Summary of the substantive public comments received with embedded CDC responses

1 Public Comments on “Recommendations for postexposure interventions to prevent HBV, HCV, or HIV and tetanus for persons wounded during bombings and similar mass casualty events in the United States --- 2007. Recommendations of the Centers for Disease Control and Prevention (CDC).” Public comments and CDC response: NOTE: when the guidance was posted on 2/7/08 the column headings under “B. Recommended postexposure management by risk category and specific pathogen” were inadvertently shifted. This error was recognized and corrected at 5 PM on 2/12/08. However, some of the public comments were received when this error was still in place. That will be noted in the CDC response to the public comments. PUBLIC COMMENT 1: Received 2/8/08 12:13 PM “I would recommend that Hepatitis A vaccine and/or PEP be considered due to the high possibility that fecal matter would be spread over the area, and could come into contact with nonintake skin or be injected onto surfaces of open wounds during a suicide bombing. Thank you.” CDC RESPONSE 1: The prevalence of HAV infection is very low is the US, less than 4,000 incident cases each year, and there is no chronic carrier state (unlike hepatitis B infection). Therefore, the risk of exposure to HAV is vanishingly small in this situation. The closest parallels can be drawn from situations where exposure to environments potentially contaminated with HAV is likely. Studies (conducted in an era of higher HAV incidence) have shown there is no increase in the prevalence of anti-HAV among sewage workers, and there is no increased risk of HAV infection among flooding victims. Data from serologic surveys of HCW does not indicate an increased prevalence of anti-HAV, and hepatitis A vaccine is not recommended for this group. Considering the extraordinarily small risk of exposure to HAV during a mass casually event, recommendations regarding hepatitis A PEP are not warranted. PUBLIC COMMENT 2: Received 2/8/08 12:45 PM “Is this tied in with the NRF, or is this something CDC is doing on their own?" CDC RESPONSE 2: This CDC guidance document was developed independently by an internal CDC working group in consultation with representatives of the National Association of City and County Health Officials, the Council of State and Territorial Epidemiologists, and the Terrorism Injury Information Dissemination and Education partnership. PUBLIC COMMENT 3: Received 2/10/08 12:48 PM “I do not believe that because of the rare chances that some victims of mass casualty have some communicable virus that everybody involved in the casualty should be given a post exposure prophylaxis. As the name implies it is a post exposure prophylaxis and not a post trauma prophylaxis. We should bear in mind that some of these vaccines have their own side effects which patients may just endure because they want to get well and not because of the of chance that somebody involved in the trauma has the disease and may have infected them. 2 For how long can the patient be exposed to the prophylaxis and what happens when such a person is unfortunate to be involved in a mass casualty every year, while he continually is on it? Let’s bear in mind possibility of resistance building up I would rather pose that post exposure prophylaxis be given only when it is confirmed that some o the victims have any of the viruses in question.” CDC RESPONSE 3: The 3 prior public comments were received before we became aware of and corrected the inadvertent shift of column headings under “B. Recommended postexposure management by risk category and specific pathogen”. We apologize for that error and any confusion that it caused, and cannot determine exactly how it impacted these comments. Fundamentally we agree with the concerns identified by Public Comment 3. It is for this reason that, when the shifted column headers in the management recommendations are corrected, this guidance recommends against attempts to provide postexposure prophylaxis for potential exposure to HIV with rare exceptions. We do recommend providing hepatitis B vaccine and tetanus vaccine whenever blood exposure that could result in infection has occurred and adequate prior immunization cannot be documented because the risks of these vaccines is very low and it will not be logistically feasible to define actual exposure risk prior to immunizing under the mass casualty circumstances for which this guidance would be used. We include the corrected recommended postexposure management below and apologize for whatever confusion our failure to recognize this error created. We anticipate that this brings the recommendations in this table income agreement with the text of the draft guidance and also into agreement with the concerns of Public Commenter 3. “B. Recommended postexposure management by risk category and specific pathogen Risk Category HBV Category 1. INTERVENE HCV CONSIDER TESTING