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Texas Hospital Pharmacy News - August 6, 2012
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In This Issue August 6, 2012 Vo. 41, No. 29 On This Date On August 6, 1890 the electric chair was used for the first time to execute a convicted murderer. In 1945, the Enola Gay dropped the world's first atomic bomb over the city of Hiroshima, Japan. In 1926, Gertrude Ederle became the first American woman to swim the English Channel. In 1965 the album "Help!" by the Beatles was released. In 2009, Sonia Sotomayor was confirmed as the first Hispanic Supreme Court justice. Today's Birthdays: Dutch Shultz (1902-1935, gangster); Lucille Ball (1911-1989, actress/comedian); Andy Warhol (1928-1987, artist). Today's Trivia: Lucille Ball married a Cuban bandleader and the couple went on to star in an early TV sitcom about married life. 1. What was her husband's real name and what was his stage name? 2. What was the name of the original TV series? Practice & Profession Are You Still in Touch with Your Team? As organizations grow, the distance between
managers and workers inevitably increases, writes Monica Diaz. To stay in touch with
your team, it's important to actively cultivate honest conversations and candid exchanges with those who report to you. "It is up to the leader to create a context in which this conversation becomes possible, to make sure that communication remains open and truthful," she writes on SmartBrief/SmartBlog on Leadership. New Drugs & Devices FDA Approves Med Adherence Device. FDA has approved tiny digestible microchips that can be added to oral medication dosage forms to monitor whether patients are taking their medications, according to Medical Xpress. Proteus Digital Health plans to market the chips to drug manufacturers. The chips are about the size of a grain of sand and are made of copper, magnesium and silicon. They react with stomach juices and send a signal to a skin patch, which then relays it to a smartphone and then on to the prescriber's officer. The data the chips provide won't indicate how well the medications are absorbed or whether they are having their intended effect, but could be useful in monitoring compliance with long-term or maintenance therapy. In a recent test of 76,000 urine screens conducted by Quest Diagnostics, 63% of the patients tested did not take their medications as directed. Recalls & Warnings Recall of Benzalkonium Chloride Antiseptic Wipes. Dukal Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for Dukal by Jianerkang Medical Dressing Co. This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. Use of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients. All customers are advised to discontinue use of products identified in this recall immediately, and dispose of the product. See the Press Release for a listing of lot numbers affected by this recall. Respironics Trilogy Ventilators Class 1 Recall. FDA has called for a Class 1 recall of certain models of Respironics' Trilogy ventilators due to defective power supply components that may cause unexpected cessation of function, thereby stopping ventilation of the patient. There may also be failure of the ventilator alarm to sound. Affected Model/Catalog Numbers are 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151. Arrow International Multi-Lumen Venous Catherization Set, Class 1 Recall. The device's labeling erroneously states that the product "contains no medication," however; the device contains chlorhexidine and silver sulfadiazine. Additionally, the product's label is missing the appropriate chlorhexidine contraindication. If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, there is the potential for an allergic reaction presenting as a delayed rash, hives or potentially an immediate Type 1, IgE mediated anaphylaxis (loss of blood pressure, bronchospasm and vascular collapse). The product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine. CareFusion Alaris PC Unit Class 1 Recall. FDA has issued a Class I Recall of the Alaris PC unit, model 8015. A component on the PC unit power supply board is causing an error code (120.4630): "System Error" or "Missing Battery Error" to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient. B. Braun Infusomat Infusion System Class 1 Recall. FDA has called for a Class I Recall of the B. Braun Infusomat Space Infusion System, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.Affected pumps were distributed from November 6, 2008, to December 29, 2011. State, National & International Ebola Outbreak Kills 14. The world's first major outbreak of Ebola hemorrhagic fever since 2009 has killed at least 14 of 20 people infected in a remote area of midwestern Uganda. International health officials rushed to respond to the outbreak, which began in early July, but was only recently identified as the Ebola virus. The outbreak started and spread first within one family. Initially, locals believed the illness was a result of an attack of evil spirits and took the patients to a Christian religious shrine for prayers, where the first 2 victims died. Some of those victims came into contact with many people, including churchgoers, according to reports. The World Health Organization said that the outbreak was under control by Saturday, and announced they had a list of 176 individuals who had been in contact with those who were infected. Ebola is rare, but extremely deadly. The most lethal strain has killed as many as 89% of those it infected. The current outbreak was identified as caused by a less virulent strain, Ebola Sudan. 