April 2012 GSHP Newsletter

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April 2012 GSHP Newsletter

  1. 1. CMS:Preview/Send Your Account GSHP News Content Newsletter Design Preview/Send News Log-Out Preview Production Calendar Newsletter Archive You can preview your newsletter as many times as you like. When you are ready to "publish", enter an E-mail address in the box below, click on the checkbox and then click on the "publish newsletter" button. deliver to Publish/E-mail Newsletter   multiple addresses? | About GSHP | ASHP | How You Can Join | Contact Us |   April 2012 Announcements GSHP Membership Dues GSHP Newsletter Click here to pay your Welcome to the GSHP Newsletter. We hope you will enjoy the new revised GSHP membership dues newsletter filled with Georgia and National news and information. web link In this issue are: GSHP 2012 Summer meeting, July 20-22 About GSHP 2012 Legislative Session Wrap-Up Get more out of your GSHP membership web link Georgia Society of Health- Headlines System Pharmacists (GSHP) is a professional society of GSHP News pharmacists and related personnel practicing in GSHP 2012 Summer meeting, July 20-22 organized healthcare 2012 Legislative Session Wrap-Up settings. Get the Most Out of Your GSHP Membership Mission Statement ASHP News Helping our members Renewed Focus on Tuberculosis Holds Promise for New Treatments become better practitioners. FDA Mulls Expanded Universe of Nonprescription Drugs Motto ASHP and Other Concerned Organizations Call for Changes to Draft Drug Bringing pharmacy practice Shortages Bill into focus. BPS Calls for Taskforce Members for New Specialties Pharmacy News Hospitals Scramble on the Front Lines of Drug Shortages Georgia Society of Health- System Pharmacists FDA Approves Peginesatide to Treat Anemia in Adult Patients on Dialysis 3015 Shannon Lakes North FDA, IOM Point to Need to Ramp Up Development of Abuse-Resistant Suite 303 and Novel Nonopioid Pain Medications Tallahassee, FL 32309 Percentage of Child Deaths by Meds Poisoning Rising               (800) 913-4747       Citalopram Hydrobromide - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms • e-mail link NY Leaders Negotiate Prescribed Drugs Restrictions • web link Kentucky Joins Program to Share Prescription Drug Dispensing Data AMA, Pharmacist Testify at FDA Hearing on Innovative Technologies White House and the F.D.A. Often at Odds California, Vermont Consider Tougher Vaccine-Exemption Ruleshttp://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  2. 2. CMS:Preview/Send GSHP News GSHP 2012 Summer meeting, July 20-22 About ASHP ASHP is a 35,000-member national professional   association that represents pharmacists who practice in   hospitals, health maintenance organizations, Amelia Island Plantation long-term care facilities, home care, and other   components of health care Amelia Island Plantation Video systems. ASHP is the only national organization of hospital and health-system Take a tour of Fernandina Beach (video) pharmacists and has a long history of improving medication use and enhancing patient safety. Summer meeting online registration American Society of Comments from last years meeting Health-System Pharmacists 7272 Wisconsin Avenue GSHP has a superior program! Well worth traveling to attend. Have Bethesda, MD 20814 attended state meetings elsewhere, and Georgia rocks! Very relevant               301-657-3000       & applicable information, excellent speakers & fun, too.  • e-mail link • web link I thought the meeting was fantastic...the right mix of learning and fun! Calendar Great facility, friendly GSHP facilitators, wonderful learning and collaborative environment 2012 Summer Meeting and Exhibition [ASHP] Beautiful location, very good content, will attend again next year  6/09/12 - 6/13/12 The ASHP 2012 Summer AGENDA as of 4/18/2012, subject to revisions Meeting is your chance to take part in four fulfilling days of intense intellectual FRIDAY (6.5 hours) stimulation, in-depth education, and hands-on exploration. Join your peers 10:00am – 11:00am Parenteral Nutrition in Baltimore for this unique experience designed 11:00am – 11:15am BREAK expressly for current and future pharmacy leaders in hospitals and health 11:15am – 12:45pm Multiple Myeloma (Lunch provided) systems. Baltimore Convention 12:45pm – 1:00pm BREAK Center Baltimore, Maryland 1:00pm – 2:00pm TRACK A: Stroke prevention for afib web link TRACK B: Neonatology GSHP Summer Meeting 7/20/12 - 7/22/12 2:00 – 2:15 pm BREAK Amelia Island Plantation, FL 2:15 – 3:15pm TRACK A: Surviving Sepsis update TRACK web link B: TBD 2012 National Residency Preceptors 3:15 – 4:15 pm Poster session Conference [ASHP] 8/16/12 - 8/18/12 4:15pm – 5:15pm Key Note Address- PPMI The National Residencyhttp://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  3. 