How To Prepare For A Mallpox Outbreak

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1 Iue Brief No. 1 Bioterrorim and Health Sytem Preparedne Addreing the Smallpox Threat: Iue, Strategie, and Tool The Agency for Healthcare Reearch and Quality (AHRQ) i the lead agency charged with upporting reearch deigned to improve the quality of health care, reduce it cot, addre patient afety and medical error, and broaden acce to eential ervice. AHRQ ponor and conduct reearch that provide evidence-baed information on health care outcome; quality; and cot, ue, and acce. The information help health care deciionmaker patient and clinician, health ytem leader, and policymaker make more informed deciion and improve the quality of health care ervice. U.S. Department of Health and Human Service Public Health Service Introduction A bioterrorit attack uing mallpox would poe a ignificant threat to public health in the United State. The reintroduction of the mallpox viru which ha not infected anyone in the world for nearly three decade into an unprotected population could caue ubtantial morbidity and mortality and overwhelm public health reource. While the threat of uch an attack i of national concern, it i at the local level that public health official and health ytem planner mut be ready to repond. On March 3, 2003, an audioconference ponored by the Agency for Healthcare Reearch and Quality (AHRQ) examined the implementation of the Center for Dieae Control and Prevention (CDC ) mallpox vaccination program and trategie to ait public health official in reponding to a potential mallpox outbreak. Panelit included: William Raub, Ph.D., Deputy Aitant Secretary, Office of Public Health Emergency Preparedne, U.S. Department of Health and Human Service; Nancy Ridley, Aitant Commiioner, Maachuett Department of Public Health; Edward Gabriel, Deputy Commiioner for Preparedne, New York City Office of Emergency Management; Nathaniel Hupert, M.D., Weill Medical College of Cornell Univerity; and Thoma Terndrup, M.D., Director, Center for Diater Preparedne, Univerity of Alabama at Birmingham. Following preentation by the panelit, litener were invited to ubmit quetion during a quetion and anwer period. Thi iue brief review vaccination effort and identifie tool to help hopital adminitrator and emergency reponder prepare for an outbreak of mallpox and other deadly dieae that can be caued by biological or chemical attack. The Smallpox Threat The lat cae of mallpox in the United State occurred in The lat natural cae documented in the world occurred in Somalia in In thi country, vaccination againt mallpox topped in

2 1972 and, in 1980, the World Health Organization declared that the dieae had been globally eradicated. Although there i no reaon to believe that mallpox preent an imminent threat today, the terrorit attack of September 11, 2001, and the anthrax attack that followed them have heightened concern that terrorit may have obtained the viru and will attempt to ue it againt the American public. Smallpox i one of ix biological agent that the CDC view a a highpriority threat becaue of the effect of the dieae and it potential for largecale diperal. 1 William Raub lited five reaon why mallpox i conidered a threat: It i highly lethal; without vaccination, 30 percent of thoe infected can expect to die, and of thoe who urvive there can be lifelong, eriou morbiditie of variou type; The dieae i readily communicable from peron to peron; repiratory droplet are ufficient to carry the viru, and therefore ordinary day-to-day contact can be ufficient expoure to pread the dieae; Few people have effective immunity; with vaccination having ended in the United State in the 1970, individual born ince that time have no immunity and thoe of u who were vaccinated earlier have little or none, depending on the length of time involved; We have no etablihed treatment; the vaccine itelf i protective within a few day of expoure, but 1 The other agent are anthrax, botulim, plague, tularemia, and viral hemorrhagic fever. once the ymptom preent we have no drug or other mean to treat, much le cure, thi dieae; and Enemie of the United State may obtain the variola viru, which caue mallpox. After eradication of the dieae in 1980, only two official tockpile of variola viru remain one in the United State and the other in the Soviet Union. Much of the former Soviet Union upply i till not accounted for today. When cientit and engineer left that country following the breakup of the former Soviet Union, we fear that they left with more than their know-how, aid Dr. Raub. They may indeed have left with ample of the viru. Smallpox Preparedne Effort Preident Buh announced the Smallpox Vaccination Program in December In the firt phae, the U.S. Department of Health and Human Service wa to work with tate and local government to form volunteer Smallpox Repone Team, compoed of health care worker and emergency repone peronnel, who would receive a pre-event inoculation. The repone team would thu be protected againt mallpox and would be ready to mobilize immediately in a mallpox emergency to vaccinate other. The firt phae alo included vaccination of military peronnel who were or might be deployed in a highthreat area, and voluntary vaccination of State Department peronnel aigned to uch area. William Raub treed that the program i voluntary. He went on to explain that the plan included two other phae. Phae 2 would include the voluntary vaccination of additional member of the health care and public afety communitie who, in the event of an outbreak of mallpox, would be among the very firt to be expoed to cae and who would want to be protected to be able to carry out their baic reponibilitie. In the third phae, voluntary vaccination would be available to member of the general public who, in the Preident word, init on being vaccinated now. Firt, I would tre that the program i entirely voluntary. Smallpox doe not exit in the world right now; we believe it would be inappropriate to have any mandatory vaccination campaign for a dieae that doe not exit. But becaue of the bioterrorit threat, ome preparation eem important. William Raub, Deputy Aitant Secretary for Public Health Emergency Preparedne After the Preident announcement, CDC promulgated guidance for the Smallpox Vaccination Program, made educational material about mallpox and vaccination available to hopital, clinician, and the public, and provided mallpox vaccine to the State. The program wa implemented in late 2

