FDA makes new MedWatch tool available: The Food and Drug Administration (FDA) now has a web-based tool to improve use of MedWatch adverse event reporting forms. MedWatchLearn allows health professionals, health professions students and consumers to practice completing the MedWatch form. The intent of this practice is to build greater confidence and increase the likelihood that the health professional, student or consumer will complete the form EVERYTIME they identify a problem with an FDA approved drug or medical device.
In their published work evaluating the current state of pharmacy education regarding the FDA, including student knowledge and use of adverse event reporting, Holdford and colleagues indicate "Areas perceived to be in need of improvement include educating pharmacy students about the Food and Drug Administration's (FDA's) role in product safety, how to work with the FDA in post-marketing surveillance and other FDA safety initiatives, teaching students methods to improve safety, and educating students to practice in interprofessional teams." The gap in student exposure to and comfort with FDA adverse event reporting was substantiated by Gavaza and colleagues, who concluded: "Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs." The new MedWatchLearn tool is the FDA’s contribution to shrinking this knowledge and comfort gap among health professions students.
HP2020 up on website: AACP was successful in pursuing a new objective in the Education and Community-Based Programs (ECBP) goals of Healthy People 2020. ECBP 17 states: "Increase the inclusion of core clinical prevention and population health content in Doctor of Pharmacy (PharmD) granting colleges and schools of pharmacy."
Pharmacy education joins its health professions colleagues that were included in a similar HP2010 objective and continued into HP2020. AACP members contribute to the data related to this objective through participation in the institutional research surveys.
What IS sequestration doing to us?: Most of us know that federal program funding is undergoing a great contraction. Some of us may already be feeling the impact of this contraction. Most of us will likely feel the impact in the near future as federal dollars once used to support local and state programs begin to dry up. The variable impact of this funding reduction makes it difficult to build public support for seeking an end to the very real threats to programs and services we depend on and need to remain a productive, economically-viable nation. In a new video, created by NDD United, you can quickly see what this funding reduction called the sequester, is and will mean to each of us over the coming years. Because of its simplicity this is a great way to help others understand and appreciate just what the call for reduced government without a public discussion of what gets reduced means to our immediate and long-term individual, community, state and national priorities and needs.
Another good infographic was developed by the Leonard Jason and colleagues and posted on the Oxford Press blog site: How sequesterable are you?
As a continued request, AACP seeks your stories about what reduced federal funding means to you:
1. How has your program, research, community been impacted by the sequester?
2. If you are uncertain if your programs, research or community are being impacted specifically by the sequester, are they being impacted by reduced federal funding? If so, what is that impact?
3. What would you be able to accomplish if those lost federal funds were restored or you received additional federal funding?
Send your input to Will Lang at firstname.lastname@example.org!!!
Better yet…share this video and your stories with your member of Congress during their visits back to your district or state during the 4th of July break (first week of July) or the August recess (month of August). Contact Will Lang email@example.com if you would like assistance in preparing for a visit with you member back in your state or district.
NIH and the sequester: On Monday the National Institutes of Health (NIH) released information describing the impact of the sequester on NIH programs. The impact includes:
"Delay in medical progress:
-- Medical breakthroughs do not happen overnight. In almost all instances, breakthrough discoveries result from years of incremental research to understand how disease starts and progresses.
-- Even after the cause and potential drug target of a disease is discovered, it takes on average 13 years and $1 billion to develop a treatment for that target.
-- Therefore, cuts to research are delaying progress in medical breakthroughs, including: development of better cancer drugs that zero in on a tumor with fewer side effects
-- research on a universal flu vaccine that could fight every strain of influenza without needing a yearly shot.
-- prevention of debilitating chronic conditions that are costly to society and delay development of more effective treatments for common and rare diseases affecting millions of Americans.
-- Risk to scientific workforce:
-- NIH drives job creation and economic growth. NIH research funding directly supports hundreds of thousands of American jobs and serves as a foundation for the medical innovation sector, which employs 1 million U.S. citizens. Cuts to NIH funding will have an economic impact in communities
throughout the U.S. For every six applications submitted to the NIH, only one will be funded. Sequestration is reducing the overall funding available for grants."
