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Chapter 8Advising Travelers With Specific Needs

Special Considerations for US Military Deployments

Alan J. Magill, Michael A. Forgione, Jason D. Maguire, Mark M. Fukuda*

OVERVIEW

The US military, as a matter of policy, follows most of the recommendations in the CDC Yellow Book. However, certain situations apply only to the US military, and some policies or recommendations differ from what is recommended in the Yellow Book for civilian travel. Active-duty military physicians generally manage pre-deployment medicine, but civilian physicians may interact with people who are on reserve status, home on leave, recently discharged from active duty, or veterans. Pre-deployment and post-deployment information, policies, and guidelines for clinicians, service members and their families, and veterans can be found on the Deployment Health Clinical Center website (www.pdhealth.mil).  The purpose of this section is to inform US military medical corps officers, who routinely consult the Yellow Book, about these differences and also make civilian clinicians, who frequently see military personnel, aware of them.

In many countries, one of the largest traveling populations is their military personnel. The military should be considered a special population with demographics, destinations, and needs different from those of civilian travelers. This section focuses on the unique aspects of using pre-travel vaccines and malaria chemoprophylaxis in the military population. The specific examples will be from the US military, but the concepts may be applicable to other militaries. In 2012, approximately 1.5 million US military members were on active duty, and approximately 1.0 million were in the reserve forces.

Several characteristics of the military force differ from those of the civilian population (Table 8-07). In general, the active duty military population is younger, in better health than the population at large, and predominately male.

FORCE HEALTH PROTECTION

Force Health Protection (FHP) is an important concept in military medicine. FHP is defined as all measures taken by commanders, supervisors, individual service members, and the military health system to promote, protect, improve, conserve, and restore the mental and physical well-being of service members across the range of military activities and operations. Delivery of vaccines and the use of malaria chemoprophylaxis agents are 2 aspects of FHP.

Medical interventions for FHP are the responsibility of the unit commander, with advice from the unit medical officer. When pre-deployment vaccines or malaria chemoprophylaxis are indicated, the commander includes such requirements in the mission plan. Service members are then required to receive these interventions under proper medical supervision. If a particular vaccine or drug is medically contraindicated, alternative agents may be employed if they are available. The unit medical officer documents which military personnel have not received standard preventive measures, so these people may receive additional monitoring or treatment if they become ill.

FHP policy positions in the Department of Defense (DoD) are issued as directives and instructions. All directives and instructions can be found online at www.dtic.mil/whs/directives.  The Policy and Program for Immunizations to Protect the Health of Service Members and Military Beneficiaries is found in directive 6205.O2E (September 19, 2006) at www.dtic.mil/whs/directives/corres/pdf/620502p.pdf. Although policy may be made at higher levels in Washington, DC, the final decision to use vaccines or malaria chemoprophylaxis under FHP is made by commanders in the field, guided by their medical staff. In certain circumstances, individual service members may be exempt from vaccination. There are 2 types of exemptions from immunization: medical and administrative. Granting medical exemptions is a medical function that can only be validated by a health care professional. Granting administrative exemptions is a nonmedical function, usually controlled by the person’s unit commander. Further information on exemption from vaccination may be found at www.vaccines.mil/documents/969r40_562.pdf#page=9.

Table 8-07. Differences between military populations and civilian traveling populations

CHARACTERISTIC TRAVEL MEDICINE MILITARY MEDICINE
Primary focus Individual Unit
Goal Optimizing advice and interventions for individual travelers Ensuring mission success; optimizing advice and interventions for each person is difficult
Adherence Strongly encouraged but travelers are free to choose Required; vaccines and malaria chemoprophylaxis are part of Force Health Protection (FHP)
Education One-on-one encounters Unit education
Population Not prescreened; travel health providers see all ages and people with preexisting medical conditions Prescreened; people with serious medical problems are not allowed to join the military or be deployed
Special populations Infants, children, pregnant women, elderly people, people with renal or hepatic impairment Less frequent in military population or deployments
Disease comorbidity Similar to civilian population Limited, generally healthy
Gender 50% male, 50% female 85% male
Unusual activities Adventure activities, such as trekking, climbing, scuba diving, spelunking Housed in barracks or other group settings, aviators, Special Forces, operating complex weapons systems, hostile and extreme environments, stress of combat operations, night operations, and use of night-vision goggles
Duration of use Mostly short term, 2–3 weeks The US military often uses chemoprophylaxis for longer periods of time than do short-term travelers. Many deployments, to Afghanistan for example, are for 1 year or longer.