GENERALLY NO ACTION NO ACTION HIV GENERALLY NO ACTION GENERALLY NO ACTION NO ACTION Tetanus INTERVENE Category 2. INTERVENE NO ACTION NO ACTION” Category 3. NO ACTION PUBLIC COMMENT 4: Received 2/11/08 at 10:54 AM: “You guys have done a nice job pulling together a lot of stuff for this….and I support your recommendations (with a few caveats per my comments). It's a grisly topic, but a timely one and these recommendations will be very useful going forward. Thanks for the hard work.” Specific comments were embedded as track changes in the document and include the following substantial concerns: rd Public comment (PC) 4A. “The 3 paragraph in the INTRODUCTION section may be unnecessary.” CDC Response 4A: The paragraph is not essential to the content of the document. However, it does identify for the reader the reasoning and assumptions that influenced decision making by the working group and for this explanatory reason, does add value. 3 PC 4B. “INTRODUCTION, paragraph 6, last sentence: Recommend revise to read “Emergency responders and healthcare providers should consult with their legal counsel for guidance regarding the relevant laws of their jurisdictions in advance of any mass casualty event.” CDC Response 4B: We will incorporate your revision. PC 4C. “BLOODBORNE PATHOGENS OF IMMEDIATE CONCERN, paragraph 1, sentence 1: Recommend revising to read: “Although…, three bloodborne pathogens merit specific consideration in mass casualty situations…” CDC Response 4C: We will incorporate your revision. PC 4D: “BLOODBORNE PATHOGENS OF IMMEDIATE CONCERN, paragraph 2, last sentence: Consider deleting this sentence regarding Hepatitis A virus.” CDC Response 4D: We chose to retain this sentence because questions have repeatedly arisen regarding the risk of hepatitis A in this situation. PC4E: “BLOODBORNE PATHOGENS OF IMMEDIATE CONCERN, paragraph 2, sentence 4: Recommend revise to read: HBV, HCV, and HIV status…will…be unknown, and timely ascertainment may not be practical.” CDC Response 4E: We will incorporate your revision. PC4F: “BLOODBORNE PATHOGENS OF IMMEDIATE CONCERN, Human Immunodeficiency Virus, paragraphs 6 & 7: These last 2 paragraphs are confusing, in that they could be seen as internally contradictory. Clearer guidance should be given and not “wishywashy” exceptions.” CDC Response 4F: In an attempt to clarify the confusion, we have revised the last 2 paragraphs in this section as follows: “In most instances involving bombings or similar mass casualty events, the risk of exposure to HIV-infected materials is likely to be low, and PEP therefore not indicated. On this basis, PEP is not routinely recommended for mass casualty victims in the United Kingdom (5). For the same reason, HIV PEP should not be given universally in mass-casualty settings in the United States unless recommended by the local public health authority. Such instances may occur for mass casualty events in some particular settings judged by public health authorities to be associated with higher risk for HIV exposure (e.g. a research facility that contained a large archive of HIV infected blood specimens). In the rare situation where PEP is used, it should be initiated as soon as possible after exposure and specimens should be collected from the exposed person for baseline HIV testing but PEP should not be delayed for the results of testing. If PEP is used, other laboratory studies are also indicated. Consultation from healthcare professionals knowledgeable about HIV infection is ideal and particularly important for pediatric patients and pregnant women. All persons who have had HIV PEP initiated should be referred to a clinician experienced in HIV care for follow up.” 4 PC 4G: “RECOMMENDED ACTIONS, Risk assessment and corresponding management actions, B. Recommended postexposure management by risk category and specific pathogen: Aren’t these headings shifted? Didn’t you intend the first column of recommendations to apply to HBV, the second to HCV, the third to HIV, and the last to Tetanus rather than the initial to apply to tetanus as originally posted?” CDC Response 4G: Yes, you are correct. Thank you for catching this important error and bringing it to our attention. We corrected these column headers on the posted version at 5 PM on 2/12/08 and apologize for any confusion it created during the public comment period. The table posted on the web now is correct and identical to the correct version incorporated in our response to Public Comment 3 above. The accompanying text addressing this issue was correct throughout the posted public comment period. PC 4H: “RECOMMENDED ACTIONS, Risk assessment and corresponding management actions, C. Actions recommended in response to a pathogen specific management recommendation categories, Bloodborne Pathogens, Hepatitis B Virus, Recommendation: INTERVENE: Healthcare provider Actions, paragraph 2: Should the non-use of HBIG be addressed?” CDC Response 4H: The administration of hepatitis