Author: Peter

Aaron Steffenhagen, PharmD, BCPS, clinical pharmacy manager at University of Wisconsin Hospital and Clinics, discusses some ways pharmacists have helped in cardiopulmonary resuscitation efforts.

U.S. deaths from drug overdoses hit a record high in 2014, propelled by abuse of prescription painkillers and heroin, the Centers for Disease Control and Prevention said on Friday...Drug overdoses increased 6.5 percent in 2014 from a year earlier, killing 47,055 people. The highest rates of death from overdose were seen in West Virginia, New Mexico, New Hampshire, Kentucky, and Ohio, the CDC report said...Deaths from opioids such as prescription pain killers and heroin accounted for 61 percent of overdose deaths and increased 14 percent in 2014, the CDC said...Lower heroin prices, wider availability and higher purity are causing more overdoses, the agency reported. It recommends stricter guidelines for prescribing pain killers, expanded availability and wider access to naloxone, an antidote for opioid-related overdoses.

Prices rose faster than inflation for 22% of top generic drugs reviewed between 2005 and 2014, according to a report released Thursday by HHS' Office of Inspector General....Had those generic drugs been subject to the same requirement that branded drugs face—where manufacturers pay additional rebates to Medicaid when the price of a drug increases faster than inflation—Medicaid would have pulled in $1.4 billion in rebates for the top 200 generic drugs, according to the report...The OIG produced the report in response to a request from Congress to examine recent increases in generic drug prices and the effects of those prices on Medicaid and Medicare drug spending...the OIG didn't make any recommendations, noting that that the two-year budget deal recently passed by Congress would extend the rebates to generics starting in 2017. In a previous, similar report, OIG had recommended CMS consider seeking legislative authority to broaden the rebate program.

In time for the quit smoking New Year resolutions that are anticipated at the end of this month, the International Pharmaceutical Federation has outlined the wide variety of different ways in which pharmacists can reduce the use of tobacco through a new publication. The briefing document, "Establishing tobacco-free communities: A practical guide for pharmacists", gives a number of examples from around the world, showcasing pharmacists’ value in performing health promotion, triage and referral as well as other interventions.

Health-system pharmacists will inevitably face growing ethical challenges as their roles in patient care continue to evolve...ethical dilemmas embedded in health-system pharmacists’ everyday practice include competing interests, limited resources due to drug shortages, and an evolving health care delivery system that has shifted their role from dispensing medications to actively participating in direct patient care...One of the hot-button ethics issues in pharmacy currently is the trend of skyrocketing prescription costs and the lack of transparency in drug pricing decisions. Extremely high prices and lagging reimbursement may preclude health-systems from providing necessary medications to all patients who would otherwise benefit..."Patient welfare is at risk when the ethical perspective in health care is smothered by business and financial perspectives,"..."Patient well-being often hinges on the ability of health professionals to heed the ethical precepts of their calling."...Pharmacists are currently vying to gain support for an expanded role in patient care in the form of provider status, which will likely be more easily garnered if they are perceived as being on the side of patient care rather than the side of business interests.

Two months after a worker was found dead inside one of its cryochambers, a Henderson cryotherapy spa appears to be closed for good…On Dec. 10, a notice was posted on the front doors of Rejuvenice, 8846 S. Eastern Ave., saying the spa was more than $3,000 behind on its rent…Rejuvenice opened in July. And on Oct. 20, worker Chelsea Ake-Salvacion, 24, was found dead inside one of the spa's cryochambers… Ake-Salvacion's family hired the Las Vegas-based Richard Harris Law firm and the Bradley, Drendel & Jeanney law firm in Reno to investigate how she became trapped inside the chamber. Nevada's Occupational Safety and Health Administration office said it would not investigate because Ake-Salvacion died after business hours.

Perched on an exam table at the doctor’s office watching the clinician type details about their medical problems into their file, what patient hasn’t wondered exactly what the doctor is writing? As many as 50 million patients may have a chance to find out in the next few years, following the announcement this week of $10 million in new grants to expand the OpenNotes project, which works with medical providers to expand patient access to clinician notes...OpenNotes started in 2010 as a research project to examine what would happen if patients had easy access to their doctor’s visit notes, which may include a summary of their conversation, the symptoms patients describe and their doctor’s findings from a physical exam. Although patients have a legal right to their medical records, getting those documents is often difficult and expensive...Our goal is basically to make fully transparent medical records the standard of care across the country...The project works with providers, patient groups and electronic health record vendors, among others, to encourage the use of OpenNotes, and evaluates the impact of OpenNotes on health outcomes and costs...In addition to improving communication between patients and their providers, some research suggests OpenNotes may improve patients’ ability to stick with their medication regimens...

