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raft TElE ANTHER\ VACCINES IS lT SAFE? DOES IT WORK] IOM released The Anthrax Vaccine: Is It Safe? Does It Work? in March 2002. in tire Waite of anthrax infections and cleatl~s that resulted fi-om bioterror- ism in fall 2001. Congress requested tire study because of concerns raised about tire safety and efficacy of tire antI~rax vaccine widen tire Department of Defense (DoD) instituter! a mandatory vaccination program in 1998. The IOM report reviewer! tire data available on tire safety, efficacy, amuck manu- facturing of tile licensecl anthrax vaccine, I<nown as Anthrax Vaccine Adsorbed (AVA). Evic: ence from studies ilk Motif I~umans and animals lee! tire committee to conclude that AVA, as licensed, is an effective vaccine to pro- tect humans against anthrax, including inI~alational antI,rax. Moreover; AVA should be effective against not only all known strains of tire organism, but also any new bioengineerec] strains. Tire committee also con- eluded, Ott tire basis of epidemiologic studies and a review of numerous case reports, float AVA is reasonably safe. Reactions to tire vaccine, and tire rates at which they occur; are comparable to those observer! witty officer vaccines regularly administered to adults. The committee fouled loo evidence tight AVA recipi- ents face act increased risk of life-tI~reatening or permanently clisabli~g adverse events immediately after receiving the vaccine. Nor clid it fink! ally convincing evidence that vaccine recipients face higher; iong-term risI<s, although data for assessing sucks effects are limited (as Alley are for all vaccines). .~.AYA' ~S I;~, IS RO C~tiVC V~C'iHO to paws humans against anthrax. I ~ - O ~ CL I ~ Cd I
INH)1?,3~s!r(:~ 711E ii CRI/~(~AL i.~S IN HE-AL7~ The committee recommenclec! that DoD continue anc! improve moni- toring efforts to detect airy adverse health effects causer! by AVA anct other vaccines, and that the procluction, testing,, ant! licensure of a new anthrax vaccine requiring fewer closes and pr oducing fewer local reactions is neeclecI. Tire Assistant Secretary of Defense for Health Affairs described the r eport as tile most extensive r eview of tile science underlying, a'~tI,rax vac- cine ant! b°°d resews for military person. Within mottles of tire report's release, DoD reintroduced its Anthrax Vaccine l~nn~unization Program, beginning wield those service members co~siclered to be at Weigher risk and essential to tile accomplisI~me~t of military missions. As part of tile civil- ian response to bioterrorism concerns, tire Department of Heath and Human Services (DHHS) alas also made efforts to stocIcpile AVA. At tire saline tine, Motif DoD and DHHS are pursuing tire development of''next generation" anthrax vaccines as urged in the IOM report. Q~v t'~ Q^~t In 1996, tire Institute of Medicine launcI~ec! a large-scale, ongoing effort focused off evaluating ant! improving the nations quality of case which is now in its theirs pleases The first please of tile IOM Quality Initiative documented tire serious and far reacI~ing nature of tire nations overall quality problen~ inclucling tile pervasiveness of n~eclical errors which account for thousands of patient cheaters every year as describer! in To Err is Hump (19991. In tire initiatives seconc] please tire report Crossing t1'e Quality C/?as~n: A New Health System for t/~e 21st Century (2001) was r eleased offering a comprel~ensive vision for flow tire i~ealtl~ system ant! larger pol- icy environment Origin be transformed to meet six key aims namely treat care is safe effective patient-centerec! timely efficient and equitable. Taxis report stimulated a national conversation about wheat needs to change on bile environmen- tal level at tire health care organizations ant! small practice levels as well as at the level where patients and clinicians interact. Taxis clialogue leas led to numerous public anti private sector efforts to reform the healths care system at each of tI~ese levels. These efforts include: national employers working to put safety practices into place in hospitals; health care providers acting to reclesign care clelivery acid experiment witty innovative financing; ancI fed- eral and local agencies including the Agency for HealtI~care Research and *echo IO[~1 QU31;1Y llIlitIatIVe d(.~ni.~d tale SerIouS and fa' reaching nature of the nations overall quality p'*0bl~o..