B vaccine + HBIG for PEP is only recommended when exposure is to a known HBsAG positive source. In the cases of a mass casualty event, the source of exposure will be unknown and thus the current recommendation in this document for the use of hepatitis B vaccine alone for PEP is appropriate. PC 4I: “RECOMMENDED ACTIONS, Risk assessment and corresponding management actions, C. Actions recommended in response to a pathogen specific management recommendation categories, Tetanus, Recommendation: INTERVENE: Healthcare provider Actions, paragraphs 1 - 3: The variety of options is very confusing, and in a mass-casualty scenario will be a nightmare with regard to compliance. In the spirit of “keep it simple”, this needs to be distilled down to a single recommendation, and not worry about label indications. Yes, there is a risk of reactogenicity, but I think the focus should be on getting tetanus prophylaxis accomplished for the greatest number of people as quickly and efficiently as possible. Worrying about which formulation to give to whom seems to me to be needlessly complicated and likely to derail the objective.” CDC Response 4I: Thank you for this comment. We agree that clarity is of paramount importance. We have addressed your concerns by placing critical succinct information at the beginning of this recommendation and reformatting what follows to improve clarity of flow, rather than by removing additional detail. The revised section reads as follows: “Recommendation INTERVENE Healthcare Provider Actions Appropriate wound care and debridement are critical to tetanus prevention. Age appropriate vaccines should be used if possible. However, in the mass casualty setting where this may not be possible, any tetanus vaccine formulation may be used, as the tetanus toxoid 5 content is adequate for tetanus prophylaxis in any age group. In this setting, the benefit of supplying tetanus prophylaxis is felt to outweigh the potential for adverse reactions from formulations from a different age indication. Adult patients who cannot readily confirm receipt of a tetanus booster within the past 5 years, and who do not have known contraindication to tetanus immunization, should be immunized with Tdap (or Td if Tdap is unavailable). Adults 65 years of age and older should receive Td. Pediatric patients with uncertain immunization history, and with no known contraindication to tetanus immunization, should receive a tetanus booster according to the following schedule: DTaP if aged less than 7 years Td if aged 7– 10 years Tdap (or Td if Tdap unavailable) if aged 11 years or older. In a mass casualty situation unusually high demand may result in shortages of age-specific vaccine formulations, or logistic considerations may make differentiating patients by age category prohibitive. In the situation where supplies of DTaP are inadequate, providers may consider substituting Tdap or Td for DTaP since the amount of tetanus toxoid in all formulations is adequate for pediatric immunization. Similarly, if supplies of Td are inadequate, providers may consider substituting Tdap for Td for persons aged 65 and older. Pediatric DTaP is generally not indicated in persons aged 7 years and older; the increased diphtheria toxoid content is associated with higher rates of local adverse reactions in older persons (31,32). However, there may not be other options in a mass casualty setting. * TIG may be indicated if completion of a primary immunization series is uncertain for an adult, or prior receipt of age-appropriate immunizations is uncertain for a child. If TIG is in short supply, use of TIG should be reserved first for persons aged 60 years or older as well as immigrants from regions other than North America or Europe. All decisions to administer TIG depend upon the number of victims and the readily available supply of TIG. The recommended prophylactic dose of TIG is 250 units IM for adult and pediatric patients. When tetanus toxoid and TIG are given concurrently, separate syringes and separate sites should be used (33). Persons who receive or are identified as candidates for tetanus toxoidcontaining products or TIG while undergoing evaluation or treatment in immediate response to a mass casualty event should be discharged with referrals for follow-up if possible. Written information on predischarge treatment should be provided to facilitate the ability of primary healthcare providers to evaluate and, if appropriate, complete ageappropriate immunizations or immunization series (See “SAMPLE INFORMATION TO BE PROVIDED TO PATIENTS AT DISCHARGE”, page 50).” PC 4 J: “VACCINE SUPPLY”: This should be revised to read VACCINE AND ANTITOXIN SUPPLY”. CDC Response 4J: 6 We will revise as indicated. PUBLIC COMMENT 5: Received 2/11/08 at 6:29 PM “I am a registered nurse BSN with 11 years Hospice experience. I want to be ready to assist in case of any mass trauma in our area (we are home to an Air Force Base). However, with only Hospice experience, I