3. CMS:Preview/Send Preceptors Conference (NRPC) is the only meeting 5:15pm – 6:15pm Open Forum: purely dedicated to pharmacy residency training. The NRPC covers 6:30pm – 8:30pm Reception/Exhibits in Exhibit Hall timely topics important to all program directors and SATURDAY (3.5 hours) preceptors of ASHP- accredited, ASHP- application submitted, and 8:00am – 9:30am TRACK A: Managing vascular newly emerging residency complications of new targeted chemotherapeutic agents training programs. This is a must-attend event for TRACK B: Informatics residency preceptors and directors who seek quality programming and 9:30am – 11:00am Exhibits/Breakfast in Exhibit Area networking opportunities with other preceptors across 11:00am – 12:00pm TRACK A: Berkley testing / Am care the country. clinic expansion TRACK B: Medication Errors Washington D.C. web link 12:00pm – 1:00pm TRACK A: New drug update: antibiotics TRACK B: Medication Errors GSHP Annual Meeting 10/19/12 - 10/21/12 Brasstown Valley Resort 12:00pm – 2:00pm Resident and Student Forum (box lunch provided) Young Harris, GA web link SUNDAY (3 hours) 2012 Midyear Meeting [ASHP] 8:00am – 9:00am Breakfast / Officer Installation 12/02/12 - 12/06/12 The 47th ASHP Midyear 9:00am – 10:30am New Anticoagulant reversal Clinical Meeting & Exhibition will be held in the exciting Las Vegas, this year. 10:30am – 12noon TRACK A: Sun, Sand, and Simplifying ASHPs Midyear Clinical Preceptor Development: A Winning Combination for Meeting is the largest gathering of pharmacists in Advancing Residency Training. TRACK B: HIV Overview the world. With its focus on improving patient care, the Room Reservations meeting is attended by more than 20,000 pharmacy professionals The 2012 Summer Meeting will be held at the Omni Amelia Island Plantation, from 86 countries. For Amelia Island, FL.  GSHP has very attractive room rates that start at $173 decades, the ASHP Midyear single/double per night for an ocean view hotel room at the Omni Amelia Clinical Meeting has Island Inn and Beach Club.  To make your reservation, click here: provided health-system pharmacy practitioners with http://www.omnihotels.com/FindAHotel/AmeliaIsland/MeetingFacilities/GSHSP a venue for updating their knowledge, networking with colleagues, enhancing their The GSHP room rate will be honored for three days prior to group arrival and skills, and learning about three days after group departure.  the latest products and technologies. The Plantation has a wide variety of rooms and villas and the link above can help you with any of them. Las Vegas, NV web link Click here for villa information, rates, etc. There is NO daily resort service fee this year.   The room rate includes: Self Parking ($10 daily value) Unlimited high speed internet access in all accommodations ($9.95 daily value) On-property Transportation ($4.00 daily value) Unlimited use of health & fitness center ($20 daily value) In Room Coffee Service ($5.00 daily service)http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  4. 4. CMS:Preview/Send Meeting Concierge & 24 Public Safety Team Local & Toll Free Phone Access Summer meeting cancellation policy A full refund will be granted for refund requests received by July 1; from July 2 through July 10, a $25 administrative fee will be deducted from the registration fee; after July 10, there will be NO refunds for cancellations.                                               http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  5. 5. CMS:Preview/Send          web link | return to headlines 2012 Legislative Session Wrap-Up 2012 Georgia General Assembly Summary of Legislation for GSHP     S.B. 288 - Immunizations; allow pharmacists to give immunizations with physicians protocol. This measure passed out of the Senate 43-7, but died in House Health and Human Services Committee.   S.B. 346 - State Board of Pharmacy; prescription drugs by mail/other common carriers. This proposition changes current state law to allow mail order from within the state with the same restrictions and patient safety precautions that Kaiser Permanente currently has. Also allows the Board of Pharmacy to develop rules to allow for a prescription to be filled at one pharmacy and sent to another pharmacy, which is commonly referred to as Central Fill. Language for the Board of Pharmacy to regulate remote entry access for hospital pharmacies was also added to the legislation. Passed out of the Senate and House and is on the Governors desk.   S.B. 370 - Controlled Substances; Schedule I and V controlled substance; "dangerous drug."  This is the annual drug update bill. It passed the Senate and House and has already been signed by the Governor into law.   S.B. 378 - Controlled Substances; changes definition of written prescriptions for dangerous drugs.  S.B. 378 allows prescriptions to be filled in Georgia that are written in other states. It also brings state law into compliance with Federal law related to drug samples. Passed the Senate 49-0 and died in the House Judiciary Non-Civil Committee.   S.B. 380 - Pharmacist and Pharmacies; change definition of security paper. This measure remedies the problemshttp://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  6. 6. CMS:Preview/Send related to prescription pads that was inadvertently created with the passage of the Prescription Drug Monitoring legislation from last year. This bill also requires licensing of pharmacies from other states that send prescriptions to Georgians.  