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November 26, 2018: FDA approves a new treatment for patients with acute myeloid leukemiaInboxxAPhA’s Pharmacy Today <PTdaily@aphanet.org> Unsubscribe9:11 AM (2 hours ago)to meView this email online.
 NOVEMBER 26, 2018  
FDA approves a new treatment for patients with acute myeloid leukemia
FDA News Release (11/21/18)

FDA has approved glasdegib (Daurismo—Pfizer) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood… Read More
 ▪ Ohio logs 900 cases of hepatitis A amid multistate outbreak  ▪ Mylan recalls 15 lots of valsartan tablets due to trace amounts of NDEA  ▪ FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease  ▪ Texas cases of infant botulism linked to honey pacifiers from Mexico  ▪ Walgreens, Humana are in preliminary talks to take stakes in each other  ▪ HHS activates aid for uninsured Californians in need of medications lost in wildfires  ▪ Kentucky allows pharmacies to treat influenza, strep throat patients without visits to the doctor  ▪ Spinal-cord stimulators cause more than 80,000 injury reports since 2008  ▪ Trump administration invites health care industry to help rewrite ban on kickbacks  ▪ Attorneys general fighting for right to regulate PBMs  ▪ Expansion of the Medicare 340B payment program   
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FDA approves new treatment for patients with acute myeloid leukemia
FDA News Release (11/21/18)

FDA has approved glasdegib (Daurismo—Pfizer) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. The National Cancer Institute estimates that in 2018, approximately 19,520 people will be diagnosed with AML and approximately 10,670 patients with AML will die of the disease. Almost one-half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities. The efficacy of glasdegib was studied in a randomized clinical trial in which 111 adult patients with newly diagnosed AML were treated with either glasdegib in combination with LDAC or LDAC alone. The trial measured overall survival (OS) from the date of randomization to death from any cause. Results demonstrated a significant improvement in OS in patients treated with glasdegib. The median OS was 8.3 months for patients treated with Daurismo plus LDAC, compared with 4.3 months for patients treated with LDAC only. The prescribing information for glasdegib includes a boxed warning to advise health care professionals and patients about the risk of embryo-fetal death or severe birth defects.
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Ohio logs 900 cases of hepatitis A amid a multistate outbreak
Associated Press (11/24/18)

Health officials in Ohio have recorded more than 900 cases of hepatitis A this year. By comparison, the state has seen only a few dozen cases in the past few years. This year’s cases come amid an outbreak around the state as well as in some nearby states. Many of the cases have required hospitalization, and one individual died. To help protect against the disease, health officials advise getting vaccinated against hepatitis A and practicing good hygiene.
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Mylan recalls 15 lots of valsartan tablets due to trace amounts of NDEA
FDA Recalls, Market Withdrawals, & Safety Alerts (11/20/18)

Mylan Pharmaceuticals has initiated a voluntary nationwide recall of 15 lots of valsartan-containing products due to the presence of trace amounts of N-Nitrosodiethylamine (NDEA), a probable human carcinogen. The recall includes six lots of amlodipine and valsartan Tablets, USP (including the 5 mg/160 mg, 10 mg/160 mg, and 10 mg/320 mg strengths), seven lots of valsartan tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg strength. The affected batches were distributed in the United States between March 2017 and November 2018.
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FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
FDA News Release (11/20/18)

FDA on November 20 approved emapalumab-lzsg (Gamifant—Novimmune) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH, a condition in which the body’s immune cells do not work properly. The cells become overactive releasing molecules, which leads to inflammation. The immune cells start to damage the body’s own organs, including the liver, brain and bone marrow. People with primary HLH usually develop symptoms within the first months or years of life. Symptoms may include fever, enlarged liver or spleen, and a decreased number of blood cells. The efficacy of the treatment was studied in a clinical trial of 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent or progressive disease during conventional HLH therapy or who were intolerant of conventional HLH therapy. The median age of the patients in the trial was age 1 year. The study showed that 63% of patients experienced a response and 70% were able to proceed to stem cell transplant. Common adverse events reported by patients receiving the drug in clinical trials included infections, hypertension, infusion-related reactions, low potassium, and fever.
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Texas cases of infant botulism linked to honey pacifiers from Mexico
Newsweek (11/19/18) Phifer, Donica