would not know how to treat the mass causality victim. Where could I go to train for that?” CDC RESPONSE 5: Thank you for your willingness to serve your community in the event of a mass casualty. With rare exceptions, credentialing requirements for hospital staff privileges are not suspended during emergencies. As a result, volunteers who have professional training and experience such as you, but who were not already credentialed with the receiving healthcare facility prior to a mass casualty event, would most likely be best utilized in volunteer roles outside of a hospital during a community crisis. We suggest that you consult with your local and/or state health department or others in your local community who are responsible for planning for emergency responses to identify what roles community volunteers could fill during emergency responses. PUBLIC COMMENT 6: Received 2/12/08 at 8:46 AM “On page 24 - the web address for PEP line is incorrect; it should be http://www.ucsf.edu/hivcntr/PEPline NOT http://www.ucsf.edu/hivcntr/Hotlines/PEPline The phone number is correct” CDC RESPONSE 6: Thank you for your careful review of this document. At the time of this review and comment, both weblinks indicated above were active. However, the one not contained in the original document has become corrupted and the CDC webmaster has (or plans to) discontinue it. The second weblink above will remain in service and is contained in our document. PUBLIC COMMENT 7: Received 2/12/08 at 9:09 AM: “I applaud your efforts to protect mass causality victims from potential blood borne pathogens …hepatitis in all its varieties is common enough to be a valid threat and its relatively small infectious dose and sustained survivability in the environment makes them a valid threat. I would ask that you reconsider the transmission potential of the HIV virus in this scenario as the chemo post exposure prophylaxis procedures are most certainly not user friendly. I would make it available but not make it reflexively mandatory. I appreciate that you are constrained by the legal ramifications of worker's compensation and legal issues long-term. I would bet that the authors of this draft have never taken post exposure prophylaxis themselves. Simply food for thought” CDC RESPONSE 7: Thank you for your review and thoughtful response. We believe your comments are generated by the error in our original web posting that inadvertently had shifted the column headings in the section transmission and are addressed by the correction identified in CDC RESPONSE 3 and CDC RESPONSE 4G above. We apologize for the confusion generated by our error. PUBLIC COMMENT 8: Received 2/12/08 at 1:19 PM 7 “I read your draft recommendations and appreciate the opportunity to comment. The Table on p17 does not appear to be consistent with what is in the text. (Then again, I am reading it after working in the ED last night.) Specifically, category 1 for HBV states "consider testing" but in the text intervention is suggested. For HIV "Intervene" is in the table but text suggests otherwise. Early in the document, mention is made of testing of traumatically implanted bone fragments. I assume from the rest of the paper that this is not recommended practice, but it is not specifically stated that this is not recommended. (You do state that blood exposure should be assumed.) "...mass casualty events in some settings may be associated with higher risk of HIV exposure." What settings and when would pep be recommended?” CDC RESPONSE 8: Re: Table on page 17 – you are correct, the text and the table were not consistent. The text was correct. We had inadvertently shifted the column headers for the page 17 table initially posted (see CDC RESPONSE 3 and 4G above). We apologize for confusion this created. We have corrected the error. The contents of the table on page 17 should now be consistent with the text. Re: testing traumatically implanted bone: You are correct. We do not recommend testing for purposes of guiding medical management of wounded persons. Even for research purposes, the reliability of findings in such circumstances are unknown and interpretation of testing results would be difficult. In response to your question we have inserted the following paragraph on pages 17-18 under RECOMMENDED ACTIONS, Risk assessment and corresponding management actions, C. Actions recommended in response to pathogen specific management recommendation categories, Bloodborne Pathogens: “NOTE: Blast injuries occasionally result in traumatic implantation of bone or other biological material alien to the wounded person. Testing of such matter is not recommended as a useful adjunct for clinical management of wounded persons.” Re: What settings carry higher risk of HIV exposure and when would PEP be recommended: Settings in which HIV exposure risk would be high enough to merit PEP would be rare but an example might include a mass casualty event that involved a laboratory containing