Passed the Senate, but died on the floor of the House on the final legislative day.   S.B. 416 – Authorizes the Department of Insurance to develop exchange standards regarding electronic prior authorization drug requests with health care providers.  Allows for the national standards that are to be adopted by the National Council of Prescription Drug Programs governing electronic prior approvals of prescriptions to be the standard followed here in Georgia. Passed the Senate and House and is awaiting the Governors signature.   S.B. 417 - Pharmacists and Pharmacies; electronic transmission mechanism; provide certain requirements.   Authorizes physicians to be able to see a complete electronic version of an insurance companys drug formulary. Did not pass the Senate and is dead.   S.B. 445 - Secretary of State; create the position of director of professional licensing; provide powers, duties, and responsibilities.  This is the Secretary of States bill to streamline the process of getting professional licenses and renewals. This bill was withdrawn from General Assembly consideration on February 28, 2012 and therefore died.  However, it is a certainty that the Secretary of State will re-introduce a similar measure during next year’s General Assembly.   H.B. 729 - Revenue and taxation; Internal Revenue and Internal Revenue Code of 1986;. Clarifies that insulin is exempt from taxes like all prescription drugs in Georgia. Passed the House and Senate and is awaiting the Governors signature.   H.B. 878 - Pharmacists and pharmacies; use remote order entry for hospital pharmacies under certain conditions. This issue was ultimately added to S.B. 346.  This version of the proposal did not pass the House and is dead.   H.B. 952 - Pharmacists and pharmacies; revises certain definitions of specific opioid drugs. Current Georgia law already allows for Doctors to notate that the prescription must be “dispensed as written.” GSHP was successful in adding language to exempt hospital systems, however this measure did not pass the House and is dead.   H.B. 964 - The Pharmacy Audit Bill of Rights; recoupment pursuant to an audit under certain circumstances.  Currently when a Pharmacy Benefit Manager audits a pharmacy, they can recoup the cost of the drug for simple clerical or record keeping errors. This legislation would correct this problem. H.S. 964 did not pass the House and is dead.http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  7. 7. CMS:Preview/Send   H.B. 972 - Georgia Pain Management Clinic Act; This is the Attorney Generals legislation to continue regulating pill mills in Georgia. H.B. 972 died on the last day of the session as the House did not have time to approve the changes made by the Senate.   H.B. 1069 - Pharmacists and pharmacies; revise definition of security paper.  Similar to S.B. 380, this measure addresses the problems regarding prescription pads that were inadvertently created with the passage of the Prescription Drug Monitoring legislation from last year. It passed the House, but died on the floor of the Senate the last day.   H.B. 1124 - Pharmacists and pharmacies; prescription biologic product and biosimilar product. Seeks to limit the substitution of biologic and biosimilar products to only other biologic or biosimilar prescriptions. Did not pass the House and is dead.   H.B. 1125 - The Pharmacy Audit Bill of Rights; recoupment pursuant to an audit under certain circumstances.  Does not allow PBMs to recoup the costs of drugs in an audit if there was a technical or error such as spelling errors, etc. Did not pass the House and is dead.   H.B. 1130 - Georgia State Board of Pharmacy; administratively attached to Department of Community Health;  Moves the Board of Pharmacy out from under the Secretary of State and makes it an independent agency like the Composite Medical Board. Did not pass the House and is dead for this year.   H.B. 1149 - Physicians; administration of vaccines by pharmacists or nurses pursuant to vaccine protocol agreements; House version of SB 288 which allows pharmacists to give any immunization. Did not pass the House and is dead.       web link | return to headlines Get the Most Out of Your GSHP Membership Our goal at GSHP is to provide you with current and timely information that will help you with your practice. In addition to the GSHP website and our email blast system, we utilize three other methods for reaching out to members. Facebook GSHP has a page on Facebook. Follow us on Facebook, by clicking on the linkhttp://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  8. 