3 January Vaccination Program Challenge In the 5 week between the implementation of the program and the audioconference, not urpriingly, ome iue aroe. Dr. Raub identified two. The firt wa the logitic and cot anticipated for Phae 2 of the vaccination program. He explained that mot State were able to handle the logitic and were finding fund for Phae 1 (for which CDC had targeted a total of 500,000 vaccinee). With up to 10 million additional health care worker and emergency repone peronnel projected to be vaccinated in Phae 2, however, ome State and local health official were apprehenive about the financial reource that would be needed to implement uch a large-cale effort. On that cale, the ditribution of vaccine, the type of clinic or other arrangement for vaccination, and acce to thoe ite would alo poe a major logitical challenge. The econd iue wa the abence of guaranteed compenation for vaccinerelated injurie. In many State, but not all, workman compenation cover the compenation needed for illne reulting from the poibe ide effect of vaccination. Similarly, many health inurance program, but not all, provide coverage for the health care cot aociated with advere event, but none of them cover the cot aociated with lot work. A a reult, State official and hopital and other were proceeding cautiouly with the vaccination program in the hope that a olution to the compenation problem would be found. The Maachuett Experience Maachuett offer an example of one State effort to implement the Smallpox Vaccination Program. A Nancy Ridley explained, the Maachuett plan i built around it acute care ytem and it emergency repone planning region. Maachuett doe not operate on a county health ytem, but ha 76 acute care hopital with emergency room that make up the core of the acute care ytem. The State ha recently been divided into even emergency repone planning region o that each region ha an approximately equal population and number of hopital. The Maachuett approach to Phae 1 tarted with planning by a tatewide mallpox workgroup that included 40 or 50 active member repreenting many different contituent group. Their Phae 1 plan had two component. Firt, State health department peronnel would be vaccinated and would, in turn, vaccinate approximately 7,600 hopital taff, averaging about 100 per acutecare hopital. Second wa the vaccination of community repone team peronnel. Each of the 7 emergency repone region would have multiple 16-member repone team, which would require vaccinating approximately 150 community repone team member per region. Completion of the two component of Phae 1 wa expected to take up to 6 month. The Maachuett plan included everal precaution. Volunteer had to have been vaccinated previouly. There would alo be very careful creening of the volunteer and their houehold contact for contraindication. In addition, extenive followup would be required for advere reaction. In light of thoe precaution, the State wa not propoing or recommending furlough. In term of getting conumer and the public involved in the program, you need to have the continuou involvement of health care provider right from the beginning. Nancy Ridley, Aitant Commiioner, Maachuett Department of Public Health With regard to Phae 2 of the Vaccination Program, M. Ridley added another dimenion to the iue identified by William Raub. She decribed proceeding to Phae 2 a one of the mot controverial quetion we have had to face, and treed that moving to Phae 2 wa dependent on the leon learned during Phae 1. Specifically, he aid that what wa neceary to proceed to Phae 2 wa continuation of evidence to date that the program had been very ucceful, with very mall number of even minor advere reaction. The experience in Maachuett with the compenation iue wa that, 3

4 becaue worker compenation in the State doe not take effect until the fifth day, many larger employer had tated that they would covering thoe firt day. Similarly, health inurer had aid they would cover ide effect for both vaccinee and any contact. Smallpox Threat Require Coordination, Communication Edward Gabriel, Deputy Commiioner for Preparedne in the New York City Office of Emergency Management, treed that planning for a mallpox threat or any public health emergency mut begin with communication and coordination among local emergency authoritie. He decribed incident management planning a a way to bring everybody to the table and get them to peak the ame language. Everybody include not only hopital and emergency medical ervice, but alo local public health department and fire, police, and ambulance peronnel. In addition to peaking the ame language, incident management planner hould get to know one another on a firt-name bai, face to face, and hould conider each other a part of the ame emergency repone team. Local planner hould alo work with State and Federal repreentative. In repone to a call-in quetion, Mr. Gabriel aid that one of the leon of 9/11 wa the importance of coordination of emergency management at the local, State, and Federal level. It i important to know who the contact point are and where to go for what reource, how to get them, and how your chain work from the lower level to the State level to the Federal level. An epecially important element of that local-state-federal coordination in the event of any public emergency i communication with the public. Our experience from September 11 taught u the importance of projecting one voice and a conitent meage to the public, aid Gabriel. Nancy Ridley added that one of the highet prioritie in making a mallpox plan ucceful i being prepared to counter an epidemic of fear among the public. Do your preparedne planning not jut for bioterrorim incident but for all incident. Edward J. Gabriel, New York Office of Emergency Management New Tool Help Prepare for Deadly Dieae If a mallpox outbreak were to occur, a large-cale vaccination program would be neceary. Reearcher at Weill Medical College of Cornell Univerity have deigned a new computer model to help hopital and health ytem plan antibiotic dipening and vaccination campaign to repond to bioterrorim or largecale natural dieae outbreak. The model wa funded by AHRQ and developed by reearcher after teting a variety of patient triage and drugdipening plan. Now, for the firt time, hopital planner can etimate the number and type of taff needed to vaccinate an entire community in an efficient and timely fahion. For example, the model can quantify the taff required to vaccinate one million people over 14 day. The model can be downloaded to run on common preadheet oftware cutomized for ue by health official at all level of government, hopital adminitration, and emergency medical planning. Model like thi allow planner to think with number when deigning ma prophylactic repone trategie, aid lead model deigner Nathaniel Hupert of Weill Medical College. Modeling alo force a critical examination of aumption about how a large-cale vaccination plan would be executed, particularly the iue of reource availability. Dr. Hupert cautioned that while model are ueful to guide planning, they don t replace the real thing, which i exercie and drill that tet the repone of a health care ytem. Educating Provider About Bioterrorit Agent Dr.Thoma Terndrup, Director of the Center for Diater Preparedne at the Univerity of Alabama at Birmingham, demontrated the Web ite ( that he and hi colleague have developed to provide reource information and continuing education about rare infection and potential bioterrorit agent, including anthrax and mallpox, to health care provider. The bigget challenge, he aid, wa that there i limited or no clinical experience with many of thee agent, 4