Measure outcomes to improve performance: Reorganizing our volume-based, fee-for-service health system to a value-based, pay-for performance system is a huge challenge. The development of performance measures is a leading approach for getting that change to happen. Currently most performance measures are process-based. The Urban Institute, supported by the Robert Wood Johnson Foundation, recommends that we quickly move from process to outcome performance measures. "Achieving the Potential of Health Care Performance Measures," includes seven recommendations:
1. Decisively move from measuring processes to outcomes;
2. Use quality measures strategically, adopting other quality improvement approaches where measures fall short;
3. Measure quality at the level of the organization, rather than the clinician;
4. Measure patient experience with care and patient-reported outcomes as ends in themselves;
5. Use measurement to promote the concept of the rapid-learning health care system;
6. Invest in the "basic science" of measurement development and applications, including an emphasis on anticipating and preventing unintended adverse consequences; and
7. Task a single entity with defining standards for measuring and reporting quality and cost data, similar to the role the SEC serves for the reporting of corporate financial data, to improve the validity and comparability of publicly-reported quality data.
The report recommendations provide opportunity for pharmacy faculty to actively engage in the development and evaluation of outcomes measure. It is encouraging to see the authors see the organization as the appropriate level to address quality of outcomes. This may be one of the mechanisms for quickly aligning payment policy with performance as the "team" and not individual providers be responsible for meeting performance measures that lead to payment.
Federal employees able to attend meetings: The Office of Management and Budget (OMB) has released a "Controller Alert" that restates the expectations for compliance with conferences and meeting attendance costs. The good news is that this Alert clarifies that federal employees are, within certain parameters, able to participate in external meetings:
"Several agencies rely on meetings with industry and academic colleagues to drive innovation and ensure continued advancement in related fields. Each agency needs to focus any conference and travel spending on mission-critical activities and to ensure any related spending is an effective and efficient use of Federal funds."
But, the impact of the sequester makes attendance, even when justified, less than assured:
"On March 1, 2013, the President ordered a sequestration of non-exempt budgetary resources for FY 2013 pursuant to section 251A of BBEDCA. The resulting reductions in budgetary resources have led agencies to reduce important agency activities. These reductions will be a continued constraint on the ability of each agency to carry out important functions, including reduced Government participation in mission-supporting conferences and travel. Consequently, while an agency should not interpret the recent M-12-12 and related guidance as a moratorium on all conference events, agencies and related stakeholders should anticipate a continued reduction in conference and travel activity for the duration of the sequestration order."
OMB gives agencies FY15 guidance: Even though the FY14 funding levels for federal agencies remains mired in the uncertainty of the appropriations process, the Office of Management and Budget (OMB) provided federal agencies with guidance for the development of their FY15 budgets. The May 29th guidance presents another bleak picture for future federal funding. The reality for federal agencies is NOT good:
"Your 2015 budget submission to OMB should reflect a 5 percent reduction below the net discretionary total provided for your agency for 2015 in the 2014 Budget. Your budget submission should also include additional reductions that would bring your overall submission to a level that is 1 0 percent below the net discretionary total provided for your agency for 2015 in the 2014 Budget."
Keeping up with MOOCs: Massive open online courses (MOOC) continue to trend upward as the latest love-hate relationship in higher education. Given the many viewpoints regarding the value of MOOCs it is hard to get a clear picture of what that value might be to you as an individual faculty member, to your students, your institution or to higher education as a whole. To help you gain a better understanding of the pros and cons Inside Higher Education has complied a number of articles about MOOCs and an archived webinar on the subject into the MOOC Moment.
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Founded in 1900, the American Association of Colleges of Pharmacy (AACP) is a national organization representing the interests of pharmacy education and educators. Comprising all accredited colleges and schools of pharmacy including more than 6,400 faculty, 57,000 students enrolled in professional programs and 5,700 individuals pursuing graduate study, AACP is committed to excellence in pharmacy education.