438 Died in Indian Clinical Trials Last Year. According to the Business Standard, 438 people died in clinical trials conducted in India last year, a number that some attribute to lax regulations in the country. The number is a decline from the 668 deaths in 2010. The report noted that manufacturers rarely pay compensation to the families of patients killed in trials, having done so only in 22 cases in 2010. There are no minimum clinical standards for trials in India, and the only requirement is medical supervision, meaning any doctor can administer a legal trial in a private clinic. 5% of Americans Spend 50% of Healthcare Dollars. A new issue brief from the National Institute of Health Care Management shows that, in 2009, half of the population (about 150 million people) spent an average of just $236 per person on health care, totaling about $36 billion. However, about 15 million people, or about 5% of the population, spent $623 billion, or about half of all personal health care expenditures, (about $41,000 per patient). Considering just the top 1% of healthcare "spenders" the average was over $90,000 per patient per year. These 3 million people accounted for over 20% of total healthcare costs and usually were dealing with illnesses such as heart disease, diabetes, cancer or dementia. The study showed that the vast majority of those with the highest costs were older and often had multiple chronic conditions, many of which were associated with obesity. While people 65 and older and eligible for Medicare made up just 13% of the population, they made up 40% of the high spending group. Massachusetts Passes Health Care Spending Cap Law. The Massachusetts legislature has passed a first-of-its-kind law to limit healthcare costs, with the goal of saving the state $200 billion over the next 15 years. Cost-control measures within the bill include a tax on insurers that would be earmarked for preventive care, and encouraging the creation of accountable care organizations. The law will require hospitals and doctors to reduce their rate of cost growth by about half, with cost increases being limited to 3.6% per year. The legislation does not include punishment if the spending targets are not met, but a new state board could require hospitals that don't meet the goals to produce a plan of action to come into compliance. The insurer tax also provides funding for small community hospitals and will help fund a program that will provide assistance to small providers to buy into electronic health records systems. Under the
state's universal healthcare law enacted in 2006, 98.1% of the state's residents are insured, the highest rate in the nation. However, the original legislation did not have controls on costs, which have been steadily increasing. Getting Down to Brass Tacks. Retiring Texas Health and Human Services Commissioner Tom Suehs appeared before a Texas House committee last month and clearly laid out the dilemma facing the legislature and citizens of the State. "We're not debating whether somebody gets health care in this state, we're debating how you pay for it," Suehs said. "Either you are going to pay for it through the Medicaid program or private insurance through subsidies or you're going to pay for it through local tax dollars." Citing the estimated $17.3 billion in annual costs for hospitals to treat the uninsured, Suehs noted that the State opposes expanding Medicaid because the system is "broken" and already consumes too much of the State budget (25%). It pays for the care of one in four children, more than half of childbirths and half of nursing home costs. As the Houston Chronicle pointed out in its in-depth coverage of the issue, the burden of paying for the uninsureds' health care falls largely on county residents whose property taxes support safety-net public institutions. One example given was Harris County Hospital District, which spent $675 million last year caring for the uninsured. Industry Matters Generic Drugs Save $. According to an analysis conducted by IMS Health, using government data, and released by the Generic Pharmaceutical Association (GPhA), generic drugs have saved the healthcare system more than $1 trillion over the last decade. The industry is pushing for expanded use of generics in Medicare and Medicaid. According to IMS, generics saved the healthcare system $1.7 trillion between 2002 and 2012 and the savings are growing. Generics produced $193 billion in 2011, a 20% increase over the previous year. Speaking of . . . What's Next? According to the Chicago Tribune, dozens of brand name drugs will lose their patent status in the next two years. Among the products that will be available in generic form in 2012 are Symbyax, Geodon, Lexapro, Seroquel, Avandia, Avandamet, Avandaryl, Avapro, Avalide, Provigil, Plavix, Viramune, Lescol/Lescol XL, Tricor, Clarinex/Clarinex D, Singulair, Actos, Xopenex, Revatio, Diovan/Diovan HCT, Detrol, Lidoderm, Atacand/Atacand HCT, Evoxac, Maxalt/Maxalt MLT, and Actoplus Met. In 2013, the following will become available generically: Opana ER, Zometa, Valcyte, Zomig, Fosamax Plus D, Rilutek, Temodar, Cerezyme, Niaspan, Advicor, AcipHex, Vivelle-DOT, and Cymbalta. McKesson Pays Drug Pricing Settlement. McKesson Corp. will pay $151 million to 29 states over allegations that the company artificially raised Medicaid drug prices. According to the case, McKesson deliberately drove up the prices of some 1,400 brand name drugs from 2001 to 2009. McKesson has denied wrongdoing and a company spokesman said the most recent lawsuit lacked merit. The allegation centers on the method that Medicaid programs used to calculate pharmacy reimbursements, based on Average Wholesale Price (AWP) that were published by First DataBank, Inc., which used McKesson as its sole source for the data. Government officials claim McKesson deliberately reported higher pricing to Frist DataBank. Texas will share in the fine. TSHP/ASHP/Local Chapters Beverly L. Black, MHSA, CAE, has been named as Director of ASHPs Affiliate Relations Division, effective August 1. She replaces Hannah Vanderpool, who had recently been promoted to ASHP Vice President, Office of Member Relations. Beverly, a frequent participant in TSHP Annual Seminars, has been with ASHP for 21 years, and has most recently been serving as Senior Manager of Affiliate Relations Division. ASHP is currently recruiting for a new Senior Manager of Affiliate Relations to fill the position vacated by Beverly.
Davis Postpones Retirement. TSHP Executive Director Paul F. Davis, who had previously announced his intention to retire from association management at the conclusion of his current employment contract with TSHP in June, 2013, recently met with the TSHP Executive Committee and requested the opportunity to postpone the retirement. "I'm not ready for the rocking chair, and there are still issues we need to address within TSHP to assure it continues as the leading state society of health system pharmacists in the country," Davis said. "We're glad Paul is willing to stay on for another year or two," President Brian Cohen said, "so that we can continue to use his experience and knowledge to continue to grow TSHP." The TSHP Council on Organizational Affairs has drafted proposed amendments to the TSHP Bylaws that would modify the composition of the Board of Directors and reduce dues for new practitioner members for a longer period of time. The TSHP Board is currently composed of the 5 statewide elected officers (President, Immediate Past President, President-Elect, Secretary and Treasurer) plus the President and President- Elect of each TSHP local chapter. As the number of local chapters in recent years has grown from 8 to 12, the size of the voting membership of the Board has grown to 29 individuals. With the 2 ex-officio officers-elect, 5 Section chairs and 6 Council chairs who currently serve as non-voting but invited members of the Board, it is possible to have a Board meeting consisting of over 42 individuals. It has also become common for local chapters to only send one of their officers to Board meetings, often making it difficult to obtain a quorum for voting purposes. The proposal would continue local chapter representation through the President of each local as a voting member of the Board and add each Section's chair as a voting member of the Board (which will add an industry rep, technician, student, new practitioner and pharmacy management member to the Board). The Sections, which represent segments of the TSHP membership and support base, do not have a vote in Board decisions at the present time, but represent over 1/2 of the TSHP membership and more than 1/2 of the Society's income. Additionally, the amendments would extend from the current 3 years to 5 years the period of time for which new practitioner members would pay reduced membership dues. The proposal was discussed by the TSHP Board of Directors on July 14, with the request that the changes be considered by the local chapters prior to the October meeting of the Board, at which time further action is anticipated. For informatation, contact your local chapter president. People & Places
A recent Mediterranean cruise brought four long-time friends together for a reunion. (Left to right) Helen Haynes, Stacy Taylor, Traci Metting and Sarah Lake-Wallace savored Greece and the surround areas. All have served in a variety of positions with TSHP and the TSHP R&E Foundation.