ROUTINE AND TRAVEL-RELATED IMMUNIZATIONS

DoD policy states that the recommendations for immunization from CDC and the Advisory Committee for Immunization Practices shall generally be followed, consistent with requirements and guidance of the Food and Drug Administration (FDA) and with consideration for the unique needs of military settings and exposure risks. The Military Vaccine Agency (MILVAX) supports all 5 branches of the US Armed Services to enhance military medical readiness by coordinating DoD immunization (vaccination) programs worldwide. A valuable source of service-specific information on immunizations for all branches of the US military is found at the MILVAX website (www.vaccines.mil).

In particular, the quick reference tab of the MILVAX website (www.vaccines.mil/QuickReference) provides an easily accessible and complete source of information with product specifics and policy documents that both military and civilian providers will find useful. DoD and service-specific policies for vaccines and geographic-specific vaccine recommendations can also be downloaded from this site.

GEOGRAPHIC AREAS OF RESPONSIBILITY

The US military issues FHP recommendations based on geographic areas of responsibility (AOR) (www.vaccines.mil/QuickReference). Command and control over US military personnel in each AOR are under a unified combatant command, which is a joint (all branches of the US military) command that provides recommendations for all service members being deployed to that AOR. For example, Afghanistan is in the Central Command (CENTCOM) AOR. All personnel on orders to deploy or travel to Afghanistan should receive the vaccines listed in the “Vaccine Recommendations” tab of the above quick reference web page unless there is a medical contraindication.

MALARIA CHEMOPROPHYLAXIS

Preventing malaria in military units deployed to endemic areas is an essential objective of FHP. Malaria can be prevented through 1) education and training; 2) use of personal protection measures, which include individual bed nets, permethrin-impregnated uniforms, and insect repellents; and 3) use of chemoprophylaxis where indicated. The joint instruction on immunization and chemoprophylaxis stipulates that medical commanders designate trained staff to provide comprehensive malaria prevention counseling to military and civilian personnel considered to be at risk of contracting malaria and that such counseling “include instruction on how to take prescribed antimalarial medications, the importance of compliance with the prescribed medication schedule, information about potential adverse effects, and the need to seek medical care if these adverse effects occur” (www.vaccines.mil/documents/969r40_562.pdf#page=23).

Malaria cases seen in returning US military personnel reflect the current deployments around the world. In 2011, the highest risk was for people deployed in Afghanistan, with exposures to chloroquine-resistant Plasmodium falciparum and P. vivax malaria. There is also risk of P. falciparum malaria for people with frequent training and development missions to sub-Saharan Africa.

Several features of malaria chemoprophylaxis under FHP that are unique to the US military are derived from the activities and stressors of military deployments. When antimalarial drugs are used for chemoprophylaxis as part of FHP, the military can only use FDA-approved chemoprophylaxis agents in accordance with the specific FDA-approved indications. Off-label use of drugs is not allowed when given under FHP. If off-label use is felt to be in the best interest of the person or unit, trained and knowledgeable clinicians must provide one-on-one medical evaluations, document in the medical record the rationale for such use, and provide a by-name prescription for the drug or vaccine to each person.

In September 2009, the Assistant Secretary of Defense (Health Affairs) issued a policy memorandum on the use of mefloquine for malaria chemoprophylaxis throughout the DoD. In chloroquine-resistant areas in which doxycycline and mefloquine are equally efficacious in preventing malaria, doxycycline is the drug of choice for malarial chemoprophylaxis in personnel with a history of neurobehavioral disorders. Those personnel with a history of neurobehavioral disorders who cannot take doxycycline should be prescribed atovaquone-proguanil for travel to chloroquine-resistant areas.

The rationale for recommending doxycycline over mefloquine is as follows:

  • With the increasing recognition of possible neuropsychiatric side effects of mefloquine in some people, new relative contraindications have been added to the product label since 2003. In addition, each person prescribed mefloquine must be given an FDA-approved medication guide. Complying with this guidance requires a one-on-one encounter with a knowledgeable provider, which is not feasible with large deployments.
  • Neuropsychiatric side effects may confound the diagnosis and management of posttraumatic stress disorder and traumatic brain injury, which makes the continued routine use of mefloquine less desirable.

In September 2011, United States Africa Command (AFRICOM) issued a policy change recommending atovaquone-proguanil (Malarone) as the recommended malaria chemoprophylaxis option for all personnel for both short- and long-term deployments in high-transmission areas of Africa. High-transmission areas for the purpose of this policy are defined by the National Center for Military Intelligence and can be found at www.intelink.gov/ncmi/index.php (authorization required). For practical purposes, this includes most of sub-Saharan Africa. For people who are unable to receive atovaquone-proguanil because of intolerance or contraindication, doxycycline is the preferred second-line therapy. Use of mefloquine as prophylaxis is a third-line recommendation for those unable to receive either atovaquone-proguanil or doxycycline. Before prescribing mefloquine for prophylaxis, absolute and relative contraindications as described in the approved product label must be considered.