HIGHLlGH]~D Rri3(}~s Quality (Al{RQ) and tile Centers for Medicare/Medicaid Services (CMS), pl o- ducing quality report cards al d paying for quality demonstrations, among otiose activities. r --a---= ~ I~~~~~~~J Crossing the Quality Chasm also has provided a very important fi-ame- work for tile il,~plementatio'~ or third please of tile lOM's Quality l'~itiative. This phase includes three different types of efforts all focuses! old r eclucing e~lviro'~l~ental barriers: developing reposits Blat lay out a strategic direc- tio~ for a particular area within tire framework of tire Quality Chasm r eport; designing demonstration ideas or tools and tecl~iques, which aid in il~ple- me~ti~g that strategic direction; and fostering collaborations between tire IOM acid aiders wire are working to redesign tile health system. Tire following upcoming and released reports and convening activities reflect tire b~-eadtI~ and diversity of issues that must be facet! to improve the quality of health care in tire U.S.: · At tire request of else Secretary of the Department of Healths and Human Services (D~HS), tire IOM cleveloped boIc} icleas Flat could be enactec! at the state and com- munity level to respond to system ills and guicle future larger scale reform. Tire ensuing report, Fostering Rapid Advances in Hec`It/~ Core: Learning from System De~no'Jst'-atio'~s (2002), focused on ~ edesigning primary care ant! care for ti~ose with At tI3e re9~t of the Sexy of shed Department <~f Ittealit, and Hunlan Services' the t0M 40~oped bold ideas*.~o (respond tO System i! ISeas chronic conditions, creating an i~fo~matio~ and communications technology inn astructure, making health insult ance cover- age available and affordable at tire state level, and refor~ni~g ~nall~ractice to make it patient-centered, safety focused and nonjudicial. · In January 2003, tile IOM issued tire repo't Priority Areasfor National Action: Transforn?i/~g Healt/? Care Quality (2003), also at tire request of DHHS. Tire ~ eport r ecommencIs 20 priority areas that collectively span preventive, acute, chronic, and palliative care, and two interventions- care coordina- tion ant! self-management/health literacy- Pleat cross each of these domains. As a follow up to taxis report, the IOM is I~osti~g a summit in January 2004 that will involve both national ant! focal leaders in clevelop- ing work plans for redesigning care at the community level for seven of tire 20 priority areas. The areas of focus include asthma, congestive impart fail- ure, clial~etes, major depression, and pain management for tl~ose with advancer! cancel; as well as two crosscutting areas: care coordination and patient self-~anagen~ent. Tunis summit will provide con unity leaclers 7
v~~ 7~~ art I Amp jamb Off HE-AL71-] with tools ant! tecI~niq~es for overcoming barriers to in~proving care in Otiose five areas, as well as ideas anct support front Oliver con unities acid national leaders respectively. · I(ey Capabilities of an Electronic Health Record (2003) identifies a set of eaglet core functions that should be i'~corporatecl into electronic health Scores to guicle standarc! setting bodies ant! software clevelop~nent organ- izatio~s. otiose functio~alities can also serve as a too! for heat-care organizations as tizzy compare different IT systems, and consider which to adopt. These functionalities may guide tire federal ~,ove~nn~e'~t as tired consider ways to encourage I~ealth-care organizations to implement elec- tronic health recorcis. · Tire Quality Chasm report also reco~n~nencled that an i~tercliscipli- ~ary summit of leaders be I~eld to develop next steps for health professions education. Taxis summit was hosted by the IOM and held in June 2002 anc! involves! 150 leaciers from education oversight organizations practice environments purchasers consumer groups ant] professional associations among others. Tire summit participants ideas and tire resulting report Hea/tI~ Professions Eclucatio'7: A Bridge to Q~'ali~ (2003) icicle a mix of approaches wilds a central message that efforts to reform health professions education should be interdisciplinary. The approaches inclucle those related to over- sigI~t processes tire traipsing environment research public reporting and leaclersI~ip. Tire goad is an outcome based education system that better p~-e- pares clinicians to meet both the needs of patients acid tire requirements of a cI,angin~ health care system. · In Lendershi,v by Exa'~ap/e: Coordi'?ati'~g Goveran~ent Roles ill l~nproving Health Care Quality (2003J tire IOM recommends treat tire federal govern- ment use a multi-prong approach inclucling rewarcling I~igl~ quality providers wizen Riley purchase health care services leveraging their regula- tory power to establish clinical clata reporting requirements; using their own health care delivery systems e.g. tire VA (Department of Veterans Affairs) as laboratories to learn what floes and does not work for a 21st century healths systemic and finally applying health services research as they seek to develop the knowledge base and tools treat support quality enl~ancen~ent. ehoris tO tefOrn] health A ~ ~ ~ Paws eouL'at.~n sh(.~d be interdisCIplinary. $
Hiui-~-~9 Roars. FOoD ~~S UoDEx Tire Food C/?en?icnis Codex (FCCJ project is an activity of tire IOM's Foot! ant! Nutrition Boarc! that alas been supporter! by tire U.S. Food and Drug AcI~ninist~ ation (FDA) for 40 yeas s. Tire Codex is an impost tent component of national foot! safety defenses. It was establisi~ec! following the passage of tl~e Food Additives amentin~ents to tl~e fecleral Food, Drug, acid Cosmetic Act in 1958. To ciate, four eclitions of the Fooc/ CI?e'~?icals Codex (1966, 1972, 1981, and 1996) leave been published, as well as tire First (1997J, Second (2000j a'?c/ Thi'd (2001) Supplen~e'~t to the Fourt/? Eclitio''. Tire Fifth Edition is due for publication ifs late 2003. Tire FDA, by reference, incorporated into tire Coc/e of Fec/eral Regr`/ations many specifications pub- fished in tire fist tiered eclitio'~s of tile Food C/?emica/s Cociex. Canada, Australia, and New Zealanc! have also acioptec} the Codex as part of Elixir food regulatory systems. The FCC establishes standards for the purity of food chemicals to ensure consumer safety and promote uniform quality in production of such chemicals. The First Edition was limiter! to chemicals treat are acIdec] direct- ly to foods to achieve a clesirec] technological