DEA Increases Restrictions on Hydrocodone Combo Painkillers
The Drug Enforcement Administration (DEA) will reclassify hydrocodone combination drugs such as Vicodin as Schedule II pharmaceuticals, the category reserved for medical substances with the highest potential for abuse and/or addiction. People will need a new original signed prescription for every fill, according to the new scheduling, which takes effect in 45 days. The Wall Street Journal (WSJ Subscription Required), Full Report
New Vaccination Requirements Take Effect in Minnesota
The Minnesota Department of Health set new immunization requirements for school age children to take effect on Sept. 1. Newly required immunizations include Tdap (tetanus, diphtheria, pertussis) and meningitis vaccines for all students entering the seventh grade. The new rules also require certain immunizations for children entering early childhood education programs. Minnesota Star-Tribune
Ecolab is Donating Supplies to Fight Ebola
Ecolab is donating $1.8 million of germ-killing sanitizers and disinfectants in the global response to control the deadly Ebola virus. The donation of supplies will be shipped to West Africa. Ecolab, a maker of hygiene and safety products, was approached by an official at Johns Hopkins to help prevention and control efforts in West Africa, only to discover the company already was organizing a response. Ecolab will donate four to five truckloads of supplies, including hand soaps, hand sanitizers, disinfectant cleaners, bleach and other items, officials said. The donations will travel by ship from Ecolab sites in Europe and the United States, arriving in three to five weeks. St. Paul Pioneer Press
CDC Reports 68 Ebola Scares in U.S.
Over the past three weeks, 68 people have been tested for the Ebola virus in the U.S., according to the Centers for Disease Control and Prevention (CDC). According to the agency, the virus has claimed more than 1,200 lives in the West African nations of Guinea, Sierra Leone, Liberia and Nigeria. Despite the recent scares, there has yet to be a confirmed case in this country. ABC News
FDA OKs New Smartphone-Based Blood Glucose Monitor
The FDA granted 510(k) clearance to the Gmate Smart Blood Glucose Monitoring System, developed by South Korean device maker Philosys. The smartphone-based technology allows users to measure their blood glucose levels and send the results to clinicians via an iPad Touch, iPhone or iPad. FDA News
Diabetes Risk Rises Drastically
The risk for diabetes rose dramatically in the last decade, according to a study published in The Lancet Diabetes & Endocrinology. Of Americans born from 2000 to 2011, 40% will develop diabetes, double the risk of those born in the decade before. For minorities the risk is higher, with more than half of all Hispanic and non-Hispanic black women born from 2000 to 2011 at risk to develop diabetes in their lives. Bloomberg
NCPA urges swift congressional action on ‘any willing pharmacy’ legislation
In letters to the leadership of the House Energy and Commerce Committee and the House Ways and Means Committee, NCPA noted that H.R. 4577, the Ensuring Seniors Access to Local Pharmacies Act, had earned the support of 59 cosponsors, including 12 members of the House Energy and Commerce Committee and once again requested a congressional hearing on preferred networks.
In a separate letter to the Senate Finance Committee, a hearing was requested for after the August recess. Both letters highlighted the growth over the last four years of preferred networks that exclude participation of independent pharmacies.
“Most stakeholders would agree that Part D has been a success,” NCPA CEO B. Douglas Hoey, RPh, MBA, wrote in the letters, “but with any law comes unintended consequences, and we know that Congress did not intend to create access problems or limit choice for Medicare patients who depend on the face-to-face counseling services that independent pharmacies have offered them for many years.” Mr. Hoey continued, “Again, we respectfully request that you schedule an oversight hearing after the Congressional Work Period has concluded to examine ways to ensure that small business owner pharmacies have the same opportunities to compete in the Medicare Part D program as do larger, corporate pharmacies.”
Support for “any willing pharmacy” legislation continues to grow. For example H.R. 4577 is popular with voters, supported by key consumer advocates and has strong, bipartisan backing from dozens of cosponsors.
Learn more at www.NCPAnet.org/pharmacychoice.
Pharmacy Times
Medicaid Sign Ups Reach 7 Million Under Affordable Care Act
The U.S. Department of Health and Human Services (HHS) said, as of June, 7.2 million Americans have signed up for health insurance through government programs including Medicaid and the Children’s Health Insurance Program since the Affordable Care Act was launched Oct. 1, 2013. This brought overall Medicaid enrollment to 66 million people. HHS said 5.7 million low-income people remain uninsured in two dozen states that have not expanded Medicaid coverage under the Affordable Care Act. Chicago Tribune
ACA Saved Medicare Enrollees $11.5 Billion in Drug Costs: HHS
The Affordable Care Act (ACA) reduced the cost of prescription drug coverage, and saved seniors and people with disabilities more than $11.5 billion since 2010 through rebates and discounts, according to the Department of Health and Human Services (HHS). “By making prescription drugs more affordable, we are improving and promoting the best care for people with Medicare,” HHS Secretary Sylvia Burwell stated. HHS Press Release
GSK Submits Malaria Vaccine for Regulatory Approval
GlaxoSmithKline filed for regulatory approval for a malaria vaccine, the first ever developed. GSK’s 31 years of research resulted in RTS,S vaccine, which in trials showed 46% protection in toddlers and 27% protection in infants. If approved, GSK will begin selling the vaccine in a year with a 5% markup in costs with proceeds going towards future research. GSK is already working on a second generation of the vaccine and a one-dose oral medicine to cure a type of malaria that is present in Asia and Latin America. Fast Company
Many Americans Report Inappropriate Rx Drug Use: Survey
One in four Americans said they had purposely misused prescription drugs, according to a new survey by FindLaw.com. Up to 24% of respondents reported taking medication prescribed to someone else or providing their own prescription drug to others. Five percent said they have taken a prescription drug to get high, while approximately 3% reported paying someone for a prescription drug. Sys-Con Media
Pharmacists’ Interventions Boost Drug Adherence: Study
Community pharmacists’ interventions can help patients maintain drug adherence, according to a large, controlled study by University of Pittsburgh School of Pharmacy researchers appearing in Health Affairs. The researchers noted that greater adherence to medications can lead to a reduction in emergency department visits and hospital admissions, in turn lowering healthcare costs for a variety of conditions like asthma and diabetes. “This untapped resource could be harnessed and used to improve public health and reduce overall healthcare costs,” stated lead investigator Janice L. Pringle. Science Codex, Study Abstract
FDA’s New ‘Gluten-Free’ Labeling Standards Kick In
FDA issued a final rule setting the standard for labels on gluten-free foods, capping the amount of gluten allowed in foods bearing the label at 20 parts per million. The rule is designed to protect the estimated 3 million Americans with celiac disease, an autoimmune digestive condition that can only be managed by restricting gluten, a protein that occurs naturally in wheat, rye and barley. FDA Voice
House Advances Bill to Bring Better Sunscreens to U.S. Market
The House of Representative voted in favor of a bill that would require the FDA to speed assessment of new sunscreen ingredients awaiting regulatory approval, some of them for as long as a decade. The Sunscreen Innovation Act, passed on a voice vote, would impose FDA deadlines to ensure faster approval of existing and future sunscreen ingredient applications. Fox News
FDA reviewing what could be first biosimilar drug
The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved “biosimilar” drug, a cheaper, sort-of generic version of a biologic drug. Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.
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