As a matter of policy, the US military routinely uses primaquine for presumptive antirelapse treatment (PART) in returning military populations to prevent the late relapse of P. vivax malaria or P. ovale malaria. PART is also referred to as “terminal prophylaxis.” In PART, primaquine is given to otherwise healthy people on their departure from an endemic area. Primaquine is used for this indication much more frequently in the military than in most civilian travelers.

The FDA-approved regimen for PART is 15 mg (base) given daily for 14 days. This regimen was approved in 1952 and has not been revisited since. In the intervening decades, an overwhelming amount of data has accumulated to show that the total dose of primaquine to eliminate the dormant hypnozoite stages responsible for late relapses is dependent on the infecting P. vivax strain; therefore, the optimal human dose should be based on weight and adjusted for the infecting P. vivax strain.

In 2003, CDC recommended 30 mg (base) of primaquine daily for 14 days based on available evidence, but the FDA-approved regimen remains the lower dose. Adherence to the daily 14-day regimen is poor unless primaquine is given under directly observed therapy, which is rarely done. As a result of noncompliance and subtherapeutic dosing with the 15 mg (base) for 14 days regimen, periodic outbreaks of relapsed P. vivax malaria occur in returning military personnel. Use of the higher-dose primaquine regimen for PART is now recommended for military personnel. This recommendation is consistent with the spirit of DoD issuance 6200.02 (February 17, 2008), in that the higher-dose recommendation for primaquine when used as PART is “standard medical practice in the United States.”

The most important risk of using primaquine is hemolytic anemia in those who are deficient in glucose-6-phosphate dehydrogenase (G6PD). Current policy is for all US military personnel to be screened for G6PD deficiency on entry into military service. However, some people, such as reservists, may have deployed without testing, or clinicians may not be able to confirm results for all people in a unit requiring PART. Clinicians should be aware that hemolytic reactions to primaquine may occur in those with unrecognized G6PD deficiency.

A recurrent issue for military medicine is the correct timing of primaquine when given as PART in conjunction with the standard chemoprophylaxis drug being taken. Primaquine can be given at any time after leaving an endemic area. For convenience and for enhancing adherence to the 14-day regimen of primaquine, it is often best for military units to prescribe the primaquine in the immediate 2 weeks after deployment. During this time the units are often still at their home base completing their inprocessing before block leave. Once personnel depart on leave, adherence and monitoring for side effects are more difficult.

Under FHP, military personnel are required to take their chemoprophylaxis agents as prescribed to maintain mission readiness. Individual soldiers do not have the right to refuse an order given under FHP. There is great variability in practice as to how seriously individual commanders enforce these policies, however, and continued outbreaks of malaria occur in military populations because of poor compliance.

Differences between civilian and US military use of chemoprophylaxis drugs are summarized in Table 8-08.

Table 8-08. Differences between CDC recommendations and US military’s use of malaria chemoprophylaxis

  CDC RECOMMENDATION US MILITARY POLICY
Choice of malaria chemoprophylaxis agent Chemoprophylaxis guidelines do not recommend one drug versus another, but rather emphasize the goal of individualizing the recommendation for the individual traveler on the basis of past experience, itinerary, possible drug interaction, potential side effects, costs, and medical contraindications such as drug allergies. Individualizing advice and recommendations for large military deployments is rarely logistically possible or feasible. Recognizing this reality, in September 2009, the US military adopted a new policy on the use of malaria chemoprophylaxis in the US military. Doxycycline is now the drug of choice to prevent malaria in deployed US military forces in all areas other than sub-Saharan Africa. In September 2011, AFRICOM policy changed to recommending atovaquone-proguanil for sub- Saharan Africa.
Doxycycline An option for chemoprophylaxis in all areas Recommended first-line chemoprophylaxis in all areas other than sub-Saharan Africa.
Mefloquine An option for chemoprophylaxis in all areas

Mefloquine is not recommended as a primary option. It should be used only in those whose travel requires malaria chemoprophylaxis, who cannot take either doxycycline or atovaquone-proguanil, and who meet all requirements of the current FDA-approved product label.