TSHP Member Shawna Thomas Nunez was recently named Texas Tech University Health Science Center School of Pharmacy Dean's Student Leadership Award recipient. Diagnosed with stage IIIB breast cancer in January 2010, she graduated in May 2012, completing her degree requirements on time despite undergoing 8 rounds of chemotherapy and enduring a radical double mastectomy with reconstruction. TTUHSC Associate Professor Rebecca Sleeper Irons, who nominated Nunez for the
honor, said "her strength of character and determination is amazing. She has stayed positive and cheerful, and I don't know how she has managed to never let the stress show." Shawna has been an active member of the TTUHSC Student Society of Health-System Pharmacists, the APhA student association, Lubbock Pharmacy Club and Phil Lambda Sigma.
Educational Opportunities
The University of Texas College of Pharmacy has announced an Immunization Update for September 14, 2012 on its Austin Campus. Scheduled for 6:00 to 9:30 PM, the program is designed for pharmacists who are currently certified to administer immunizations and vaccinations, and who need to obtain their TSBP-required 3 hours of immunization-focused CPE to maintain their certification. The registration is limited to 75 individuals. The course will be delivered by UT faculty who have extensive experience with IV sterile compounding education and training. The program will also feature a member of the Board of Pharmacy, who will highlight recent changes to TSBP rules and provide the TSBP perspective during a Q&A panel presentation. To register, follow this link: http://www.utexas.edu/pharmacy/ce/iv_registration.html Research Down Syndrome Developments. New studies are leading to hope of finding a medication to improve the intellectual abilities of people with Down syndrome. One study published in Translational Psychiatry is the first ever to show that a drug might improve the verbal memory of people with the disorder. While the benefits appeared modest and the study was small, researchers called it a major development after more than a decade of research in mice. Namenda, which is approved for treating Alzheimer's Disease, showed in a 2007 study of mice with the genetic equivalent of Down syndrome that it almost entirely normalized their ability to learn and remember. The human trials were far less striking, with only one patient in 14 showing statistically significant improvement. However, it was the first time that any research showed any improvement in the condition, and work is beginning on organizing a larger study of the drug. Antioxidants May Limit Pancreatic Cancer Risk. The risk of pancreatic cancer declined significantly as intake of antioxidants increased among participants in a large case-controlled study. The magnitude of risk reduction varied by the quantity and types of antioxidants, but reached a maximum of 67% in people who had the greatest intake of vitamins C and E and selenium. "The results support measuring antioxidants in studies investigating the etiology of pancreatic cancer," Andrew R. Hart MD of the University of East Anglia in Norwich, and co-authors wrote in conclusion in an article published online in Gut. The study involved 23,658 participants in the European Prospective Investigation of Cancer (EPIC) Norfolk Study, which spanned the years of 1993 to 1997.
BMS Halts Hep C Drug Study. Bristol-Myers Squibb has stopped a mid-stage study of an experimental hepatitis C drug. One of 30 participants in the Phase IIb trail suffered heart failure after taking a 200 mg dose of BMS-986094. The drug, obtained from Inhibitex as part of a buyout, is a nucleotide polymerase inhibitor. Researchers are attempting to determine if the death was caused by the drug. Spray-on Skin In Wound Care. A new form of wound care is emerging as a viable alternative to standard treatment of venous leg ulcers with infections. A spray-applied cell therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts has been shown to improve healing over standard care. The mean reduction in wound area at 12 weeks ranged for 8% to 16% greater with the mix of keratinocytes and fibroblasts versus placebo, according to researchers in a study published in The Lancet. The study was supported by Healthpoint Biotherapeutics, which developed the spray-on skin compound and was reported by MedPage Today. Answer to Today's Trivia 1. Lucille Ball married Desi Arnaz, who she met while filming "Too Many Girls" in 1940. 2. Despite concerns of network executives, Lucy and Desi were cast as husband and wife in the "I Love Lucy" TV series in which they played Lucy and Ricky Ricardo, from 1951 to 1957.
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