SPECIALTY PHARMACEUTICALS featured prominently in the FDA’s new drug approval and expanded indications list once again in 2015. Below is the first of a 2-part summary of specialty pharmacy–related FDA approvals and expanded indications that took place this year...Part 2, which will be featured in the next issue of Specialty Pharmacy Times, will include oncology drugs and late-breaking FDA actions...

Bleeding Disorders

• Ixinity (coagulation factor IX (recombinant), Emergent BioSolutions Inc)
• Nuwiq (coagulation factor VIII (recombinant), Octapharma)
• Coagadex (coagulation factor X (human), Bio Products Laboratory Ltd)
• Adynovate (antihemophilic factor [recombinant] pegylated, Baxalta Inc)

Inflammatory Conditions

• Cosentyx (secukinumab, Novartis Pharmaceutical Corp.)
• Humira (adalimumab, AbbVie)

Cystic Fibrosis

• Kalydeco (ivacaftor, Vertex Pharmaceuticals)
• Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals )

HIV

• Evotaz (atazanvir/cobicistat, Bristol-Myers Squibb Co)
• Prezcobix (darunavir/cobicistat, Janssen Therapeutics)
• Genvoya (cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide, Gilead Sciences, Inc)

Hepatitis C

• Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie Inc)
• Daklinza (daclatasvir, Bristol-Myers Squibb)
• Harvoni (ledipasvir/sofosbuvir, Gilead Sciences, Inc.)

• Glatopa (glatiramer acetate injection, Sandoz, Inc.)
• Betaconnect (Bayer HealthCare’s electronic auto injector - Betaseron (interferon beta-1b)

Specialty Ophthalmics

• Lucentis (ranibizumab, Genentech)
• Eylea (aflibercept, Regeneron Pharm)

Hypercholesterolemia

• Praluent (alirocumab, Sanofi-Aventis)
• Repatha (evolocumab, Amgen Inc)

Miscellaneous Specialty Approvals

• Natpara (parathyroid hormone, NPS Pharmaceuticals, Inc)
• Cresemba (isavuconazonium sulfate, Astellas Pharma US, Inc)
• Cholbam (cholic acid, Asklepion Pharmaceuticals LLC)
• Jadenu (deferasirox, Novartis Pharmaceuticals)
• Anthrasil (anthrax immune globulin intravenous [Human], Cangene Corp)
• Rapamune (sirolimus, Wyeth Pharmaceuticals)
• Promacta (eltrombopag, GlaxoSmithKline and Novartis Pharmaceuticals)
• Envarsus XR (tacrolimus extended-release tablets, Veloxis Pharmaceuticals A/S)
• Dysport (abobotulinumtoxinA, Medicis and Ipsen)
• Keveyis (dichlorphenamide, Taro Pharmaceutical Industries Ltd)
• Procysbi (cysteamine bitartrate, Raptor Pharmaceutical)
• Xuriden (uridine triacetate, Wellstat Therapeutics Corporation)

Martin Shkreli, the pharmaceuticals entrepreneur vilified for jacking up the price of a life-saving AIDS drug, said on Saturday that unrelated securities fraud allegations that resulted in his arrest this week were "baseless and without merit."…Federal prosecutors have alleged that Shkreli was running a Ponzi-like scheme at his former hedge fund and a company he headed before he took the helm of Turing Pharmaceuticals Inc, where he created an uproar in September when the company raised the price of the drug Daraprim from $13.50 to $750 a tablet…"I am confident I will prevail," Shkreli wrote on Twitter on Saturday… The allegations have amplified the public outrage over the brash, boyish-looking Shkreli, who has become the poster child for the issue of soaring prices for prescription medications.

Martin Shkreli, the pharmaceutical executive who became the public face of greed in the industry and who was arrested this week on securities fraud charges, has been replaced...Turing Pharmaceuticals, announced Friday that Shkreli will resign as chief executive and be replaced by Ron Tilles, the chairman of the board, who will serve as interim CEO..."We wish to thank Martin for helping us build Turing Pharmaceuticals into the dynamic research-focused company it is today, and wish him the best in his future endeavors," Tilles said in the statement...The announcement marks a swift and stunning fall for the 32-year-old Shkreli...Meanwhile, Turing is scrambling to reassure the medical community that Daraprim...will remain available. The company is sending letters to doctors to reiterate that patient assistance programs are intact and "distribution partnerships" with hospitals and clinics are being expanded.