International Health Regulations for U.S. Public Health Practitioners Updates for CSTE of the Implementation of the IHR January 2013
2012 CSTE Survey In early 2012, states surveyed on experience with International Health Regulations (IHRs) Responses received from all 50 states & DC Focus was on surveillance and notification requirements for potential PHEIC events Public Health Emergency of International Concern Information presented at International Conference on Emerging Infectious Diseases
Survey Results Familiarity with Surveillance Requirements Very familiar 11 (22%) Moderately familiar 22 (43%) Somewhat familiar 15 (29%) Not familiar 3 (6%)
Use of Annex II (Decision Instrument for potential PHEIC Notification) since 2007 Used 13 (25%) Not used 31 (61%) Unsure 7 (14%)
Interpretation Most states have little to no experience with IHRs Some not or minimally familiar with IHRs Turnover of staff since previous training Most have not had used notification algorithm Uncertainty about what happens with a notification Need for information sharing around the IHRs Division of Global Migration and Quarantine
What are the IHR? The IHR are an international legal instrument that is binding on 194 countries across the globe, including all the Member States of WHO. Their aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.
Purpose of IHR Global consultation on health measures Globally harmonized response Rapid information exchange
Structure of the IHR 66 articles describing Definitions, purpose, scope, principles, responsible authorities Information and public health response Recommendations Points of entry obligations Public health measures Health documents Charges General provisions IHR roster of experts, emergency committee, review committee Final provisions (e.g., amendments)
Structure of the IHR 8 Annexes I. Core capacities for surveillance, response and II. designated points of entry Decision instrument for assessment and notification of events that may be a PHEIC III. Model Ship Sanitation Certificates IV. Technical requirements for conveyances V. Specific measures for vector-borne diseases VI. Vaccination, prophylaxis, related certificates VII. Vaccination or prophylaxis requirements for specific diseases VIII.Model maritime declaration of health
IHR (2005) Entered Into Force in U.S. on July 18, 2007 Reservation The U.S. will implement the IHR under the principles of federalism Understandings Under the IHR, incidents that involve the natural, accidental or deliberate release of chemical, biological, or radiological materials must be reported Countries that accept the IHR are obligated to report, to the extent possible, potential public health emergencies that occur outside their borders The IHR do not create any separate private right to legal action against the Federal government
Public Health Emergency of International Concern (PHEIC) Definition Extraordinary event WHO Director-General makes determination of PHEIC
PHEIC Assessment Algorithm * Baker MG, Fidler DP. Global public health surveillance under the new International Health Regulations. EID; July 2006, Vol. 12. http://www.cdc.gov/ncidod/eid/vol12no07/05-1497.htm
Timing of Assessment & Reporting of Events At the National Level assess 48 hours notify 24 hours
U.S. IHR Assessment & Notification Process for Public Health Events U.S. States International Surveillance U.S. States U.S. Government U.S. Government Information input WHO Other NFPs National IHR Focal Point Department of Health and Human Services Notification of potential PHEICS* WHO Border Partner NFPs Canada and Mexico Assessment Agriculture USDA U.S. States Defense DOD Food Safety HHS; USDA Public Health HHS Homeland Security DHS ASPR: Resilient People. Healthy Communities. A Nation Prepared. * The HHS ASPR Serves as the Message Authorizing Official on behalf of the Secretary of the DHHS and the United States Government and has the ultimate responsibility to clear any notification of a potential PHEIC to WHO. 14
Who Makes the Decision at CDC to Report a Potential PHEIC? CDC Preliminary Assessment: Associate Director for Science at the National Center that owns the disease/event CDC Final Assessment: CDC PHEIC Analysis Team Center and Office ADSs CSTE representative State Epidemiologist (if event is only in one State)
