Immunizations and Chemoprophylaxis for the Prevention of ...

1 Army Regulation 40 562 BUMEDINST 48 110_IPCG COMDTINST ServicesImmunizations andChemoprophylaxisfor the Preventionof InfectiousDiseasesHeadquartersDepartment s of the Army,the Navy,the Air Force,and the Coast GuardWashington, DC7 October 2013 UNCLASSIFIEDSUMMARY of CHANGEAR 40 562/BUMEDINST 48 110_IP/CG COMDTINST and Chemoprophylaxis for the Prevention of infectious DiseasesThis major revision, dated 7 October 2013--o Changes the regulation title to " Immunizations and Chemoprophylaxis for thePrevention of infectious Diseases" (cover).o Describes the responsibilities of the privileged physician with medicaloversight of any clinic or activity that administers Immunizations (para 1-4c(2)).o Describes the responsibilities of the privileged health care provider, who isunder the direction of the privileged physician of any clinic or activity thatadministers Immunizations (para 1-4c(3)).

2 O Changes a reference to five-injection thresholds to reflect current evidence-based practices (para 2-1e(1)).o Adds a description of procedures for vaccine storage and handling (para 2-3).o Adds a description of military indications for required and recommendedvaccines (paras 4-2 through 4-19).o Makes changes to Chemoprophylaxis recommendations (chap 5).o Adds a description of procedures for documenting Immunizations andimmunization recordkeeping (para B-5).o Establishes and recommends immunization personnel training (para B-6 andtable B-1).o Establishes criteria for determining required Immunizations for militarypersonnel (app D).o Makes administrative revisions (throughout).HeadquartersDepartments of the Army,the Navy,the Air Force,and the Coast GuardWashington, DC7 October 2013 Medical ServicesImmunizations and Chemoprophylaxis for the Prevention of infectious Diseases*Army Regulation 40 562*BUMEDINST *AFI 48 110_IP*CG COMDTINST 7 November 2013H i s t o r y.

3 T h i s p u b l i c a t i o n i s a m a j o This regulation for immuni-z a t i o n a n d c h e m o p r o p h y l a x i s u p d a t e squality standards for immunization deliv-e r y ; e s t a b l i s h e s e l e c t r o n i c i m m u n i z a t i o ntracking systems as the preferred immuni-zation record; provides guidance for losti m m u n i z a t i o n r e c o r d s , i m m u n i z a t i o nc r e d i t f o r p r e - e x i s t i n g i m m u n i t y , a n dcomplying with regulations for vaccinesand other products administered in inves-tigational, new drug status or in accord-a n c e w i t h e m e r g e n c y u s e a u t h o r i z a t i o n ;describes dividing initial entry immuniza-tion into two clusters; and describes therole of the Military Vaccine This regulation applies tot h e A c t i v e A r m y , t h e A r m y N a t i o n a lGuard/Army National Guard of the UnitedStates, and the Army Reserve, unlessotherwise stated.

4 It also applies to the fol-l o w i n g : u n i f o r m e d D e p a r t m e n t s o f t h eNavy, Air Force, and Coast Guard (in-cluding the active and reserve componentso f e a c h S e r v i c e ) ; n o n m i l i t a r y p e r s o n sunder military jurisdiction; selected Fed-e r a l e m p l o y e e s ; s e l e c t e d e m p l o y e e s o fDepartment of Defense contractors; andF a m i l y m e m b e r s a n d o t h e r h e a l t h c a r ebeneficiaries eligible for care within themilitary health care system. This regula-tion is applicable during and exception proponent of this regulation is TheSurgeon General. The proponent has theauthority to approve exceptions or waiversto this regulation that are consistent withcontrolling law and regulations.

5 The pro-ponent may delegate this approval author-ity, in writing, to a division chief withinthe proponent agency or its direct report-ing unit or field operating agency, in thegrade of colonel or the civilian may request a waiver to thisregulation by providing justification thatincludes a full analysis of the expectedbenefits and must include formal reviewby the activity s senior legal officer. Allwaiver requests will be endorsed by thecommander or senior leader of the requ-e s t i n g a c t i v i t y a n d f o r w a r d e d t h r o u g ht h e i r h i g h e r h e a d q u a r t e r s t o t h e p o l i c yproponent. Refer to AR 25 30 for internal control process. Thisregulation contains internal control provi-sions and identifies key internal controlsthat must be evaluated (see appendix E).

6 S u p p l e m e n t a t i o n . S u p p l e m e n t a t i o n o fthis regulation and establishment of com-mand and local forms are prohibited with-o u t p r i o r a p p r o v a l f r o m T h e S u r g e o nG e n e r a l ( D A S G Z A ) , 7 7 0 0 A r l i n g t o nBlvd., Falls Church, VA 22041 improvements. Users areinvited to send comments and suggestedimprovements on DA Form 2028 (Recom-m e n d e d C h a n g e s t o P u b l i c a t i o n s a n dB l a n k F o r m s ) d i r e c t l y t o T h e S u r g e o nG e n e r a l ( D A S G Z A ) , 7 7 0 0 A r l i n g t o nBlvd., Falls Church, VA 22041 5143. AirForce users are invited to send commentsand suggested improvements on AF Form8 4 7 ( R e c o m m e n d a t i o n s f o r C h a n g e o fP u b l i c a t i o n ) t h r o u g h c h a n n e l s t o H e a d -quarters, AFMSA/SGOP, 7700 ArlingtonBlvd.

