (Click for more...) WVU and WVCTSI fund two addiction projects 3/29/2017 12:00:00 AM MORGANTOWN, W.Va. – The West Virginia University (WVU) Addiction Task Force and West Virginia Clinical and Translational Science Institute (WVCTSI) have funded two new research projects to combat the opioid epidemic in the state. According to the Centers for Disease Control and Prevention, West Virginia continues to be devastated by this epidemic, having the highest rate of drug overdose deaths in the nation. (Click for more...) Vera Bradley Bingo Relay for Life fundraiser 3/28/2017 12:00:00 AM The West Virginia University School of Pharmacy Relay for Life Team and the Lambda Kappa Sigma student organization will be hosting a Vera Bradley Bingo at 1 p.m. on Sunday, April 2, in room 1909 at the WVU Health Sciences Center in Morgantown. Doors open at noon. (Click for more...) WVU health professions students provide information on fall risk prevention 3/24/2017 12:00:00 AM Students from the West Virginia University School of Pharmacy and School of Medicine Division of Physical Therapy visited Sundale Rehabilitation – Long Term Care on March 22 to discuss fall risk prevention. (Click for more...) HSC Interprofessional Education Week celebration is March 27-31 3/6/2017 12:00:00 AM Join us for the inaugural HSC Interprofessional Education Week celebration (Click for more...) New pharmacy scholarship honors longtime West Virginia pharmacist 3/6/2017 12:00:00 AM The Jack H. Smith Family Pharmacy Scholarship was established not only to honor Suzanne Smith-Fox's father, but to assist a student who holds the same values as her father – generosity, community involvement, quality citizenship and an outstanding passion for receiving an education. Jack was a 1956 graduate from the West Virginia University School of Pharmacy, and the endowed scholarship also honors Jack's father (Suzanne's grandfather) who was a pharmacist in Parkersburg, West Virginia. (Click for more...) WVU School of Pharmacy receives reaccreditation 2/9/2017 12:00:00 AM The West Virginia University School of Pharmacy's Doctor of Pharmacy (Pharm.D.) professional program recently received continued accreditation by the Accreditation Council for Pharmacy Education (ACPE). The accreditation is valid until 2025—a full eight years, which is the maximum length of time for ACPE's accreditation. (Click for more...)
 
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