What happens with a positive PHEIC assessment? < 24 hours of assessment CDC sends notification to ASPR ASPR/SOC sends not if icat ion t o PAHO & WHO, and to Canada & Mexico CDC or State Epidemiologist share information on IHR notification via Epi-X WHO assesses notification and decides whether to post on IHR secure Event Information Site (EIS) EIS accessible by all IHR National Focal Points PAHO or WHO may request additional information PAHO or WHO may assist in international or domestic aspects of disease control
U.S. Notifications of Potential PHEICs 2007 August: 1 Clostridium botulinum-contaminated chili; 2 Measles at an International Little League game September: 3 MDR-TB on an international flight December: 4 MDR-TB on an international flight 2008 March: 5 MDR-TB on an international flight; 6 Contaminated heparin products July: 7 Salmonella Saintpaul outbreak 2009 January: 8 Salmonella Tymphimurium outbreak March: 9 Influenza A H1N1 (swine flu Iowa); 10 MDR-TB on an international flight April: 11 Influenza A H1N1 (swine flu California); 12 Influenza A H1N1 (swine flu California) May: 13 Influenza A H1N1 triple reassortant (swine flu Minnesota) June: 14 E. coli O157 outbreak (cookie dough); 15 E. coli O157 outbreak (beef) August: 16 Influenza A H3N2 triple reassortant (swine flu Kansas) November: 17 Cluster of oseltamivir-resistant 2009 influenza A H1N1 virus infections (North Carolina) 2010 January: 18 Imported Lassa infection in traveler; 19 Swine influenza A (H3N2 Iowa) May: 20 Deepwater Horizon Oil Spill; 21 Swine influenza A (H3N2 - Minnesota) August: 22 Typhoid Fever outbreak due to imported frozen mamey pulp November: 23 Influenza A H3N2 triple reassortant (swine flu) Pennsylvania; 24 Wisconsin December:25 Influenza A H3N2 triple reassortant (swine flu) - Minnesota PHEIC declared 25 April, 2009 Respiratory 2011January: 26 Influenza A H3N2 triple reassortant (swine flu) - Pennsylvania June: 27 Guillain-Barre Syndrome (GBS) Arizona US and Sonora/Baja Mexico July: 28 Multistate (23) Outbreak of Human Salmonella Agona Infections Linked to Whole, Fresh Imported Papayas from Mexico August: 29 Influenza A H3N2 triple reassortant (swine flu) Indiana; 30 Pennsylvania September: 31 Influenza A H3N2 triple reassortant (swine flu) Pennsylvania; 32 Pennsylvania October: 33 Influenza A H3N2 triple reassortant (swine flu) Maine; 34 Salmonella Enteriditis linked to pine nuts imported from Turkey Multi-State Outbreak November: 35 Influenza A H3N2 triple reassortant (swine flu) Maine (1case); 36 Indiana (1case); 37 Iowa (3cases) December: 38 Influenza A H3N2 triple reassortant (swine flu) - West Virginia; 39 Influenza A H1N2 triple reassortant (swine flu) - Minnesota; 40 Novel influenza H1N1 Wisconsin: 41 H3N2 West Virginia 2012 April: 42 Influenza A H3N2 triple reassortant (swine flu) -Utah (1case); 43 Salmonella Bareilly (tuna) Multi-State Outbreak (20 + D.C.); 44 Fungal Endophthalmitis infections linked to Brilliant Blue-G Dye used for the eyes Multi-State Outbreak (7 states, 34 cases); July: 45 Influenza A H3N2 triple reassortant (swine flu) - Indiana (4cases); 46 Influenza A H3N2 triple reassortant (swine flu) - Hawaii (1) August: 47 Influenza A H3N2 triple reassortant (swine flu) - Indiana (1); 48 Influenza A H3N2 triple reassortant (swine flu) - Ohio (10 cases) September: 49 Influenza A H1N2 triple reassortant (swine flu) Minnesota (3); 50 Multistate (12 States) outbreak of Listeriosis linked to imported Frescolina Brand Ricotta Salata cheese); 51 Novel influenza H1N1 triple re (swine flu) Missouri (1); 52 Multistate outbreak of West Nile Virus (48 States) 21% 10% Event Categories International Travel Chemical Event 6% 2% Foodborne Contaminated Product 61% Total =52 ASPR: Resilient People. Healthy Communities. A Nation Prepared. 17
Events posted on IHR Event Information Site Assessed by WHO July 2007 January 14, 2012 WHO posted 252 events 225 from 110 countries 27 from the U.S. 113 influenza 18 poliomyelitis 520 reports/announcements for 2009 ph1n1