Atovaquone-proguanil An option for chemoprophylaxis in all areas Atovaquone-proguanil is the drug of choice for sub-Saharan Africa. Atovaquone-proguanil is recommended for those who are intolerant of or who have contraindications to doxycycline in other areas.
Primaquine chemoprophylaxis CDC recommends the use of primaquine as primary chemoprophylaxis in geographic areas with mainly P. vivax malaria. There is no FDA-approved indication for the use of primaquine to prevent malaria. Therefore, the US military cannot use primaquine as a chemoprophylaxis agent under current FHP guidelines.
PART Primaquine at 30 mg (base) for 14 days There is no FDA-approved indication for the use of primaquine at the higher dose of 30 mg (base) for 14 days. However, primaquine is an FDA-approved drug with an indication for PART. The CDC-recommended (higher) dose is recommended, as it is standard of medical practice in the United States.
Abbreviations: AFRICOM, African Command; FDA, Food and Drug Administration; FHP, Force Health Protection; PART, presumptive antirelapse treatment.

UNIQUE NEEDS FOR THE MILITARY

US military personnel may encounter threats, such as biological warfare agents, that are not usually considered for civilian travelers. Vaccines, immunoglobulins, drug prophylaxis, and drug treatment regimens can be given under FHP, but only in accordance with FDA-licensed products and regimens and for FDA-approved indications.

Products not approved by the FDA are given to soldiers only with voluntary informed consent under an institutional review board–approved protocol and in accordance with a current and FDA-approved investigational new drug application.

Only under exceptional circumstances would products not approved by the FDA be given to soldiers without informed consent. This circumstance is governed by emergency use authorization procedures. Section 564 of the Federal Food, Drug, and Cosmetic Act (21 USC 360bbb-3), as amended by the Project BioShield Act of 2004 (Public Law 108–276), permits the FDA commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or US military forces, or when there is a potential to affect national security.

BIBLIOGRAPHY

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  2. Brisson M, Brisson P. Compliance with antimalaria chemoprophylaxis in a combat zone. Am J Trop Med Hyg. 2012 Apr;86(4):587–90.
  3. Carr ME Jr, Fandre MN, Oduwa FO. Glucose-6-phosphate dehydrogenase deficiency in 2 returning Operation Iraqi Freedom soldiers who developed hemolytic anemia while receiving primaquine prophylaxis for malaria. Mil Med. 2005 Apr;170(4):273–6.
  4. Food and Drug Administration. Emergency use authorization of medical products. Rockville, MD: Food and Drug Administration; 2007 [cited 2012 Sep 23]. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm.
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  6. Llanos JK. The reporting and recording of unspecified malaria in the military, 1998–2007. US Army Med Dep J. 2009 Apr–Jun:42–5.
  7. Office of the Assistant Secretary of Defense. Policy memorandum on the use of mefloquine (Lariam) in malaria prophylaxis. Washington, DC: TRICARE Management Activity; 2009.
  8. Townell N, Looke D, McDougall D, McCarthy JS. Relapse of imported Plasmodium vivax malaria is related to primaquine dose: a retrospective study. Malaria J. 2012 Jun 22;11(1):214.
  9. US Africa Command. Health and medical Force Health Protection procedures for deployment and travel. US Africa Command Manual [Internet]. 2010 [cited 2012 Sep 23]. Available from: www.africom.mil/staff-resources/travel-to-africa.
  10. US Department of Defense. Department of Defense directive: Force Health Protection (FHP), no. 6200.04. Washington, DC: US Department of Defense; 2004 [updated 2007 Apr 23; cited 2012 Sep 23]. Available from: http://www.dtic.mil/whs/directives/corres/pdf/620004p.pdf
  11. US Department of Defense. Department of Defense instruction: application of Food and Drug Administration (FDA) rules to Department of Defense Force Health Protection programs, no 6200.02. Washington, DC: US Department of Defense; 2008 [cited 2012 Sep 23]. Available from: http://www.dtic.mil/whs/directives/corres/pdf/620002p.pdf.
  12. US Department of Defense. Unified combatant commands. Washington, DC: US Department of Defense; 2011 [cited 2012 Sep 23]. Available from: http://www.defense.gov/home/features/2009/0109_unifiedcommand/.
  13. Whitman TJ, Coyne PE, Magill AJ, Blazes DL, Green MD, Milhous WK, et al. An outbreak of Plasmodium falciparum malaria in US Marines deployed to Liberia. Am J Trop Med Hyg. 2010 Aug;83(2):258–65.

*The views and opinions expressed in this section are those of the authors and do not represent the official views of the US Department of Defense, The US Army, the US Air Force, the US Navy, the Armed Forces Health Surveillance Center, or the Walter Reed Army Institute of Research.

 
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