Health authorities in Texas are warning against the use of honey pacifiers after four babies in the state were hospitalized with infant botulism between August and October. All were given a pacifier containing honey that originated from Mexico and that might have contained a bacteria capable of producing the toxin associated with botulism. The toxin can attack babies’ organs, causing respiratory problems, paralysis, and even death. CDC advises against giving honey to children in the first year of life because they lack enough types of bacteria to keep botulism bacteria from growing and becoming toxic. Honey pacifiers are rare in the United States but can be purchased online and through specialty retailers. FDA says it is working to identify and notify the online vendor that sold the pacifiers.
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Walgreens, Humana is in preliminary talks to take stakes in each other
Wall Street Journal (11/21/18) Mattioli, Dana; Siconolfi, Michael; Cimilluca, Dana

Walgreens Boots Alliance and health insurer Humana are reportedly in preliminary discussions to take equity stakes in each other. The companies, which already have a partnership focused on serving older adults from two Walgreens locations, are having wide-ranging talks that also include the possibility of expanding that venture, according to people familiar with the matter. Community pharmacies and other health providers are looking for ways to diversify, bulk up and insulate themselves against external threats, including from Amazon.com. For Walgreens, a closer connection with Humana could replicate expected benefits of the recent CVS-Aetna merger at a much lower cost than a takeover, especially given the strong performance of Humana stock in recent years. Cross shareholdings could increase incentives for the companies to work together and make their partnership work. Older adults are heavy users of pharmacies and a focus for Humana because of its Medicare business. The partnership is part of a broader effort by Humana to move further into the business of providing direct care to its Medicare Advantage members. Last month, Walgreens said it would expand its collaboration with LabCorp, a well-established diagnostics company, with the companies opening at least 600 LabCorp patient-service centers at Walgreens stores over the next 4 years.
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HHS activates aid for uninsured Californians in need of medications lost in wildfires
HHS News Release (11/21/18)

HHS said Wednesday that uninsured residents of California’s Butte, Los Angeles, and Ventura counties are eligible for free replacements of essential medications lost or damaged by the wildfires in those counties. HHS Assistant Secretary for Preparedness and Response Robert Kadlec, MD, explained that the Emergency Prescription Assistance Program (EPAP), which is managed by HHS’ Office of the Assistant Secretary for Preparedness and Response, “provides vital assistance to people without insurance who rely upon certain prescription medicines and equipment to protect their health after disasters. I encourage citizens in impacted areas of California who qualify for this assistance to take advantage of it.” Under the program, which covers most prescription drugs, individuals needing certain prescription drugs during an emergency may obtain—at no cost to those without insurance—a 30-day supply at any EPAP participating pharmacy through December 31, 2018. The program may also be used to replace certain medical supplies or medical equipment that were damaged or lost as a direct result of the wildfires or as a secondary result of loss or damaged caused while in transit to an emergency shelter. Nationwide, more than 72,000 pharmacies participate in the program, including more than 200 in California. Pharmacies in the California can call 888-571-8182 to be added to EPAP.
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Kentucky allows pharmacies to treat influenza, strep throat patients without visits to the doctor
WKYT News (Ky.) (11/20/18) Arroyo, Emilie

A new law in Kentucky allows pharmacists to work in partnership with a prescribing physician to test for and treat certain conditions, such as influenza and strep throat. “We will check their blood pressure, temperature. We’ll do a full assessment of the patient and then we will do the testing, either a throat swab or the nose swab for the flu,” said Jennifer Baker, PharmD, of the West Knox Pharmacy. “At the most, a 20-minute visit. Which is awesome.” The law requires pharmacies to get the support of a prescribing physician and to complete a 20-hour certified training program. Few pharmacies have signed on so far, but Kentucky pharmacy officials hope that by this time next year, 20% of the state’s pharmacies will be able to offer the new services. Officials say it will help reduce urgent care and emergency room visits and save patients money and time spent in the waiting room.
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Spinal-cord stimulators cause more than 80,000 injury reports since 2008
Associated Press (11/25/18)