WHO Assessed and Posted U.S. IHR Events, 2007-2012 8 6 4 2 # of IHR events from U.S. assessed by WHO (N=27) 0 2007 2008 2009 2010 2011 2012 1 event each Botulism E. coli (EHEC) Environmental Pollution (Oil Spill) Hantavirus Pulmonary Syndrome Lassa Fever Typhoid Fever West Nile Fever Multiple events Influenza (12) Salmonella (6) Drug Adverse Event s (Heparin, Brilliant Blue G dye)
Immediately Notifiable Conditions* CSTE response to the International Health Regulations Immediate, Extremely Urgent 4 hours notification to CDC Contact Emergency Operations Center Electronic transmission next business day Immediate, Urgent 24 hours notification to CDC Contact Emergency Operations Center Standard electronic transmission (weekly) Standard Electronic transmission (weekly) * CSTE position statement 08-EC-02 modified by 10-SI-02
Background 2009 Pandemic Influenza H1N1
A cluster of oseltamivirresistant ph1n1 infections (H275Y mutation) among patients on an hematologyoncology ward mid-october early-november, 2009
PHEIC Assessment, North Carolina, 2009 Cluster of oseltamivir-resistant ph1n1 infections Is the public health impact of event serious? YES First report of an outbreak of Oseltamivir resistant ph1n1 High risk patients. Several influenza-related deaths Concern of community transmission Event shall be notified to WHO under International Health Regulations
PHEIC Assessment, North Carolina, 2009 Cluster of oseltamivir-resistant ph1n1 infections Is the event unusual or unexpected? Is the public health impact of event serious? YES Yes, unusual Not necessarily unexpected Event shall be notified to WHO under International Health Regulations
PHEIC Assessment, North Carolina, 2009 Cluster of oseltamivir-resistant ph1n1 infections Is the event unusual or unexpected? Is the public health impact of event serious? YES Is there significant risk of international spread? Event shall be notified to WHO under International Health Regulations
PHEIC Assessment, North Carolina, 2009 Cluster of oseltamivir-resistant ph1n1 infections Is the event unusual or unexpected? Is the public health impact of event serious? YES Significant concern regarding sustained community transmission Could lead to international spread. Event shall be notified to WHO under International Health Regulations
PHEIC Assessment, North Carolina, 2009 Cluster of oseltamivir-resistant ph1n1 infections Is the event unusual or unexpected? Is the public health impact of event serious? YES Is there significant risk of international spread? YES YES Event shall be notified to WHO under International Health Regulations
November 25, 2009
IHR Process Outcomes Immediate Action Steps: WHO posted web-advisory on risk and recommendations of immune-comprised persons CDC Epi-Aid requested NC DPH posted Epi-X and a Health Alert (HAN) Recommendations: Suggested changes in treatment recommendations Enhance surveillance and infection control precautions Suggested vaccine prioritization for at risk populations
States with Potential PHEIC Notified to WHO (N = 16) 9 (56%) had no concerns about content 4 (25%) unsure (did not see content) 3 (19%) had concerns Concerns included: Too much detail provided Unclear about how information would be used Confidentiality Would have no say in ultimate determination regarding PHEIC Information submitted violated state s data release policy
Feedback Regarding Notification to WHO (n = 20 instances) Received feedback Yes 3 (15%) No 10 (50%) Unsure 7 (35%) Experienced problem Yes 4 (20%) No 9 (47%) Unsure 6 (32%) Problems encountered Information not kept confidential (3) Information further disseminated without permission (2) Response poorly coordinated (1)
Current Notification Process (Among those with opinion) Satisfied with current process Yes 13 (59%) No 9 (41%) Suggested changes More assurance of confidentiality of information Need to be better kept in the loop about what happens Better understanding of process, distribution, and use of information More communication prior to notification to WHO Feedback on deliberations and determination
Survey Results Familiarity with Notification Requirements Very familiar 12 (24%) Moderately familiar 22 (43%) Somewhat familiar 15 (29%) Not familiar 2 (4%)
Questions? St eve Ost rof f sostroff@verizon.net Katrin S. Kohl kkohl@cdc.gov Aaron Fleischauer aaron.fleischauer@dhhs.nc.gov