function. Succeeding eclitions upgraded tire specifications for these substances and addled specifications for processing aicIs, Silica come into contact witty foods cluring processing lout do not Sconce part of the, as well as tonne that are regardec! as foods lather titan as acicli- i'ECC-~ Is ~ terns ream fives. More recently, "functional" ing~eclie~,ts, finely used by many Janus which purportecIly perform a function in the facturers in food chen~cals Truman hotly but not on tire food itself, leave been addec] to Ellis list. Tire FCC leas continued to expand and evolve as able FDA approves new food additives ant! as advances ale Marie in scientific and manufacturing metI~ods and tecI~nolo- gy. Tile Fifth Editions will contain Bore titan 1000 monographs, many of totem new, ant! will feature a tI~orougl~ revision of FCC specifications. and ingredients Iabels. In able current era of globe' sourcing, which leas promoted tire entry of many suppliers of food chemicals and ingredients fiom other countries into tile United States market, tire FCC provides identity, strengths, and purity specifications for food chemicals that are recognized nationally and internationally. "FCC~grade" is a term routinely user! by many manufactur- ers in food chemicals and ingredients labels. Users of these substances, in turn, often require from suppliers fiat sucks substances be FCC compliant. In recognition of these standards, tire FCC has been incorporated into the cat
Art 'Lyle I~ {)7 ~ lPE~ CPl] I(~L I.~3~, food additive legislation of several countries amuck is user! worIc~wide among n~a~ufacturers acid users of food chemicals and ingredients. FCC specifications are continuously updated I~asec! on science acid in accordance wield the rapidly increasing pace set by FDA approvals. Without frequent updating of the FCC, American consumers could be exposed to many new food aciclitives for which thieve would be Rio agreed upon purity specifications. As concertos increase about tire protections of tire food sul~- ply fi-o~n inte~tio`~al contamination tire FCC also provides a scientific basis for scat ee~i~g food chemicals and ingredients. Tire primary goal restrains: to clefi~e tire quality of fooct-gracle cI~e~nicals in terms of icle'~tity7 strength acid purity based on tl~e elements of safety amuck good ~ . . manuractu~ng practices. 1~L THREATS TO ~ EALl ~ ~ Tire lOMs interest and involvement in addressing tire challenges of emerging microbial retreats to health leas spanned more titan a decade ant! yielder! severe ant! global security. important contributions to public lath In its 1992 report Emerging l'?fectio'~s: Microl~ia/ Threats to Hec:It17 in tile United States, the Institute of Meclicine pointed to major cl~allenges for else public I,ealtI~ research and medical care communities in detecting ant! managing infectious disease outbreaks and monitoring the prevalence of endemic Etnc3~-ing Infertions~ Microbial Threats [o Health iI7 the United Sfal:~. provide~'tI~e basis for the CDC:Ps Nat't,~! Center for nfe`~ti o u s D i S£~S ~ 994 dH ] ~ 998 strateg'~ plans to address the threat off twig infe`~:~s HOLtIORO.~* (:) diseases. The ~ epo't s ~-eco~nn~endations proviclec! tire basis for tire Centers for Disease Control anti Prevention s (CDC) National Center for- Infectious Diseases 1994 and 1998 strategic plans to acIdress tire thereat of emerging infections national- ly. The lOM report is credited also as tire catalyst for tire National Security Council s charge to tile Committee on International Science Engineering and Technology (CISET) of tI1e WIlite House National Science and TecIlnology Council to consider tire global threat of infectious diseases. To furtI~er illuminate tIlese issues, tile Centers for Disease Control and Prevention, along witty the National lustitutes of Healths, asked the lOM to convene the Forum on Emerging Infections (1996) now known as tire
HIctILlGI-~D REl)~Ryr^S Forum on Microbial Threats, to foster continuing and structures] opportu- nities for clialogue around areas of sheared concern among stalcel~olclers within the public ant! private sectors. In r ecent years, sucks cat oss-sector clia- togue leas precipitates! collaborative consideration ant! action around dis- eases on Nan heat, microbial and disease vector r esistance, biological treats and terrorism, tire impact of globalization on infectious disease emergence, ant! tl~e infectious causes of carbonic diseases. IOM's most recent report, Microbia/ Threats to HealtI7: En7e'~ge'?ce, Detections, acid Respo'?se (2003, examines the complexities and challenges posed by infectious diseases and tire colic esponding Fence treat contribute to else emergence and reemergence of Close tale eats. Tire report recognizes tire vulnerability of populations in all nations as a thereat not only to per- sonal healths, but also to public safety, economic stability and development, and 'rational and international security. Building on the factors of emergence icle~tified in the 1992 report, taxis report explores an expander! number of human-microbe interactions that contribute to disease. Moreover; tire r eport describes how the convergence of any number of factors (e.g., biological, ecological, and political) creates an environment in which infectious dis- eases can emerge acid Second rooted ilk society. Tire ever-worse~i~g HIV/AIDS pa'~ciemic, tire esurgence of once manageable diseases, such as *A coiiv6~0 of HEY ~ ~ n~ ber of [~' ~ (~*, biological ecologic Political) Creates all envy ron~nent in which ~nfec- tI(7US ~iSCdSCS CdI] CI~(gO anti Ib`~ome rooted ~n SoCiely. tuberculosis, tire emergence and spread of drug resistance and newly identifiecl pathogens sucks as tire SARS virus, and tire first use of biological terrorism in tire United States reflect tire formidable problems treat challenge incliviclual agencies, governments, acid markets. Tire report's recommendations propose a range of actions neecieci to keep pace with our microbial competitors and to define meaningful and sustainable solutions. Specific guiclance is provict- ecl to improve and entrance domestic and global public health capacity, infectious disease reporting and surveillance systems, workforce educa- tion, and the availability and development of effective countermeasures to clisease. Tire report's recommendations are currently uncler consideration by numerous fecleral and national ant! international decision -.
