STRATEGIC PLAN - ASPE - U.S. Department of Health and Human ...

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CHAPTER 2: Health carehow FDA uncovers and communicates importantdrug safety issues. For example, FDA will focus onimproving the safety of drugs on the market in partthrough its plans to modernize the Adverse EventReporting System (AERS) and establish “AERS II” asthe primary source for drug product adverse eventdata. These resources also will allow FDA to augmentAERS data and further its efforts with CMS to obtainaccess to valuable drug safety information housed inCMS population-based databases. This collaborationwith CMS will be integrated with the Sentinel System,a seamless platform for gathering and evaluatinginformation about adverse events related to the use ofmedical products. This integration will enable FDA togather more information from the point of care aboutpotential safety problems and will provide a frameworkfor turning these raw data into useful knowledge aboutthe safe use of medical products.In order to improve current processes and systemsfor collection of adverse events and errors, FDA isdeveloping MedWatch Plus. This program will providea single internet portal for anyone needing to reportan adverse event resulting from an FDA regulatedproduct, including product complaint reporting. Thisinitiative will improve the collection and processingof adverse event information for all FDA regulatedproducts. The user-friendly electronic submissioncapability will facilitate submission of adverse eventsreports to better allow FDA to efficiently and effectivelyuse the information to promote and protect publichealth. Through these modernization efforts, FDAwill continue to ensure that the medical products itregulates are the safest in the world.OPHS coordinates vaccine safety activities amongHHS agencies which conduct a broad range ofactivities aimed at ensuring the safety of vaccines.NIH conducts and funds basic research that leads tothe development of vaccines with a major emphasis onsafety. FDA has statutory responsibility for licensingvaccines. Additionally, the FDA coadministers theVaccine Adverse Event Reporting System (VAERS),a passive surveillance system, with CDC. CDC alsoconducts active surveillance of vaccine associatedadverse events through the Brighton Collaboration,and examines vaccine adverse events on the practicelevel through Clinical Immunization Safety Assessment(CISA) centers. HRSA compensates individualswho may have been injured by vaccines through theVaccine Injury Compensation Program (VICP). TheFederal government has a heightened responsibilityto ensure that vaccines are optimally safe as vaccinesare recommended for nearly ever child in the U.S. andchildren are required by state laws to receive vaccinesin order to enter school. OPHS is coordinating aninteragency strategic plan to enhance HHS vaccinesafety activities. Vaccine safety activities will beenhanced in the areas of research and development,post-licensure surveillance, and risk communication.Generic Drugs. Part of FDA’s mission is to make surethat the generic drugs approved for use in the UnitedStates are just as safe and effective as the brand-nameversions of the drugs. Generic drugs can be very helpfulfor patients because their price is typically much lower:For the average price of a brand-name prescriptiondrug that is $72, the average price of a generic versionis about $17. xiii This is an especially important sourceof drug savings at this time, because a growing numberof important brand-name medications—more than 200in the next few years—are coming off patent, pavingthe way for the development of generic versions. FDA’snew final regulation to improve how and when genericdrugs can compete with brand-name drugs will lead tosaving billions of dollars in drug costs each year.Health DisparitiesThe Racial and Ethnic Health Disparities Outreach jointplanning effort focuses on outreach to raise awarenessamong minority communities about major healthrisks prevalent in their specific populations and toprovide access to information on how to reduce theserisks. AoA, CDC, IHS, NIH, OCR, and OPHS partnerwith media, State and local health departments, Stateand area agencies on aging, and tribal governments onthis effort. Additional information on HHS’s efforts onthis topic can be found later in this chapter in In theSpotlight: Reducing Health Disparities.44 HHS Strategic Plan FY 2007-2012
CHAPTER 2: Health careStrategic Objective 1.4Recruit, develop, and retain a competenthealth care workforce.In the coming years, the Nation faces shortages of criticalhealth care workers, including nurses and long-termcare providers. In addition, all health care workerswill need to be flexible and responsive enough to acton new challenges and maximize the potential of newtechnologies. In addition to strategies to develop itsown workforce, HHS is committed to helping the fieldrecruit and retain, as well as train, develop, and support,a competent professional and paraprofessional healthcare workforce. Among the operating and staff divisionscontributing to the achievement of this objective areAoA, ASPE, CMS, HRSA, IHS, OPHS, and SAMHSA.HHS, in the health care programs it operates, faces thesame recruitment and retention challenges encounteredby health care providers nationwide. The first performanceindicator measures HHS’s success in meeting its goal torecruit and retain the Commissioned Corps membersneeded to provide ongoing health care. The secondmeasures the Corps’ readiness to rapidly respond tomedical emergencies and urgent public health needs.Recruitment /Retention EffortsCommissioned Corps. The mission of theCommissioned Corps of the United States Public HealthService (USPHS; Commissioned Corps) is protecting,promoting, and advancing the health and safety ofthe Nation. The Commissioned Corps achieves itsmission through rapid and effective response to publichealth needs, leadership and excellence in publichealth practices, and the advancement of public healthscience. As one of the seven Uniformed Services of theUnited States, the Commissioned Corps is a specializedcareer system designed to attract, develop, and retainhealth professionals who may be assigned to Federal,State, or local agencies or international organizations.The Commissioned Corps will continue to offer twoexcellent opportunities for students through the highlycompetitive Junior Commissioned Officer Student Trainingand Extern Program and Senior Commissioned OfficerStudent Training and Extern Program.HHS Strategic Plan FY 2007-201245
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