an extensive archive of HIV infected blood specimens, or an HIV clinic if large numbers of HIV-uninfected persons were also exposed. Because the rare settings in which HIV PEP would be appropriate are impossible to describe with precision in advance, the guidance recommends that HIV PEP be given universally only in settings where the local public health officials have recommended this based on the unique circumstances of the event. Please note the revision we made in response to Public Comment 4, into which we inserted the following example: “…a research facility that contained a large archive of HIV infected blood specimens”. PUBLIC COMMENT 9: Received 2-14-08 at 9:34 AM “This document goes a long way toward answering common questions we have had to address in the past year’s floods and storm events. We have operated multiple remote and outreach clinics as a response to flooding and Greensburg, but without all the directions contained in this document. It also appropriately addresses issues related to HBV, HCV and HIV which have not been completely addressed previously. The table would make a good stand alone item for providers, as would several of the excerpts which give direct instruction by situation. This approach is much improved, and simpler than previous documents that favored long, verbose dissertations that aren’t functional in an emergency environment. 8 It is notable that the SNS doesn’t include Tetanus and other more commonly used items. Given the relatively high incidence in which Tetanus, and potentially antiviral therapy, are and could be used it should be in the SNS or VMI. This is evident in the events surrounding the last year’s flood and tornado events, much less such massive responses as the post hurricane gulf coast.” CDC RESPONSE 9: Thank you for your critique of both the contents and the format. The Strategic National Stockpile (SNS) contents are determined by multiple factors, including the likely availability of product from commercial sources in event of urgent need. Tetanus toxoid products are readily available from commercial vendors. CDC has worked with the SNS in the past to facilitate transfer of tetanus toxoid products from commercial vendors to areas experiencing acute need due to natural disasters. Decisions on content of the SNS are periodically reevaluated, and we have forwarded recommendations about SNS content received through this process to them for their consideration. PUBLIC COMMENT 10: Received 2-19-08 at 2:54 PM “The board of the National Association of EMS Physicians discussed this document on today's conference call. Overall there are no major concerns - there was only one substantive comment. There seems to be some "waffling" regarding HIV - The reader is initially told that HIV PEP would almost never be needed, but then is told how to do it. Some definition of what types of events might "be associated with a higher risk of HIV exposure," or perhaps a hypothetical example, might help. Are we maybe talking about a case of a suicide bomber who proclaims that he/she is HIV-positive? Or maybe a terrorist event involving a lab that does lots of HIV research?” CDC RESPONSE 10: Thank you for your careful review and comment. Others also found this seeming contradiction confusing. We have attempted to address this by revising the last 2 paragraphs of BLOODBORNE PATHOGENS OF IMMEDIATE CONCERN, Human Immunodeficiency Virus into one revised paragraph and inserting a specific example …“(e.g. a research facility that contained a large archive of HIV infected blood specimens)”. Please see our response to Public Comment 4F above for the complete revision of this section. PUBLIC COMMENT 11: Received 2-17-08 at 8:46 AM “There seems to be a conflict between the table on page 17 and that on page 37. (I assume a clerical error) Page 17 B. Recommended postexposure management by risk category and specific pathogen Risk Tetanus HBV HCV HIV Category 1. INTERVENE CONSIDER GENERALLY INTERVENE TESTING NO ACTION Category 2. INTERVENE GENERALLY GENERALLY NO ACTION NO ACTION NO ACTION NO ACTION NO ACTION NO ACTION Category 3. NO ACTION p 37 TABLE 2. SUMMARY OF RECOMMENDATIONS FOR IMMEDIATE PROPHYLACTIC INTERVENTION p 37 which states for: 9 Category 1, Hepatitis B "Initiate hepatitis B vaccine series, preferably within 24 hours and not later than 7 days, for persons lacking both a reliable history of hepatitis B immunization and a known contraindication." Category 2, Hepatitis B "Same as above" Category 1, HIV "Generally, No PEP warranted. Consider ONLY if exposure is to a known or highly likely HIV-infected source." CDC RESPONSE 11: You are correct. The original posting of this guidance contained a typographical error that resulted in a disparity between the information on page 17 and both the text and the subsequent summary information in Table 2. We became aware of this error through public comments and corrected it by 5 PM on 2/12/08. The information in the text and