[~;1R,~.~\r(- 'art I4~ CRI]~AL iS~StIES Ifs IDEALS DIETARY ~~:~E INTAKES fOR [~1f,, ~~RBOHY-~~ Fond' Iffier' army A~o Aches ACtOs! Cno~..~ao~..' PRoTElN! AND More titan 60 years ago, tire Food acid Nutrition Boarc] issued its first set of Recommenclec! Dietary Allowances (RDAs) for vitamins minerals protein and energy in response to tire Wa' Depa'-t~nents concern during World War 11 over the nutritional fitness of new recruits malnutrition among existing to Cops and tire need to provicle adequate nutrients to mal- nourisI~ed populations after Riley were liberated by Allied troops. Since 1941 RDAs slave served as tire basis of almost all fecleral and state food and nutrition programs and policies ant! leave been revised nine times witty tire list of RDAs growing fiord eaglet to 27 nutrients in 1989. Since the publication of tire 10th and last edition of tire Recommended Dietary A/Iowances in the Unitec! States in 1989 and the Recon~menclec! Nutrient Intakes in Canada in 1990 new information leas e~ergect about nutrient requirements that warranted the development of upcIatec! guidelines. Over tire vast eight years tire IOM leas implemented an expanded system for determining the RDAs ant! Oliver nutrient baser! reference values now called Dietary Reference Intakes (DRIs). The new DRls are leased on scien- tifically grouncled relationships between nutrient intake and indicators of goof] I~ealtl~ as well as tire preventions of cl~ro'~ic diseases in annarentlv healthy populations. fir r ~ ~ In this recent report, Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, CI~olestero/, Protein, a''d An~i`?o Acids, tire sixths in a series providing Dietary Reference Intal~es (DRIB) clevelopec] jointly by Ames ican and Canadian sci- entists, tire DRI recomme~clations are expanded ~~. to meek the body's frailly ~ utritional needS Wil'Ie mlnIn117~.g rISk Ior chronlC d`~' adulls should con semen 45 to 65 percept t'[ their total calories from carbohydrates' 20 to 35 pat from fat, and ~ (3 to 3!; '~t fan proteins to include carbol~ycirates fiber; fat fatty acids cholesterol protein and amino acids collective- ly renown as the macronutrients as well as ener- gy amuck physical activity. Tire report recommends that to meet the bodys daily nutritional neecIs winkle ~ninimizing risk for chronic disease aclults should consume 45 to 65 percent of their total calories frown carbohydrates 20 to 35 percent from fat and 10 to 35 percent from protein. These are of considerable i nportance to federal agencies in Piglet of tire growing concerns related to Ft r,
11~}~ kr~r~.: consumption of specific dietary components such as bans fatty acids or cholesterol and increased risI; of chronic diseases, inclucli~g cardiovascular disease ant! cancer Tire acceptable ~ anges for cI~ilctren are similar to tl~ose for aclults, excels treat infants acid younger cI~ilcire~ need a somewhat i~igI~- er propo'-tion of fat in their cliets. These ranges may be more useful! and flexible fo' dietary planning titan single maximum values r econ~mencied in the past. Sponsors of tire report, including tire U.S. Departments of Agriculture a'~d of Healths ant! Hun~an Services, as well as Healths Canacla, a clivisio~ of tire Canadian government, also asked tire Academies to specifically provide guidance by defi~i~,g "dietary fiber" for tire pur- pose of regulating 'nutrition labels on foods, and on determining adverse Stealth consequences of consuming sugar added to foods such as cakes and beverages compared to other sugars such as those naturally found ire fruits ant! dairy proct- ucts. New products that meet regulatory definitions of fiber have recently been marketed, yet isolation procedures and definitions of tire tern vary greatly creating, tire neec] for a uniform concept. If aclopteci for use in foot! regulations, tire new set of definitions will cletermine which fi~er-like food acIclitives are counted as fiber on tire mandatory nutrition facts food labels. Sponsors of chew report .~.z~sked ti~e Acade~s io Specifically provide go jU" ance by defining '`dieli;try [ther''*~. Tire r eport~s recom~ne~clations pi ovicle tire basis for tire current review acid upcIate of Dietary Guicleli~es for Americans, to be completed by 2005 by an advisory committee to tire U.S. Departments of Agriculture and of Healths and Human Services, and similar evaluations in Canada. AcIclitionally, a follow-on study by tire Food and Nutrition Board is uncler way. Requested by Healths Canada, tire U.S. Food and Drug Adn~inistration, ant! tile U.S. Department of Agriculture, it is to provide specific guidance on flow to adapt tire DRls for use as reference values off foot} labels. Taxis will facilitate harmonizing food labels between tire two countries, a move strongly supported by tire foot! industry. In a related study, tire U.S. Department of Agriculture leas asI<ec! the Institute of Meclicine to recom- mend foocIs to include in tire food packages proviclec] to participants in tire agency's Supplemental Feeding Program for Women, infants and CI~ilciren (WIC), in line witty tire new DRI recommendations.