5 and o the health care community need to truggle with recognition and awarene. Funded by AHRQ, the interactive creenaver on the Web ite include aitance with complicated differential diagnoi, continuing education module, related Web link, and publication option for the uer. The Web ite wa initially poted in October 2001 and ha been updated regularly, epecially for mallpox and anthrax. A pediatric model wa added in December 2002, and other module were being planned, including internal medicine and family practice to incorporate primary care phyician into the fold. Alo in the planning tage wa a dermatology referral module that would help medical provider to know when to refer a patient to the dermatology community. Update Four week after the audioconference, on March 26, 2003, CDC iued an adviory that people with known cardiac dieae hould not be vaccinated. CDC March 28, 2003, Morbidity and Mortality Weekly Report contained the new that even cae of cardiac advere event had been reported among the 25,645 civilian who had been vaccinated a of March 21, 2003, and that 10 cae of myopericarditi had been reported among approximately 225,000 primary vaccinee in the military mallpox vaccination program. In the military program, no cae of myocarditi or pericarditi had been reported among approximately 100,000 peron who had been revaccinated. CDC cautioned that a caual relation between mallpox vaccination and eriou cardiac event could not be excluded, and recommended that peron with known cardiac dieae be excluded from vaccination. Other notable event ince the March 3, 2003 audioconference include the following: March 31 CDC added a upplement on Smallpox Vaccine and Heart Problem to it Smallpox Pre- Vaccination Information Packet. April 30 Preident Buh igned into law the Smallpox Emergency Peronnel Protection Act of 2003 (SEPPA) (P.L ). The law etablihed a no-fault program to provide benefit or compenation to health care worker and emergency reponder who are injured a the reult of the adminitration of mallpox countermeaure, including the mallpox vaccine. May 5 HHS Secretary Thompon announced the releae of $100 million to the State to help them prepare for a poible mallpox attack and to trengthen the public health infratructure. The $100 million wa in addition to the $1.4 billion available to the State in Fical Year May 23 The Intitute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation iued it Letter Report #3 to CDC, reaffirming the recommendation from it firt Letter Report (January 16, 2003) that there hould be a paue in the program between Phae 1 and Phae 2. The IOM May report cited three reaon for the paue: to enure that expanded vaccination i a afe a poible for vaccinee and their contact; to modify plan, data ytem, and educational material to prepare for a new population of potential vaccinee; and to re-evaluate the vaccination program integration into overall mallpox preparedne nationally and locally. June 18 The Adviory Committee on Immunization Practice (ACIP) iued a Statement on Smallpox Preparedne and Vaccination in which it reiterate that it i critical that mallpox preparedne planning continue at all level of government. The tatement provide a lit of preparedne effort and activitie, including mallpox vaccination. It alo advie CDC not to expand beyond ACIP current, preevent mallpox vaccination recommendation, pecifically becaue the extent and everity of myopericarditi are not yet known. November 6 In it weekly update of Smallpox Vaccination Program Statu by State, CDC reported that a of October 31, 2003, a total of 38,759 civilian nationwide had received the mallpox vaccination. For More Information The complete audioconference on Addreing the Smallpox Threat: Iue, Strategie and Tool i available a a treaming preentation and a a text trancript on the AHRQ Web ite ( Information on the tool dicued in thi iue brief, and other tool and publication related to health ytem preparedne for bioterrorim, will be poted on the AHRQ Web ite a it become available. Pleae check the Web ite frequently. 5

6 AHRQ Pub. No. 04-P006 January 2004

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