Table 2 was correct. We apologize for the confusion this error created for those in the public who accessed the web posting prior to correction of this error, and thank you for the effort you took to review and return comments. PUBLIC COMMENT 12: Received 2-19-08 at 2:54 PM “This is wonderfully crafted document. It has been reviewed by my council of state EMS medical directors and the consistent criticism was a request for a summary table of the information on pages 17 forward. Perhaps it could be placed in landscape form and if the two tables were on then copied on to opposite sides of one page and laminated it would be useful as a ready reference. The tables could contain the important information on assigning category and risk for each disease and then the bullet points of treatment. The reader could then go to the full text for more information.” CDC RESPONSE 12: Thank you and your organization for the careful review. We intended Table 2 to serve the purpose that you request, to provide a summary of the information contained in the text starting at page 17-22. Although Table 2 is on the last page of this document for the purpose of this posting, in the published version we will locate it directly after the statement “A summary of recommendations for immediate prophylactic interventions is presented in table 2” on page 22. We have developed another table to summarize the additional information on pages 22 – 29, inserted below. 10 TABLE 3. SUMMARY OF RECOMMENDATIONS FOR ISSUES THAT MAY ARISE IN ASSOCIATION WITH IMMEDIATE PROPHYLACTIC INTERVENTION § ISSUE HBV 1) rely on local public health departments, mutual aid agreements, or commercial vendors 2) If local capacity exceeded, local public health authorities work through established communication channels with CDC and others HCV Pathogen HIV VACCINE SUPPLY SHORTAGE COUNSELING Exposed persons should refrain from donating blood, plasma, organs, tissue or semen. Same as HBV. Same as HBV. In addition, persons known to be exposed to HIV should avoid breastfeeding and organ/tissue donation and take precautions to avoid sexual transmission until HIV infection has been ruled out. 1) HIV PEP should be rarely indicated 2) if indicated, start as soon as possible after exposure. Do not delay for HIV test results. Continue for 4 weeks 3) collect specimens for SPECIAL SITUATIONS HIV PEP is initiated 11 baseline testing: HIV, CBC, LFTs, creatinine, pregnancy test 4) test in accordance with applicable state / local laws 5) consult experts: Local infectious diseases, hospital epidemiology, or occupational health consultant; Local, state or federal public health authorities; PEPline 24-hours/day: 888-448-4911 (preferred) or http://www.ucsf.edu/hivcn tr/Hotlines/PEPline.html Or HIV/AIDS Rx information service http://aidsinfo.nih.gov 6) Continue for 4 weeks 7) discharge with written information, 5-7 day supply of medication, and follow up appointment 8) HIV specialist should reassess within 72 hours Simultaneous HBV vaccine and tetanus toxoid can be administration administered concurrently; use separate syringes and anatomic sites. Administration of Receipt of blood products does not blood products require deferral of vaccination. Pregnancy Pregnancy is not a contraindication to HBV vaccination. Pregnancy is a not contraindication to HIV PEP. Avoid efavirenz if pregnancy suspected. Manage workers according to existing Manage workers Manage workers RESPONDERS AND guidelines for management of according to existing according to existing OTHER occupational exposures. guidelines for guidelines for PERSONNEL management of management of occupational occupational exposures. exposures. Do not use Nevirapine for CONTRAINDICATIO Contraindicated if history anaphylactic allergy to yeast / any vaccine component HIV PEP due to liver NS AND 12 PRECAUTIONS or of serious adverse event after prior receipt of HBV vaccine. toxicity. Do not use efavirenz if pregnancy is known or suspected. INFORMATION SOURCES CDC vaccine website: http://www.cdc.gov/vaccines/ PEP against HBV in occupational settings: http://www.cdc.gov/mmwr/PDF/rr/rr501 1.pdf Same as HBV. Consult experts if possible (see above). PEPline 24-hour/day: 888448-4911 (preferred) or http://www.ucsf.edu/hivcn tr/Hotlines/PEPline.html HIV/AIDS Rx information service http://aidsinfo.nih.gov PEP against HIV in occupational settings: http://www.cdc.gov/mmw r/preview/mmwrhtml/rr50 11a1.htm REPORTING ADVERSE EVENTS VAERS http://vaers.hhs.gov or 800-822-7967 PEP against HIV in nonoccupational settings: http://www.cdc.gov/mmw r/preview/mmwrhtml/rr54 02a1.htm MEDWATCH http://www.fda.gov/medw atch Or 800-332-1088 National Vaccine Health Resources and Services Injury Compensation Adminstration (HRSA) Program 800-338-2382 or http://www.hrsa.gov/vaccinecompensati on/ 13 PUBLIC COMMENT 13: Received 2-20-08 at 3:17 PM “Comments: P. 20 In the rare event that HIV PEP is considered, it should be initiated as soon as possible after exposure. Add “ideally within 2 hours of exposure.” P. 23 Under SPECIAL SITUATIONS In the rare event that HIV PEP is considered, it should be initiated as soon as possible after exposure. Add “ideally within 2 hours of exposure.” P. 27 Under RESPONDERS AND OTHER PERSONNEL, I suggest a stronger statement about pre-event vaccination, such as: “During a mass casualty event, all healthcare personnel, emergency response, public safety and other workers (e.g. construction workers, equipment operators) could potentially become injured while providing assistance. Because,. All healthcare personnel, emergency response and public safety workers may be exposed to blood while providing assistance; therefore, all such personnel should have documentation of 3 doses of hepatitis B vaccine. In order to limit personnel and other resources being diverted to vaccinating responders during a mass casualty event, all such personnel should be up-to-date with their Td vaccination at all times All potential responders should be able to provide documentation of their vaccination status when responding to a mass casualty event.” Thank you for the opportunity to comment.” CDC RESPONSE 13: Thank you for the careful review and thoughtful comments. We have intentionally deferred identifying a specific deadline for initiation of HIV PEP when appropriate while still trying to emphasize the urgency of managing such exposures as rapidly as possible for several reasons. Past efforts to emphasize the urgency of initiating management of such exposures by defining an ideal time frame in which to initiate therapy had unintended consequences resulting in risk managers interpreting the time line as a deadline for initiating therapy and refusing payment for HIV occupational PEP when medication was initiated more than the identified number of hours after exposure. That was not our intent in historic guidance. Further, in the rare instance when HIV PEP would be appropriate in the circumstances of response to a mass casualty event it is possible, perhaps even likely, that more than 3 hours may elapse prior to full evaluation of persons with less immediately life threatening injuries. For this reason we prefer to emphasize that provision of HIV PEP should be a rare exception but, when provided, started as urgently as possible without defining a specific time line. We also appreciated your intent with regard to the stronger statement requiring advance vaccination of all responding personnel, although we have not incorporated it into this guidance. Such a statement exceeds the boundaries of this guidance, which addresses only postexposure interventions to prevent infections in persons wounded during or other wise involved in response to mass casualty events. It is not intended to replace existing guidance that recommends vaccination against hepatitis B for all personnel at risk of occupational exposure to blood and up to date tetanus vaccination for all persons, including those at risk of occupational injury. It also does not extend to address appropriate logistical management of response personnel in mass casualty situations. Further, under the circumstances of an emergency response to a bombing or similar blast resulting in mass casualties, requiring responders to provide on the spot documentation of prior vaccination status and turning away those who cannot would not be feasible and would delay the efficient triage and transport of injured persons to life saving definitive care. In a mass casualty situation resulting from blast events, delay in adequate response to traumatic injury will pose the greatest risk of death. 14 PUBLIC COMMENT 14: Received 2-21-08 at 8:16 PM “The Association of Occupational Health Professionals in Healthcare (AOHP) is a national organization with over 1100 occupational health professionals who work in healthcare settings, primarily hospitals. AOHP’s vision is to be the defining resource and leading advocate for occupational health and safety in healthcare. Our mission is dedicated to promoting the health and safety of workers in healthcare. AOHP appreciates the opportunity to comment on “Recommendations for postexposure interventions to prevent HBV, HC, or HIV infections and tetanus for persons wounded during bombings and similar mass casualty events in the U.S. – 2007”. Each mass casualty event presents its own unique challenges for managing the care of the wounded. The proposed recommendations provide the needed uniform guidance for healthcare providers who will care for casualties and responders to bombings and similar events and are made with the input of both medical and community experts in the field. We commend the authors of this document and would like to provide several comments to include: (1) The summary table for the use of the vaccines can be a quick reference. Perhaps consideration could be given to developing an 8”x11” poster or fact sheet that could be available for clinicians to post or include as part