/~(F l~ Ft,']-~a CRI1'l(~AL iSSt'ES IN ilEAL7~ ROTECTING ~~H PARTIC] PANTS Tire explosion of knowledge emanating Mom basic science efforts, sucks as tire Human Genome Project, will lead to previously unimagined tI~era- pies ant! an eta of ir~clividualized meclici~e. The translation of discoveries in funcIamental and applier! science into useful clinical and public health inte~ve~tio~s clepends upon rigorous clinical trials involving large contorts of patients with appropriate phenotypes for studies. Such trials in turn, require a strong ant! effective system to pi otect tire individuals wire partic- ipate in totem. Mounting concerns about tire well-being of research partic- ipants acid tile capability of existing approaches to erasure participant protection, led tire Department of Healths and ~ ~.a Set of com plenlentary e`Ee~s anti activities are necessary to enSure adds 9~e prt')~.iOn for reSearci] partiCIpantSe Human Services to com~nissio~ a comprehensive assessment of tire national system for providing participant protections. A fast-track first report, Preserving P'`blic Trust: Accreditatio'~ acid Human Research Participant Protections Programs (2001), focused on tire potential value of accreditation. 1~ tight report and ill the seconc! please report, Responsible Research: A Systems Approach to Protecting Research Participants (2002i, the case was macie that a set of complementary elements and activities are necessary to ensure adequate protection for research participants. Pilot testing accrecI- itation was identifier! as ogle promising approach to improve the system. Tire reports also recommenc] that fecleral oversight be extencled to all r research regardless of tile sponsor; call for greater public participation in Else ethical oversight of research; and make recommendations about eclu- cation coordination monitoring ant! othe~-topics. Tire reports leave resulted ilk a number of actions by tile federal govern- ~nent. Tire Office for Human Research Protections (OHRP), tire Food ant] Drug AcI~ni~istration (FDA) tile National institutes of Heat ant! tire Department of Veterans Affairs coordinate tire clevelopment and dissemi- ~ation of ethnics education practices. In addition OHRP ant] FDA require that researcl, organizations are notified of deficiency warnings and r elated communications by regulatory agencies ant] are harmonizing safety moni- toring guidance inclucling standard pi actices to clefine ant! report adverse events. Tire Secretary s Advisory Committee for Human Research Protections will acicI'ess a number of tire committees recommendations ant! advise tire Secretary of DHHS flow to proceed. Legislators also have citec! tire ~ eports and intend to build on tire co~n~nittee s r ecom~nencIatio~s in legislation to extent! federal oversight to all research.