8. CMS:Preview/Send below: https://www.facebook.com/pages/Georgia-Society-of-Health-System- Pharmacists/3262 61148598 LinkedIn We also have a group on LinkedIn. To join the group, http://www.linkedin.com/groups?trk=hb_side_g&gid=3699702 Text messaging service We now have the ability to send you a text message to your cellphone and would like to ask you to join in our txt messaging service. Based on current cellphone regulations, you have to opt in to this service which you can do by sending a txt from your cellphone. You will need to txt gshp to 33938 from your cellphone. Your cellphone number will not be shared with anyone and you will receive no more than 3 txt messages per month from GSHP. Remember this is an opt in service that requires you to txt GSHP to 33938. ASHP News Renewed Focus on Tuberculosis Holds Promise for New Treatments [May 1, 2012, AJHP News] Kate Traynor BETHESDA, MD 13 April 2012—FDA approved rifampin for the treatment of tuberculosis (TB) in 1971, the same year Intel Corporation invented the first microprocessor. Since then, advances in computer technology have revolutionized the way people live and work. But no additional medications have been approved by FDA for the treatment of Mycobacterium tuberculosis infection—a problem that federal officials and others want to fix. "It cant take 40 years for us to get our next drug candidates for tuberculosis developed," said Janet Woodcock, chief of FDAs Center for Drug Evaluation and Research, during a March 19 briefing in Washington, D.C., sponsored by the Critical Path to TB Drug Regimens partnership. Launched in 2010, the partnership was founded by the Bill and Melinda Gates Foundation, the Critical Path Institute, and the Global Alliance for TB Drug Development, also known as the TB Alliance. The partnership promotes innovative ways to speed the development of new TB drugs. Read More FDA Mulls Expanded Universe of Nonprescription Drugs [May 1, 2012, AJHP News] Kate Traynor BETHESDA, MD 13 April 2012—Some drugs that are now available only with a prescription may one day be obtained after consulting with a pharmacist or answering a series of questions on a computer terminal, under a new system that FDA is considering for nonprescription drug use. Described in the February 28 Federal Register, the new system would establish "conditions of safe use" for nonprescription sales of specific drugs that would, absent these conditions, require a prescription. FDA calls its outline for the expanded availability of nonprescription drugs a new paradigm for medication use. "I would like for us to have additional flexibility for nonprescription use and the ability to use circumstances and technology and incorporate those into practices," said Janet Woodcock, chief of FDAs Center for Drug Evaluation and Research, during a March 22–23 public hearing on the new paradigm.http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  9. 9. CMS:Preview/Send Read More ASHP and Other Concerned Organizations Call for Changes to Draft Drug Shortages Bill Sign-on Letter Asks Senate Working Group to Improve Pending Legislation 4/6/2012 Bethesda, Md.— The American Society of Health-System Pharmacists (ASHP), together with 22 other health care organizations representing patients, clinicians, and hospitals, sent a letter today to the Senate Committee on Health, Education, Labor and Pensions (HELP) urging improvements in draft legislation addressing the drug shortage crisis. The Senate HELP Committee is currently drafting language to help solve the drug shortage crisis as part of its work to reauthorize the Prescription Drug User Fee Act. The signers of the letter acknowledge their appreciation of the Senate’s draft legislation; however, they are urging several improvements to ensure that the goal of eliminating generic drug shortages can be accomplished. Read More BPS Calls for Taskforce Members for New Specialties 4/2/2012 The Board of Pharmacy Specialties (BPS) is accepting nominations for taskforce members in two role delineation studies, a critical step in evaluating proposed specialties. The studies will determine whether infectious diseases and cardiology pharmacy are based upon a specialized knowledge of pharmaceutical sciences, as well as specialized functions routinely performed by practitioners in these proposed specialties, according to the BPS announcement on its website. BPS took this action in response to requests submitted jointly by several organizations including ASHP, the American College of Clinical Pharmacy, and the American Pharmacists Association. The Society of Infectious Disease Pharmacists also joined the organizations in the requests for a study of infectious disease pharmacy. ASHP has been a long-time supporter of BPS and the development of sound specialty credentials, serving as a petitioner or co-petitioner on requests to recognize four of the specialties currently recognized by BPS. The deadline for volunteering for the taskforces is May 4. For more information, go to http://www.bpsweb.org/news/pr_040212.cfm. Read More Pharmacy News Hospitals Scramble on the Front Lines of Drug Shortages Washington Post (DC) (04/10/12) Sun, Lena H. The scarcity of certain drugs--including those used to anesthetize surgical patients and to alleviate pain--has been an escalating problem for several years now, finally hitting record proportions in 2011. The phaseout of older drugs for newer ones, as well as quality problems such as fungal contamination, are the primary reasons for the shortages. Manufacturing shutdowns play a role as well. "Right now, anesthesia is a big concern," points out Valerie Jensen, associate director of the Food and Drug Administrations drug-shortage program. "These drugs are absolutely in