Clinical Insights: June 30, 2017

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.

     

    New Drug Approval

    No new updates.

     

    New Indication Approval

    No new updates.

     

    New Drug Shortage

    June 21, 2017

    New Drug Recall Alert

    PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance – June 26, 2017 – PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. Read More.

    Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential for Lack of Sterility Assurance – June 23, 2017 – Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product. Read More.

     

    Clinical and Pharmacy News

    Walgreens Trims Rite Aid Deal After Antitrust Concerns – June 29, 2017 – Walgreens Boots Alliance Inc. and Rite Aid Corp. nixed their $9.4 billion merger agreement, which had been heavily scrutinized by antitrust regulators, and reached a new deal in which Walgreens instead will buy half of Rite Aid’s stores for $5.18 billion in cash. Read More.

    FDA Takes Key Steps Under New Drug Competition Action Plan – June 29, 2017 – The U.S. Food and Drug Administration (FDA) is taking two new key steps to increase competition in the market for prescription drugs and support entry of lower-cost alternatives. Read More.

    As Opioid Use Disorder Diagnoses Skyrocket Nearly 500%, Treatment Falls Behind – June 29, 2017 – A study from the Blue Cross and Blue Shield Association adds to the growing mound of evidence that the number of patients diagnosed with opioid use disorder far exceeds how many are getting treatment. Read More.

    Medication Management Guidelines Released for Rheumatic Disease Patients Undergoing Joint Replacement – June 29, 2017 – New guidelines have been released regarding the perioperative management of anti-rheumatic medication in patients undergoing total hip or knee replacement. The guidelines, published in Arthritis Care & Research, aim to reduce the risk of joint infection post-surgery, according to the authors. Read More.

    The Crazy Math Behind Drug Prices – June 29, 2017 – David Hernandez, a 44-year-old restaurant worker and Type 1 diabetic, didn’t have insurance from 2011 through 2014 and often couldn’t afford insulin—a workhorse drug whose list price has risen more than 270 percent over the past decade. As a result of his skimping on dosages, Hernandez in 2011 suffered permanent blindness in his left eye, and three years later he experienced kidney failure. Read More.

    FDA Unveils Plan to Eliminate Orphan Designation Backlog – June 29, 2017 – The U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. Read More.

    Researchers Develop Microneedle Patch for Flu Vaccination – June 27, 2017 – A National Institutes of Health-funded study led by a team at the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce robust immune responses and be administered safely with an experimental patch of dissolving microneedles. Read More.

    Study: AHA Guidelines to Treating Patients with Coronary Artery Disease – June 27, 2017 – The most recent dual antiplatelet guidelines from the American Heart Association and the American College of Cardiology encourage health care providers to take a customized approach to treating patients with coronary artery disease. Health care providers can find out more about the latest best practices for using dual antiplatelet therapy by going to www.heart.org/amitoolkit. Read More.

    Why Do Drug Prices Soar? Blame PBJs, PBMs, Weak Regulators, and CME – June 27, 2017 – What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into recent reports on these disparate causes to understand how Americans got into such dire shape with the costs of their medical care. Read More.

    Will Specialty Pharmacies Be Needed in the Future? – June 27, 2017 – What will the world of specialty pharmacy look like in 20 years? All signs point to the growth of specialty spending well into the foreseeable future. Now, one must wonder what these therapies will look like in 2036? As with any technology, drug development will continue to push the boundaries of innovation. Read More.

    FDA Tackles Drug Competition to Improve Patient Access – June 27, 2017 – The U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. Read More.

    DEA Releases 2017 Drugs of Abuse Resource Guide – June 27, 2017 – The U.S. Drug Enforcement Administration released the 2017 edition of Drugs of Abuse, A DEA Resource Guide. The Drugs of Abuse guide is released on a periodic basis and designed to be a reliable resource on the most commonly abused and misused drugs in the United States. For more information and to view the 2017 Drugs of Abuse resource guide, read more here.

    Value-Based Care Fueling Provider Demands on Health IT Companies – June 27, 2017 – Expectations for health IT companies are rising as a result of the transition to value-based care. Providers are increasingly experiencing pressure to improve information exchange at their practices and demanding clean, comprehensive, and actionable patient health data. In turn, they are increasingly turning to their technology partners for solutions. Read More.

    Statement from FDA Commissioner Scott Gottlieb, M.D., On the Importance of The Drug Quality and Security Act and Overseeing the Safety of Compounded Drugs – June 26, 2017In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths. Read More.

    Feeling the Pain of Rising Drug Prices? Blame the Middle Man – June 26, 2017 – While Washington wrangles with a replacement for Obamacare, patients across the country continue to battle one of the biggest everyday obstacles to good health care: Rising drug prices. Prescription drugs account for 10 percent of the $3.2 trillion in overall health care spending, outpacing all other health care services, according to government statistics. Read More.

    Significant Change Coming in 2018 in Tiering Exceptions Policy for Part D – June 23, 2017 – The Centers for Medicare and Medicaid Services (CMS) took a controversial step toward making drugs more affordable for Part D subscribers in its 2018 Call Letter.1 The CMS’s new policy requires prescription drug plans (PDPs) to give a member the “lowest available price” when granting a tiering exception, one of a number of affordability changes patient advocacy groups have been pushing for. Read More.

     

    340B in the News

    House Committee Issues Letter to HRSA Requesting Audit Documentation Regarding 340B Drug Pricing Program – June 28, 2017 – The House Committee on Energy and Commerce (Committee) sent a letter dated June 1, 2017, to the Health Resources and Services Administration (HRSA) Administrator expressing concerns about the growth and oversight of the 340B Drug Pricing Program (the Letter).  The Letter requested by June 15, 2017, documents collected by HRSA “referring to covered entity audits conducted during FY 2015 and FY 2016.” Read More.

    House Bill Would Narrow Orphan Drug Exception – June 28, 2017 – A recent House bill, titled the “Closing Loopholes for Orphan Drugs Act,” would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13, 2017. According to Representative Welch, the “legislation would close a loophole that allows drug companies to deny discounts for certain drugs,” thereby assisting certain providers that rely on “savings from federally mandated discounted prescription drugs.” Read More.

    Want to Protect Women’s Rights? Preserve 340B – June 27, 2017 – Women have fared poorly at the hands of Washington policymakers in recent months. Recently, leaked proposals revealed Trump administration plans to significantly roll back birth control coverage. That’s on top of recent congressional health care proposals that would defund Planned Parenthood, waive maternity care as an essential health insurance benefit and give states the leeway to charge women more for health insurance. Read More.

    Mr. President, Don’t Suck Up to Industries That Hate You – June 27, 2017 – In the past week, two news items came out of the Trump White House that should trouble supporters of the President’s populist agenda, and should send warning bells about the advice that President Trump may be receiving from his inner circle. Read More.

    A Bipartisan Consensus Against ‘Big Pharma’ Is Growing in Congress – June 26, 2017 – When President Trump, then candidate Trump, first fired a volley of insults and criticism at the pharmaceutical drug industry over their high drug prices, and pledged to use government to get a better deal, the reaction among the establishments of both parties was roughly comparable to that of the pope after reading the 95 Theses. Read More.