{flGu~J!~7~n 17~s A number of tire report's recomme'~cIations can be in~ple~ne~ted witi~- out direct government action. Their explicit incorporation into tire accrect- itation sta~darcIs of tire Association for tire Accreditation of Human Research Protection Programs and the Partnership for Human Research Protection is a notable early result. Tire committee's recomn~endatio`~s leave been widely cliscussec! in the research community ant! elsewhere, ant! metes oftl~e lOM's Clinical Research Rou'~dtable leave consiclerec! flow to imple~ne~t then. Other organizations also are evaluating tire reports ant! ~ietern~ining tl~ei'. next steps ilk Piglet of tire recon~mendations. pAL LlAT-~NfE AN D EN 0~ ~~ ~E tic ~ ~ [-HEIR tAMIt-~S ~,\~E FOR ~~> DREN Flats In 1997, tire Institute of Medicine publisI~ec] Approaching Death: n?provi'~g Care at the Earl of Life, tire first comprehensive, eviclence-basec! report on taxis subject. Improving Palliative Carefor Cancer follower! in 2001, builcling and extending on tile earlier report, witty a focus on tire quality of palliative ant! encl-of-life care for cancer patients. In a new report, When Chi/ciren Die: Imyrovi'~g Palliative anc! End-of-Life Care for Chilciren airy Their Families (2002), tire IOM examines care for cl~il- ctren with fatal or potentially fatal n~eclical concii- tions and tI~eir fannies. Although finest children leave some cI~a~acte~-istics and problems in co~n- mo~ witty very ill adults, tipsy also present special concerns and complexities. For example, where- as aclults most often die of Impart disease and otiose chronic conditions, tl~e leading causes of Neatly in cI~ildi~ooci are problems relater! to prematurity ant! cl~ildbirtI~, congenital anomalies, ant! intentional and unintentional injuries. A cl~ilct's Neatly may be tire most stressful and painful experience treat a family can face. A chilldl~s dearth Clay 1~` the ',7~t stressful anti painful! experience that ~ fancify can face. Unfortunately, children and families too often fad! to receive palliative, e~cl-of-life, and bereavement care that meets tI~eir special physical, psycI~o- logical, and spiritual needs. To improve care, tire report recommends changes in four broac! areas: · Organizing anti delivering cervices: Develop care guidelines and pro- tocols as a basis for assigning responsibility and evaluating and taken r Improving performance; 15
BIND OWE Firms CRI11~AL i.~lJES IN IDEALS . Finallcillg care: Eliminate hospice coverage requirements for a 6- montI~ prognosis and tire foregoing of curative ant! life-prolonging care; reduce restrictions on palliative care benefits, including consultations ant! parent counseling; · Educating health professionals: Provide t~ndergracluate, graduate, post- graduate, and continuing educations in palliative, end-of-life care, and bereavement care tailorec! to the responsibilities of every professional Gino cares for children; Alice · st`~engt/?el~ing the knowledge base: Set priorities for research in pallia- ti`re, end-of-life, Alice bereavement care. Since the report was released ilk miti-2002, a group of clinicians, eclu- cato'~s, researcl~ers, and policy ant! financing experts leave organized to promote tire implementation of the report's rec- ommenciations. Legislation baser] on several of the committee's proposals has been introducer! in Congress, and the National Institutes of Healths leas publisher! priority areas for research in pedi- atric palliative and encI-of-life care tegisIati(~n based on Sever al of the comm'tiee's pros P058~5 Ilas been ;~d ~ I] ~~.~S.. ~ IMM(~N SAfETY Tire Immunization Safety Review Committee was established at tire request of tile Centers for Disease Control ant! Prevention and tile National institutes of Health to provicle inclepenclent timely ant! objective assis- tance to tile Department of Health and Human Se-vices in evaluating the available evidence on a series of in~unization safety concertos. For each hypothesis to be examined the IOM committee assesses Motif tile scientif- ic eviclence acid tile significance of tile issue foil society. Tile scientific assessment leas two components: an examination of tire epide~niological ancI clinical evidence regarding a possible causal relationship between the immunization and the acIverse event; anti an examination of experimental evidence for ally biological mechanisms relevant to tile hypothesis. Tile significance assessment addresses such considerations as the burden of tile health risI<s associated witty tile vaccine-preventable disease and witty the adverse event in question, as well as tile level of public concern about tire safety issue. Over a three year period, the Immunization Safety Review Committee leas issuer! seven reports assessing putative adverse effects ant! immuniza-
Hi0~) p~33~5 tions. Titus fat; tire committee has consiclerec! tire issues of multiple immu- nizations and immune dysfunction, hepatitis B acid demyeli~ati'~g disor- clers, SV40 contamination of Polio vaccine and cancel; vaccinations and sudden unexpected cleated in infancy, ti~i~erosal-containing vaccines ancI- neuroclevelopn~ental clisorclers, and measles-mumps-rubelIa vaccine and autism. Tire project s})o'~sors, CDC and the NIH, have responded quicI<ly to many of tire policy-analysis and research recommendations. Foil example, the NIH leas pursuer! basic research on tire pl~ar~acokinetics of tl~i~erosal exposure, and else CDC is developing a case-co'~t'-o} study to study tire putative relationship between vaccines and autism. CDC a',] otI~er federal agencies prominently link From tl~ei'- websites to the committee reports. Decisions by Special Masters of the Vaccine Injury Compensation Program frequently cite IOM reports as evidence supporting or refuting a vaccine-causation allegation. At a recent cor~fer- ence ot Immunization program managers, sever- al state ant! clinic-baseci providers reported tight Riley use executive summaries and abstracts as communication tools for parents Silo desire .