critical shortage." Hospitals have been forced to ration medications, use more expensive alternatives, and even postpone critical treatments as a result. The fallout, according to the Institute for Safe Medication Practices, has included numerous injuries--and even some deaths--as healthcare workers make errors in dosing and preparing substitutes. Some hospitals have resorted to mixing drugs themselves, for their own use. Not only is this legal, say pharmacists, it reduces the chances of a mistake. As hospital staffers struggle daily to manage shortages and avert crises, federal regulators are fast-tracking the process for some upstart firms to produce older drugs. Additionally, manufacturers are providing earlier notification when a drug is in danger of going into short supply. return to headlines FDA Approves Peginesatide to Treat Anemia in Adult Patients on Dialysishttp://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  10. 10. CMS:Preview/Send FDA.gov (03/27/12) The FDA has approved peginesatide (Omontys) for the treatment of anemia in adult dialysis patients who have chronic kidney disease (CKD). This approval decision was based on two randomized, active-controlled, open-label, multi-center clinical trials including a total of 1,608 patients with hemoglobin levels initially stabilized by ESA. These patients were assigned to receive either peginesatide or to continue their current ESA treatment. Results showed peginesatide was as safe and effective as the current treatment in maintaining hemoglobin levels. The most common adverse events observed in patients treated with peginesatide included diarrhea, vomiting, hypertension, and arthralgia. Based on this data, the drug has been approved with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data. return to headlines FDA, IOM Point to Need to Ramp Up Development of Abuse-Resistant and Novel Nonopioid Pain Medications Genetic Engineering & Biotechnology News (04/02/12) Philippidis, Alex FDA officials, including Center for Drug Evaluation and Research (CDER) director Dr. Janet Woodcock, have recently said that the development of abuse-resistant opioids and novel nonopioid pain therapies are among the agencys priorities for 2012. This announcement follows the release of the Institute of Medicines (IOM) "blueprint for action" to improve pain prevention, care, education, and research by 2015. The blueprint asks for increased coordination by government, business, and academia on these efforts. To this end, the National Institutes of Health (NIH) awarded $386 million in research grants during the 2011 fiscal year to research to aid patients with chronic pain conditions. While there are no comparable statistics for private industry, anecdotal evidence suggests there is growing interest among pharmaceutical researchers to improve abuse-resistant pain medicines. return to headlines Percentage of Child Deaths by Meds Poisoning Rising CNN Health (03/20/2012) Each day roughly about 165 young kids in the United States are seen in emergency rooms after getting into medications, according to findings revealed in a report by Safe Kids Worldwide, which unveiled a new initiative Tuesday called “Safe Storage, Safe Dosing, Safe Kids." The campaign calls on caregivers, medical personnel, pharmacists, drug makers and government groups to work to reduce accidental poisonings of children from medications. The report, which contains poisoning data from the Centers for Disease Control and Prevention and the American Association of Poison Control Centers, reveals that while overall U.S. poisoning deaths among kids plunged by half from 1979 to 2006 - the percentage of those deaths from medications – both prescription and over-the-counter products – has nearly doubled, jumping from 36% to 64%. The trend is blamed on several factors, including more available and improperly stored medications in homes. return to headlines Citalopram Hydrobromide - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms Medwatch (03/28/2012) The FDA has issued new recommendations for citalopram hydrobromide (Celexa). These recommendations advise that the drug not be used at doses greater than 40 mg per day because it may increase a patients risk of QT interval prolongation and Torsade de Pointes. The new recommendations also advise against use of citalopram in patients already at risk of QT interval prolongation, and calls for the use of doses not exceeding 20 mg in patients over 60 years of age. These new recommendations are based on postmarketing data, and results of thorough QT studies assessing the effects of doses of citalopram and its active S-isomer escitalopram (Lexapro) on the QT interval in adults. return to headlines NY Leaders Negotiate Prescribed Drugs Restrictions Wall Street Journal (04/10/12) Spokesman for New York Governor Cuomo, Attorney General Eric Schneiderman,http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  11. 