An Associated Press investigation found that spinal-cord stimulators account for the third-highest number of medical device injury reports to FDA, with more than 80,000 incidents flagged since 2008. Medical device companies and doctors have touted the stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief. However, patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data show. Among the 4,000 types of devices tracked by FDA, only metal hip replacements and insulin pumps have logged more injury reports. Medical device manufacturers insist spinal-cord stimulators are safe and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients. Most of these devices have been approved by FDA with little clinical testing, however, and the agency’s data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared with hip implants, which are far more plentiful. FDA said last week that it is taking new action to create “a more robust medical device safety net for patients through better data.”
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Trump administration invites health care industry to help rewrite ban on kickbacks
New York Times (11/25/18) Pear, Robert

The Trump administration has requested recommendations to relax rules that prohibit kickbacks and other payments intended to influence care for people on Medicare or Medicaid. The goal is to open pathways for doctors and hospitals to work together to improve care and save money. Health care providers are urging officials to waive or roll back the requirements of federal fraud and abuse laws so they can join forces and coordinate care, sharing cost reductions and profits in ways that would not otherwise be allowed. Current federal laws prevent insurers from rewarding Medicare patients who lose weight or take medicines as prescribed, and create legal risks for any arrangement in which a hospital pays a bonus to doctors for cutting costs or achieving clinical goals. The existing rules are aimed at preventing improper influence over choices of doctors, hospitals, and prescription drugs for Medicare and Medicaid beneficiaries. Health care providers can be fined if they offer financial incentives to Medicare or Medicaid patients to use their services or products. Drug companies have been found to violate the law when they give kickbacks to pharmacies in return for recommending their drugs to patients. Hospitals and drug companies are urging the Trump administration to provide broad legal protection for arrangements that promote coordinated, “value-based care.”
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Attorneys general fighting for right to regulate PBMs
Dayton Daily News (11/21/18) Wedell, Katie

Thirty-three attorneys general filed an amicus brief in the U.S. Supreme Court on Wednesday, supporting states’ rights to regulate PBMs. The brief argues that regulation of PBMs is a matter for state authority in protecting the access to and affordability of prescription drugs. “States’ experience has been that improving transparency in drug pricing requires regulation of PBMs,” the brief says. “Unlike other actors in the drug market, PBMs feature in almost all of the key transactions that drive the price of a drug. PBMs also face incentives that often do not align with patients’ interest in obtaining prescription drugs at reasonable cost.” The brief cites media reports and research studies of the PBM system that show how the companies benefit from higher list prices on drugs, limit access to certain drugs via formularies that list which drugs health plans cover, and are pushing rural and independent pharmacies out of the market. The case in question involves a 2015 law passed in Arkansas that regulated PBMs by setting standards for generic drug prices. It was challenged by the Pharmaceutical Care Management Association, which argued that the Employee Retirement Income Security Act prevents the State of Arkansas from implementing the law. Arkansas has asked the Supreme Court to hear the case.
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Expansion of the Medicare 340B payment program
Journal of the American Medical Association (11/16/18) Bach, Peter B.; Sachs, Rachel E.

The 340B program has seen a spurt in participation in recent years—growth that critics say has compromised its mission, impact, and incentives. The initiative was created in 1992 to provide a discount on outpatient medication costs for select health care institutions that, despite running on shoestring budgets, cater primarily to low-income populations. Now, however, the program is flooded with large and financially comfortable hospitals, many of which are expanding into wealthier neighborhoods with mostly insured patients instead of into underserved communities where many patients lack coverage—the program’s target demographic. In addition, the crowding has skewed prescribing patterns, with the Government Accountability Office reporting that when profits from high-cost medications increase more than profits from cheaper alternatives under 340B, prescribing patterns subsequently favor the higher-priced drugs. Because many participants do not provide a break on the drugs they dispense to lower-income charges, however, there is no direct benefit to patients. These problems notwithstanding, research suggests that the base funding mechanism of 340B is flawed and is the root cause of its troubles. It allows participating facilities to pay less for outpatient drugs but still charge insurers the full price when dispensing or administering the medications. The billions of dollars in related profits are intended to support the program’s public interest goals but have in some cases been diverted to other uses. CMS has pushed back by changing payment rules, with significant opposition from hospitals. Although it has a strong case, critics say CMS cutbacks are not necessarily the best solution.
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REACHING IMPORTANT GATEKEEPERS:  TRAINING PHARMACISTS ABOUT ELDER ABUSE 