~th~ woolly of the> commilt~ tee is [~equentII Cltet! as an a- voice to the ge>~! pubic in mass media stories about So Safe`ty.~. more information about a specific vaccine safety concern. Committee reports ant! tire material on tire IOM Immunization Safety webl~age, which includes aucliofiles and PowerPoint presentations front public workshops of tire co'n~nittee, al e used as teaching tools. Finally, tire won t; of tire com- mittee is Frequently cited as an authoritative voice to tire gene'-al public in mass IT~eciia stories about vaccine safety, including in Paracle magazine, tire BBC, tile Dianne Echo Show on National Public Radio, and America Baby. iMAtLPOX \~ATION PROGRAM IMPLEMENTATIt)N 1~ 2002, else Centers for Disease Control and Prevention requested tar- getecI advice from the IOM on tire implementation of a ",ore-event" or pre- cautionary s~nalIpox vaccination program. CDC charged tire IOM witty pro- vicling guidance on flow to best implement tile President's policy regarding pre-event smallpox vaccination acicIressing tire following Piglet areas: tile informer! consent process, contraindications screening, the system in place to assess tire safety profile of tire smallpox vaccine, gwiclance for tile treat- ment of vaccine complications, professional training programs CDC is developing, tire communications efforts, and guidance CI)C offers to states in developing their implementation plans, and overall progress at acI~iev-
IN~PA/~\r(~ 1~- F(1rI-~ CRIlY(~A! I.~S IN HI~`AL71-] ing the goals of the program. In tl~e process of providing rapid and timely advice to CDC, tire IOM Committee on Smallpox Vaccination Program lmple~nentation leas held several meetings ant! issued four letter reports treat leave contributed significantly to improving CDC's implementation of tire program. Based on tire committee's recom~nendatio'~s, CDC has put into opera- tion act active su~-veilla~ce system to supplement else data collected by tile Pre-event Vaccinations System and to Whelp ensure Fiat all adverse events fol- lowi~g s~nalIpox vaccination are reported and investigated. 1~ tI~eir efforts to encourage Congress to pass a smallpox vaccine compensation program, professional groups representing some of the first smallpox vaccine recip- ients citec! tire committee's recognition Fiat informed consent of tire vac- cinated individuals could be affected by tI~eir understanding of the com- pensation available (or lacks thereof for serious adverse reactions or subse- quent medical costs. The committee's recom- menciations about critical education and com- munications issues prompted CDC to develop ant! implement informational streets for I~ouse- hold contacts of vaccine recipients and to prospective vaccine recipients witty information about the status of compensation issues. AcIditionally, CDC leas built ill a great deal of flexibility foil states to define priorities for pre- pa~edlless, i~ClUClillg pausing to evaluate and consider next steps. Taxis is congruent with the com~nittee's recommendations about balancing nation- al goals with local needs and circumstances. BaSe(] on the Comnlitiee/S re~mnnendatit.~, cOc haS put into operation an active Surveillance Syste tt, sup~3~t t~ 48~.~. ~~ I$~d by the Pre-~`ent va<;~n system.*. Tile National Vaccine Advisory Committee (NVAC) and tire Advisory Co~n~nittee Ott immunization Practices (ACIP) Inane quote of IOM reports ant! recommendations at their meetings in February 2003 (NNIAC) ant! June 2003 (AClP). IOM's call for a pause to evaluate the program anti ensure its continuing safety was part of tire (liscussion at NVAC and ACIP meetings, and ultimately, helped witty the development of those committees' recom- menciations for a delay in the vaccination program to ensure caution and allow for adequate evaluation. Additionally, tire April 2003 General Accounting Office report assessing tire progress of tire smallpox vaccina- tion program compared recommendations macle in tire IOM reports witty CDC's implementation of the program, and identified areas of tire program that needed improvement.
How- Rears Tur Fir or P~c Ht4~n .. .. . In 1988, tl~e IOM publisl~ec! The Fume of Public Health. Tire report defined public health as wheat society floes collectively to assure tire concli- tions for people to be Meaty acid presented strong evidence to indicate treat tire public stealth system tire organizational mechanism for achiev- i'~g tire best population I~ealtl~ was ilk Sisal ray. Although tire r eport described tire public stealth system as the govern~ne~tal public healtI, agencies and "tire associated efforts of private acid voluntary organizations ant! inctividuals," it focused specifically on ways to stre~g,-tI~en governmen- tal public health i',fiast~ucture. In 2001, a new IOM committee was con- vened witty else clears to create a fi amewo~-k for assuring populations healths its tire United States that would be mole inclusive than that of the 1988 report and tight could be effectively com- municated to and actec! upon by diverse commu- nities. In tire new report, The Future of t/~e Pub/ic's Health in the 21st Ce'~h''Ay, tile committee exam- ines Motif tire governmental component of tire public I~ealtl~ system and tire potential contribu- tions of Oliver sectors and entities. Tire report reviews tire nation's public Stealth capabilities and presents a comprehensive framework for how the government public health agencies, worI<ing witty multiple partners fiom tile public and private sectors as an intersected public Stealth system, can better assure tire Stealth of communities by: adopting a populations health approach that considers the multiple determinants of health; strengtI~en- ing tire governmental public I~ealtl~ infrastructure, tire backbone of tire public I~ealtl~ system; building a new generation of i~te~secto~al partner- sI,ips; requiring accountability from a'~c! among all sectors of tire public healths system; making evidence tire foundation of decision-~nal~ing; and enhancing and facilitating communication within tire public Stealth system. ma new IOM con~nittee was convener wilds the charge to testate ~ fear [o ~ Kit [o ~ ins ~ ~ ~ i ~ g po p ~ ~ i] tion healLb in the taunted States that would her more incIusi`{e than that Or the ~ t388 report a'~d that c[-~d b~ ~f~f~ti~tr l y ~0 ~ ~ ~ ~ ~ t ed to ant! aCted opts by d IverSe If- ~~ ~ n ities. Tire report was launcI1ed at tI1e 130th Annual Meeting of the American Public Healths Association (APHA) ilk November 2002. Aucliet~ce r eviction was brisk, including enthusiasm for the content, commitment to clevelop action age`~clas ancl, From tire founclations, interest ill a program of grants to implement several of tire more far-reaching recommendations. Dissemination activities since lau'~cl~ Slave incluclec! presentations at meet- ~3