7 , Falls Church, VA 22041 This publication is availa-ble in electronic media only and is in-tended for command levels A, B, C, D,and E for the Active Army, the ArmyNational Guard/Army National Guard ofthe United States, and the Army Re-serve. Navy/Marine Corps: Ships, units,a n d s t a t i o n s h a v i n g m e d i c a l d e p a r t m e n tpersonnel. Air Force: Active Air Force,the Air National Guard, and Air ForceR e s e r v e . C o a s t G u a r d : A c t i v e C o a s tGuard and Coast Reserves.*This regulation supercedes AR 40 562/BUMEDINST 48 110/CG COMDTINST , dated 29 September 40 562/BUMEDINST 48 110_IP/CG COMDTINST 7 October 2013iUNCLASSIFIEDC ontents (Listed by paragraph and page number)Chapter 1 Introduction, page 1 Purpose 1 1, page 1 References 1 2, page 1 Explanation of abbreviations and terms 1 3, page 1 Responsibilities 1 4, page 1 Chapter 2 Program Elements and Clinical Considerations, page 2 Standards 2 1, page 2 Logistics 2 2, page 3 Storage and handling 2 3, page 3 Hypersensitivity or allergy 2 4, page 5 Immunizing women of childbearing potential 2 5, page 5 Exemptions 2 6, page 6 Immunization and Chemoprophylaxis records 2 7, page 7 Jet-injection immunization devices 2 8, page 8 Emergency response requirements 2 9, page 8 Adverse events 2 10, page 9 Program evaluation 2 11, page 9 Blood donation 2 12, page 10 Chapter 3 Personnel Subject to Immunization.

8 Page 10 Military accessions 3 1, page 10 Military personnel 3 2, page 11 Certain civilian employees 3 3, page 11 Contracted workers 3 4, page 12 Department of Defense, Coast Guard schools, childcare centers and youth programs 3 5, page 12 Other populations 3 6, page 13 Chapter 4 Specific Immunization Requirements for Department of Defense and Coast Guard Personnel,page 13 Civilian applicability 4 1, page 13 Adenovirus types 4 and 7 4 2, page 13 Anthrax 4 3, page 13 Haemophilus influenzae serotype b, commonly called Hib 4 4, page 14 Hepatitis A 4 5, page 14 Hepatitis B 4 6, page 14 Influenza 4 7, page 14 Japanese encephalitis 4 8, page 14 Measles, mumps, and rubella (MMR) 4 9, page 15 Meningococcal 4 10, page 15 Pertussis 4 11, page 15 Pneumococcal 4 12, page 15 Poliomyelitis 4 13, page 15 Rabies 4 14, page 16 Smallpox 4 15, page 16 Tetanus, diphtheria, and pertussis 4 16, page 16 Typhoid fever 4 17, page 17 Varicella 4 18, page 17iiAR 40 562/BUMEDINST 48 110_IP/CG COMDTINST 7 October 2013 Contents ContinuedYellow fever 4 19, page 17 Chapter 5 Chemoprophylaxis , page 18 General 5 1, page 18 Anthrax 5 2, page 18 Group A streptococcus 5 3, page 18 Influenza 5 4, page 18 Leptospirosis 5 5, page 19 Malaria 5 6, page 19 Meningococcal disease 5 7, page 19 Plague 5 8, page 19 Scrub typhus 5 9, page 19 Smallpox 5 10, page 19 Traveler s diarrhea 5 11.

9 Page 19 Chapter 6 Biological Warfare Defense, page 20 Responsibilities 6 1, page 20 Procedures 6 2, page 20 Chapter 7 Vaccines and Other Products in Investigational New Drug Status, page 20 Purpose 7 1, page 20 General guidance on investigational new drug products 7 2, page 20 Health recordkeeping requirements for investigational new drug products 7 3, page 20 Information requirements for investigational new drug products 7 4, page 21 Coordination 7 5, page 21 Chapter 8 Vaccines and Other Products Used Under Emergency Use Authorization, page 21 General 8 1, page 21 Criteria 8 2, page 21 Refusal options 8 3, page 21 Health recordkeeping requirements for emergency use authorization products 8 4, page 21 Information requirements for emergency use authorization products 8 5, page 21 Department of Defense requests for emergency use authorizations 8 6, page 21 Coordination 8 7, page , page for Military Immunization, page and Administrative Exemption Codes, page for Military Personnel, page Control Evaluation Process, page 30 Table ListTable B 1: Training standards, page 26 Table C 1: Medical exemption codes, page 28 Table C 2: Administrative exemption codes, page 28 Table D 1: Immunizations for military personnel, page 29 GlossaryiiiAR 40 562/BUMEDINST 48 110_IP/CG COMDTINST 7 October 2013 Chapter 1 Introduction1 1.

10 PurposeThis publication provides directive requirements for the Military Vaccination Program; establishes general principles,procedures, policies, and responsibilities for the immunization program; and implements military and internationalhealth regulations and 2. ReferencesRequired and related publications and prescribed and referenced forms are listed in appendix 3. Explanation of abbreviations and termsAbbreviations and special terms used in this regulation are explained in the 4. Responsibilitiesa . C o m m a n d m e d i c a l a u t h o r i t y . T h e c o m m a n d m e d i c a l a u t h o r i t y w i l l p r e s c r i b e s p e c i f i c i m m u n i z a t i o n a n dchemoprophylactic requirements for their units per requirements established by this publication and additional guidanceprovided by the appropriate surgeon general or the Coast Guard (USCG), Director of Health, Safety, and Work-Life (USCG, CG 11).