Perspectives: Legal Issues in Travel Medicine

Perspectives: Legal Issues in Travel Medicine

Travel medicine providers—as in other medical specialties—are at risk of legal action. Claims for medical negligence may involve any of the following: 1) failure of duty of care; 2) failure to uphold the standard of practice; 3) care resulting in physical, financial or psychological loss; and 4) failure to reach the standard of care directly caused this loss.
Although travel medicine practitioners come from many backgrounds, in the travel medicine arena they are preventive medicine specialists. As such, in giving advice, they provide education and not generally “hands on” patient care. Although misunderstandings and legal action may occur despite best efforts, certain guidance is helpful.

Communication.

The likelihood of a lawsuit is lessened by good communication between the provider and the traveler patient. All elements of a pretravel consultation must be covered either verbally during the visit or given as written material for the patient to take home. Since time is a limitation, clinics need to provide handouts on how to avoid common health problems not discussed during the consultation. It is also is helpful to provide written information about medications and vaccinations (see below) that are being given or prescribed.

Documentation.

Clinics should have a method for documenting all aspects of the consultation as well as an area within the record for the provider to comment on the patient’s questions or responses to recommendations. Many electronic medical records enable the provider to add items unique to travel health and to add comments regarding the consultation.

Identification of problems.

Providers are encouraged to consult with their risk management personnel or legal advisors in the event of a contentious office visit or exchange after the visit. Good documentation of all communications in a nonjudgmental fashion between traveler patient and provider is critical.

Examples of Legal Issues in Travel Medicine

Prescription Medications

Fluoroquinolones

Fluoroquinolone use is sometimes associated with tendinitis, tendon rupture, peripheral neuropathy, and central nervous system adverse events. Lawsuits regarding these problems continue, and it is unknown whether a single dose of a fluoroquinolone used for the self-treatment of travelers’ diarrhea can lead to such events. Thus, despite the fact that prescriptions come from pharmacies with directions and adverse event information, providers should also discuss potential adverse events with their patients.

Mefloquine

Mefloquine may cause serious neuropsychiatric adverse events, including visual hallucinations, psychosis, insomnia, seizures, nightmares, neuropathies (motor and sensory), and dizziness. These adverse events can persist after discontinuation of the drug. Providers should not prescribe mefloquine to patients with a seizure disorder or a psychiatric disorder (depression, generalized anxiety disorder, psychosis, or schizophrenia). CDC also recommends against its use in patients with cardiac conduction abnormalities. Travelers receiving a prescription for mefloquine should receive a copy of the US Food and Drug Administration (FDA) medication guide (www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf). Because of its low cost and convenient weekly dosing, however, mefloquine remains an attractive option for some travelers. Therefore, providers recommending mefloquine for malaria prophylaxis should document clearly and carefully why they selected this drug over other antimalarial drugs; a notation that the provider reviewed the medical history for potential contraindications should also be included as part of the patient record.

Primaquine and tafenoquine

These drugs may cause potentially fatal hemolysis in G6PD-deficient patients. Thus, clinicians should screen anyone receiving a prescription for either of these medications for G6PD deficiency.

Drug interactions

Drug interactions may occur among medications prescribed for a traveler. Medication reconciliation is an essential part of the travel history. Electronic medical records and other pharmacy aids are useful to alert clinicians of drug interactions in real time, when decisions are being made about travel medication prescriptions. Use fluoroquinolones and macrolides with caution in traveler patients taking other QT interval–prolonging agents. Concurrent use of antibiotics with cholera or oral typhoid vaccines may produce a reduced vaccine immune response. Antibody-containing products may affect live attenuated vaccines.

Off-label use

Sometimes providers find it useful to recommend to travelers medications not approved by FDA for that specific purpose. Examples include use of primaquine alone for malaria prophylaxis and rifaximin to prevent travelers’ diarrhea. However, advisors will sometimes recommend medication uses other than those considered standard of care, and these should be discussed with the traveler prior to prescribing and be documented along with the traveler’s acceptance.

Vaccine Side Effects and Contraindications

To deliver effective and safe vaccinations, travel health providers should review carefully the patient’s past medical history, allergies, and vaccination history. Failure to administer a vaccine correctly can cause an adverse event or result in a traveler acquiring a preventable disease abroad. Travel health providers should discuss and then document any relevant conversations regarding the risk of acquiring a disease, should the patient refuse a vaccine. Travelers known to be immunocompromised, whose immune status may preclude a robust, protective antibody response to vaccination, should be made aware of such.
Serious vaccine-associated adverse events may be due to a variety of causes. Allergic reactions to vaccine components are common. Immunocompromised travelers may particularly suffer adverse events after receiving live vaccines. Eliciting a history of pregnancy, breastfeeding status, immunosuppressive medications, immunocompromised status, and allergies becomes crucial to minimizing vaccine-associated adverse events. Vaccine information statements should be available in the clinic and reviewed with the traveler patient (www.cdc.gov/vaccines/hcp/vis/index.html).
It is essential to document a patient’s history and the data used in decision making, especially when a vaccine is not given or when a provider administers a vaccine despite precautions about its use. It is critical that patients understand (and clinicians document the discussion) about any risks associated with non–FDA-approved dosing schedules, such as those used for the accelerated delivery of some vaccines.

Deep Vein Thrombosis (DVT)

Long-distance travel increases the risk of DVT and pulmonary embolism by approximately 3-fold. The association is stronger with flights of longer duration. Travel medicine providers should counsel patients about DVT and recommend measures to decrease its risk (occasional walking, aisle seat selection, and exercises), and document this discussion in the medical record (see Chapter 8, Deep Vein Thrombosis & Pulmonary Embolism).

Summary and Recommendations

Maintaining a standard of care in one’s practice is important not only for the patient’s protection but for the provider as well. This section gives examples of issues that may bring legal action in the travel medicine arena. Clinic providers should have adequate training in travel medicine and engage in continuing education. It is wise for at least 1 provider at each location to have earned the Certificate in Travel Health (CTH), awarded by the International Society of Travel Medicine (ISTM) upon successful completion of the CTH examination. It is also advisable for providers to remain current in the field by accessing continuing education programs offered by CDC and ISTM.

Bibliography

  1. Burton B. Australian army faces legal action over mefloquine. BMJ. 2004;329(7474):1062.  [PMID:15528599]
  2. Hinrichs-Krapels S, Bussmann S, Dobyns C, Kácha O, Ratzmann N, Holm Thorvaldsen J, et al. Key considerations for an economic and legal framework facilitating medical travel. Front Public Health. 2016;4:47.  [PMID:27066467]
  3. Kahn SR, Lim W, Dunn AS, Cushman M, Dentali F, Akl EA, et al. Prevention of VTE in nonsurgical patients. Chest. 2012 Feb;141(2):e195S–226S.
  4. Kennedy KM, Flaherty GT. Medico-legal risk, clinical negligence and the practice of travel medicine. J Travel Med. 2016;23(5):doi: 10.1093/jtm/taw048.  [PMID:27432905]
  5. Lapostolle F, Surget V, Borron SW, Desmaizières M, Sordelet D, Lapandry C, et al. Severe pulmonary embolism associated with air travel. N Engl J Med. 2001;345(11):779–83.  [PMID:11556296]

Authors

Andrés F. Henao-Martínez, Carlos Franco-Paredes

Notes

Perspectives sections are written as editorial discussions aiming to add depth and clinical perspective to the official recommendations contained in the book. The views and opinions expressed in this section are those of the authors and do not necessarily represent the official position of CDC.