[~N,lIN(t 1~E ~(Jr] l/~3~ CRI116~AL i55~lrs I,\ arm- ings of over twenty major national and state public health and professional leadership organizations Congressional briefings and meet- ings witty members of the press. At tire fecleral level CDC bias acloptecI tire report as tire frameworks or starting point for its strategic planning process. Several programs within CDC slave used the report to launch activities to strengthen tire public health worlcforce acid to improve public healths system performance. Else report was also featured at tire joint meetings of National Associations of County and City Healths Officials anti Association of State and Tea ritorial Health Officers ifs September 2003. In acIdition tire major public heat organizations leave cleveloped committees to i~npleme~,t tile report recommendations. A related report Who Will Keep the Public Healthy? Eclucating Public Health Professionals for the 21st Century, was released on November 4 2002 and leas since become tire focus of mucks planning ant! activity related to developing tire public Baltic workforce. Tire Public Health Workforce Development Collaborative leas made tire r eport tire focus of strategic plan- ning effortsaclopting tire core recommender! competencies generating a set of curricula anc! cleveloping a research agencia. Tire Council on Linkages between Academia and Public Healths Practice continues to devel- op tire strategy to assure that tl~e nation co'~sid- ers certification of public Stealth professionals. Tire Association of ScI~ools of Public Health leas macie several issues and recommendations in the report a priority for discussion and actions at its upcomin meetings. The American Public Healths Association is developing a convener project which will include an annual forum at tire annual APHA meeting to report Ott tire progress made to implement recommendations. Act e~tI~usiastic reception by the American College of Preventive Medicine led to adoption of a strongly worded resolution by tire American Meclical Association to advance tire role of the physician in public health and re-constitute tire medicine-public health initiative. The Public Healll' Work force DOYOlOPR7~[ Art ~ ~ ~ ~ l-A ~ ~ ~ ~ the teport the focus of Lits] straten~c nIan hi nu efforts
HIGI11-~-~) PEl)~S Georgia State University r ecently developer! a new untlergracluate MPH program based on tire proposed framework and recon~mendations of tire Who Will leveed the Public Healthy? report. If approved, as expected, by the Board of Regents, Georgia will be tire first state to adopt ilk full tl~e recommender! Framework.
Selected Recommendations for Global Health ant] Infectious Disease Microbial Threats to Health: The United States should seek to enhance the global capacity for response to infectious disease threats, focusing in particular on threats in the developing world U.S. federal, state, and local governments should direct the appropriate resources to rebuild and sustain the public health capacity necessary to respond to microbial threats to health, both naturally occurring and intentional. C DC, DoD, and NIH should develop new and expand upon current intramural and extramural programs that train health professionals in applied epidemiology and fielcl-based research and training in the United States and abroad. The U.S. Secretary of Defense, the U.S. Secretary of Health and Human Services, and the U.S. Secretary of Homeland Security should work closely with industry and academia to ensure the rapid development and deployment of vaccines for natura~- ~y occurring or intentionally introduced microbial threats to national security. Further, CDC, FDA, professional health organizations, academia, health care cleliv- ery systems, ancl industry shock expand efforts to decrease the inappropriate Else of anti~nicrobials in human medicine. (Microbial Threats to Health: Emergence, Detection, anc! Response, 2 003 ~ Global Emerging Infections Surveillance: Support for the Global Emerging Infections Surveillance and Response System of the Department of Defense and the facilities that sustain it should be increased to allow GEIS to completely fulfill its potential Pursuit of collaborative, we~-coordinated relationships with international organizations, U.S. Government agencies tincturing other DoD laboratory entities), and relevant agencies of foreign governments shots be continued and expanded to the extent possible. (Perspectives on the Department of Defense Global Emerging Infections Surveillance and Response System: A Program Review, 2001 ~ Brain Disorders in Developing Countries: Extend and strengthen existing systems of primary care to deliver health services for brain clisorclers. Secondary and tertiary centers should train and oversee primary care staff. orovicle referral canacitv and ~ ,, orovicle ongoing supervision and support for primary care systems in developing countries. Make cost-effective interventions for brain clisorders available to patients who will benefit. (Neurological, Psychiatric, and Developmental Disorders: Ivleeting the Challenge in the Developing World, 2001 ) ~