Tatyana Gurvich, PharmD—University of California, Irvine /University of Southern California and Glendale Adventist FPRP
Bradley Williams, PharmD, CGP—University of California, Irvine /University of Southern California
Mary S. Twomey, MSW—University of California, Irvine 
Elaine A. Chen, MS—University of California, Irvine 
Laura Mosqueda, MD, FAAFP, AGSF—University of California, Irvine 

The role of pharmacists is critical in addressing elder abuse, yet they receive no training in this area.  Geropharmacist educators from UC Irvine, USC and Glendale Adventist FPRP teamed up with the UC Irvine Center of Excellence on Elder Abuse and Neglect to develop course materials for pharmacy students.  Students learn that pharmacists in any setting (in-patient, outpatient, ambulatory, and long-term care settings) may detect elder abuse.  This project sheds light on the hidden but common problem of elder mistreatment.  It helps students identify red flags of abuse and neglect and gives direction on how to proceed when mistreatment is suspected.
The hidden problem of elder abuseAs seniors become frail, they become isolated from regular interactions with their social support system.  Pharmacists may be the only non-caregiver contacts outside the home.  Pharmacists are mandated elder abuse reporters in some states, and always have professional responsibility to protect the public welfare.When refills are requested pharmacists have an excellent, and often missed opportunity, to interact with patients and spot risk factors, which may indicate abuse.  Medications become instruments of abuse when they are used to over or under medicate patients, withheld due to cost, or stolen. A drug regimen review can reveal such red flags. Multi-faceted curriculum for pharmacy schools To support pharmacy school instructors seeking to include elder abuse-related content in their classes, we have developed free modularized materials that can be downloaded from this website.  These modules can be incorporated into various classes.  Training materials include:Learning objectivesPowerpoint slides HandoutsMultiple-choice test questionsKey resources for further informationScenarios (written and on video)

These modules are available free of charge.  We only ask that you please give us feedback on these materials, using a very short online survey

AB 40 Update: To depict the new requirements for mandatory reporting of suspected physical abuse in a long-term care facility, the California Long-Term Care Ombudsman Association and the State Long-Term Care Ombudsman have created a helpful flow chart (PDF). For additional training information about AB 40 (effective 01/01/13 and reflected in W & I Code 15610.67) please visit www.cltcoa.org.  We are in the process of incorporating these changes into the slide sets for “An Introduction to Elder Abuse,” “Elder Abuse and the Law,” and “Elder Abuse: A Pharmacist’s Role.” In the mean time, please download and use the handy flow chart (PDF).

“AN INTRODUCTION TO ELDER ABUSE FOR PHARMACISTS”

(10-15 min) This brief module is appropriate for first- or second-year students.  An Introduction to Elder Abuse is presented in the Self-Care Class at USC for second-year students. 

“INCREASING PHARMACIST AWARENESS OF ELDER ABUSE AND THE LAW”

(1 hr) is presented in the Law Class at USC for second-year students.  It addresses laws pertaining to reporting of abuse in didactic and case-based formats.  Special thanks to Fred G. Weissman, JD, Pharm D.

“ELDER ABUSE: A PHARMACIST’S ROLE”

(1 hr) ipresented in the Special Population Module in Therapeutics at USC for third-year students.This module would also be appropriate for community pharmacists.  Special thanks to Leslie Vitin, Pharm D.

“PHARMACY PRACTICE EXPERIENCES THROUGH ELDER ABUSE EDUCATION”

This brief guide includes ideas for providing Introductory Pharmacy Practice Experiences and Geriatrics Ambulatory Care rotation activities.  These include Multi-Disciplinary Teams of professionals addressing cases of abuse and neglect and visits with Community Agencies, such as Adult Protective Services, Long-term Care Ombudsman, and Law Enforcement.

“TRAINING SCENARIOS”

These case examples were designed to aid in recognition of elder mistreatment and to spark discussion.

  • Written scenarios (MS Word) including the three below and additional clinical and nursing-home based case examples

Video-based scenarios


Film production by Alec Contestabile and Ngoc Ho

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