11. CMS:Preview/Send and legislative leaders have confirmed that there are ongoing talks negotiating measures to control the black market in hydrocodone and other addictive painkillers. Schneiderman has been advocating for "real time" online review and reporting on each prescription written and filled for a patient by doctors and pharmacists, as it would prevent doctor shopping by addicts and dealers. The Senate has passed bills that reclassify hydrocodone into the same restricted group as oxycodone, meaning that a new prescription is required each time, and a bill that would increase the criminal penalties for those doctors and pharmacists who illegally divert prescription drugs. return to headlines Kentucky Joins Program to Share Prescription Drug Dispensing Data Surfky News Group (03/27/12) Gov. Steve Beshear announced that the Kentucky All Schedule Prescription Electronic Reporting (KASPER) program will join the Prescription Monitoring Program InterConnect (PMP InterConnect). Under the agreement, Kentucky will share and receive prescription drug dispensing data with at least 20 other states to help monitor prescription drug abuse. PMP InterConnect aids the transfer of information to other states by linking participating drug monitoring programs. Twenty states already agreed to join the Interconnect program, and more may follow. "We are very proud of the success of our KASPER program and feel it is one of the most effective tools available for tracking drug abuse, misuse, and diversion within the state of Kentucky," said Acting Cabinet for Health and Family Services Secretary Eric Friedlander. "Joining the InterConnect will dramatically strengthen our ability to monitor and detect abuse." Kentucky has the highest rate of opioid abuse in the United States, according to the Kentucky State Epidemiological Outcomes Workgroup. Prescription drug deaths in the state almost outnumber deaths attributed to motor vehicle accidents. PMP InterConnect will allow Kentucky prescribers and pharmacists to more easily identify patients with prescription drug abuse problems. return to headlines AMA, Pharmacist Testify at FDA Hearing on Innovative Technologies Modern Physician (03/22/12) Robeznieks, Andis Both pharmacists and physicians recently testified at the Food and Drug Administration hearing on using innovative technologies—such as interactive kiosks where individuals could self diagnose and self medicate for certain conditions—to expand the availability of certain drugs without a prescription. For example, Dr. Sandra Adamson Fryhofer, expressed doubts that expanding the availability of drugs available over the counter would significantly reduce patient visits to the emergency room for minor ailments. return to headlines White House and the F.D.A. Often at Odds New York Times (04/02/12) Harris, Gardiner FDA staff say that politics continues to play a role in their decisions, despite some improvements under the Obama Administration. FDA officials say that, for example, the White House intervened when the FDA considered removing from the market unapproved, pharmacist-compounded versions of KV Pharmaceuticals 17 alpha- hydroxyprogesterone caproate (17P) due to cost concerns. Officials have also indicated that politics interfered with their decisions on access to levonorgestrel (Plan B) for some adolescents. Harvard University Prof. Daniel Carpenter has raised concerns that these revelations could have a significant impact on the FDA. "In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the FDA could hurt not only consumer protection but industry profits as well," he warned. "If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, Were not going to follow FDA recommendations anymore." return to headlines California, Vermont Consider Tougher Vaccine-Exemption Rules American Medical News (04/09/12) OReilly, Kevin B. Vaccine exemptions for children with physician-verified medical contraindications area allowed in every state, while 48 states allow religious exemptions and 20http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]
  12. 12. CMS:Preview/Send states allow philosophical exemptions. In California, parents need only sign a form to opt-out of immunization requirements, but proposed legislation would require parents to get signatures from physicians, nurse practitioners, or physician assistants indicating that they have been informed of the benefits and risks of immunization. The measure is a response to outbreaks of vaccine-preventable diseases, such as pertussis, which infected more than 9,000 people and resulted in 800 hospitalizations and 10 deaths statewide in 2010. The bill is supported by the California Medical Association, whose president-elect, Dr. Paul Phinney, says: "It just makes sure parents are fully informed and make a good decision." Meanwhile, lawmakers in Vermont have proposed eliminating the personal-belief exemption. Legislation to add religious or personal-belief exemptions or make them easier to obtain is being considered in Kansas, Massachusetts, Minnesota, Mississippi, New Jersey, New York, South Dakota, and West Virginia. return to headlines © 2012 American Society of Health-System Pharmacists. News summaries © 2012 Information, Inc.    [subscribe/unsubscribe]http://www.infoinc.com/cms/preview_send.cfm?pos=4[4/30/2012 11:03:00 AM]

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