of their emergency response plan. (2) In the final draft, it would be helpful to have the patient follow-up instructions to be formatted on one sheet and it could be recommended that these be printed in duplicate (at individual facilities) so that one copy could remain with the patient’s chart and the other given to the patient for follow-up with the appropriate clinician. (3) A question that came to mind during the review of the document is why are tetanus, tetanus immune globulin and hepatitis B vaccine not included in the Strategic National Stockpile (SNS)? Special purchasing through vaccine manufacturers may not be enough to meet the demand for the vaccine post event. Therefore, given these proposed guidelines, is adding these vaccines to the SNS something that should be reconsidered? CDC RESPONSE 14: Thank you for the careful review and thoughtful comments.We intended summary table 2 to be used as the quick reference you identify. We have further developed table 3 in response to public comment requests from anticipated end users (see response to Public Comment 12) to facilitate quick reference. We will work with MMWR to develop formatting for these tables that facilitates that usage. (1) Thank you for your suggestions. We have revised the header to read “SAMPLE INFORMATION TO BE PROVIDED TO PATIENTS AT DISCHARGE WITH A COPY RETAINED ON THE PATIENT CHART” to emphasize the importance of retaining a Xerox as part of the medical record. (2) We will work with the MMWR editors to develop a 1 page format. (3) As indicated in our response to Public Comment 9, decisions regarding the contents of the Strategic National Stockpile (SNS) are periodically reevaluated. To date, the likely availability of product from commercial sources in event of urgent need and CDC’s ability to work with the SNS to facilitate transfer of products from commercial vendors to areas experiencing acute need has led to decisions to not include tetanus toxoid products, TIG or hepatitis B vaccine in the SNS. We have forwarded recommendations about SNS content received through this public comment process to the SNS for consideration. PUBLIC COMMENT 15: Received 2-25-08 at 7:22 PM due to delay in transmission “The draft looks excellent overall. It would be helpful to clarify that starting PEP does not need to await results of HIV test results. And a few other minor things. I’m glad the Guidelines listed the PEPline as a resource under HIV. I would prefer the phone number as the primary way of reaching PEPLINE, rather than the website, but either way is just fine. It could (maybe should) say “24-hours/day.” And the PEPline can be listed for hep B and C if the Guideliners want, as PEPLINE answers these Qs all the time.” 15 CDC RESPONSE 15: Thank you for the careful review and thoughtful comments. While opportunity for public comment concluded officially at COB 2/22, we continue to consider relevant information received in a timely manner. Re: "it would be helpful to clarify that starting PEP does not need to await results of HIV test results" This is stated clearly in the Introduction, “Bloodborne pathogens”, “HIV”, paragraph 5, sentence 5; again in “Actions recommended in response to pathogen specific exposures”, “Bloodborne pathogens”, “HIV”, “Health care provider actions”, paragraph 3 sentence 3; again in “Special situations”, “When HIV PEP is initiated”, paragraph 1 sentence 3; and again in Table 3 under “Special situations” instructions when HIV PEP is initiated. It was not stated in Table 2, which read only "Generally, No PEP warranted. Consider ONLY if exposure is to a known or highly likely HIV-infected source." The decision to not confuse the reader by augmenting statements that HIV PEP is generally unwarranted in this setting with specific instructions on how to administer it was intentional. However, we have added an additional Table 3 in response to Public Comment 12. Table 3 states clearly that if indicated HIVPEP should …”start as soon as possible after exposure. Do not delay for HIV test results”. We have augmented the appropriate section of table 2 with the following: "In the rare instance when HIV PEP is warranted, see Table 3 for instructions." Re: I would prefer the phone number as the primary way of reaching PEPLINE, rather than the website, but either way is just fine. It could (maybe should) say “24-hours/day.” We are reluctant to remove the website, given the frequency with which phones lines are jammed during emergencies due to unusual levels of traffic. However, we did augment "PEPLINE" with "24-hours/day" in each site where we refer to it and ensured that all references to PEPLINE list the telephone line first and indicate that it is preferred, We also copied the PEPLINE and NIH AIDS line information into the "Information Sources” section under “Links to information about post-exposure prophylaxis against HIV". (It is also included in Table 3 and under “Special situations - When HIV PEP is initiated”.