Pharmacy-Based Travel Health Services: State Approaches to Prescriptive Authority

Abstract

Pharmacists have provided travel health services in some capacity for more than 25 years. The ability of pharmacists to autonomously prescribe travel medications is growing. Three states (California, Idaho, and New Mexico) allow pharmacists to autonomously prescribe medications for international travel using the Centers for Disease Control and Prevention Yellow Book as a guide. Idaho also allows pharmacists to autonomously prescribe select medications appropriate to domestic travel (motion sickness prevention and Lyme disease prophylaxis), and Florida allows for the prescribing of drugs for motion sickness. Core elements from each state law including education, patient assessment, provider notification, and documentation are reviewed.

Background

Demand for pretravel health consultation, vaccination, and medication services, often simply called “Travel Health,” will continue to grow given the global rise in international travel.¹ Pretravel consultation is recommended for individuals 4 to 8 weeks prior to travel to any international location, especially travel to a developing country.² While the casual reader will equate “travel health” with “tourist health,” it is important to note that people travel internationally for work, to visit family, for education, for philanthropic or mission purposes not traditionally considered when considering tourism. These travelers have a need for travel health services, as much, and sometimes more than, the tourist.

Pharmacists have provided travel health services, in some capacity, for more than 25 years.³ Such services leverage the convenience and accessibility of pharmacists, as well as their immunization administration and medication expertise. Studies have demonstrated that pharmacists provide safe, cost-effective travel health services in accordance with clinical guidelines, and that patients report high acceptance and satisfaction with the service.^3-11 Durham and colleagues⁹ compared travel health services provided by specially trained pharmacists with those provided by primary care providers. Travel Health pharmacists were statistically more likely to provide care consistent with clinical guidelines, including antibiotics for traveler’s diarrhea, antimalarials, and vaccines.

In order for pharmacists to fully provide travel health services, they must have the legal ability to administer vaccines, prescribe certain medications, and order and interpret certain tests.^12,13 Medications indicated for international travel are outlined in the Centers for Disease Control and Prevention (CDC) Health Information for International Travel, commonly referred to as the CDC Yellow Book.¹⁴ This resource also outlines recommended and mandated vaccinations prior to international travel. Medications recommended by the CDC Yellow Book tend to fall in 2 categories: (1) those used for self-treatable conditions and (2) those used for prophylaxis (Table 1).^14,15 In addition, while travel health has focused primarily on international travel, certain medications can also be used to help prevent conditions associated with domestic travel (eg, motion sickness prevention and Lyme disease postexposure prophylaxis).¹⁶ It is important to note that state laws and regulations that rely solely on the CDC Yellow Book address only international travel as travel abroad is the focus of this reference.¹⁴

Table 1.

The Centers for Disease Control and Prevention Yellow Book Categorization of Drugs.

Drug Category	Select Conditions
Self-treatable conditions	Travelers’ diarrhea, jet lag, motion sickness, altitude illness, and respiratory infections
Prophylaxis	Malaria, traveler’s diarrhea, leptospirosis, influenza, and deep vein thrombosis

Most states allow pharmacists to administer vaccines and order tests. The ability of pharmacists to prescribe travel medications is much less common.¹³ While Collaborative Practice Agreements (CPAs) are one pathway that can be leveraged, they do not provide an ideal framework for travel health services. CPAs are an agreement between a pharmacist and physician or other provider, in which a physician delegates certain authority to the pharmacist in a formal protocol. Thus, CPAs require finding a collaborating physician and this permission step may present a barrier to entry with respect to providing travel health services that studies have proven to be safe and effective.^3-11 While CPAs may be feasible in institutional settings and medical clinics, the value proposition of a CPA between a community pharmacist and the offsite provider is less clear, and the incentives may not align as pharmacists may be viewed as competing providers.

This article will review the state laws and regulations that currently allow pharmacists to autonomously prescribe travel medications without need for a CPA and will present core elements as a guide to other states considering allowing this service.

Approaches to Autonomous Prescribing

Four states were identified that allow pharmacists to autonomously prescribe medications appropriate to travel outside of a CPA.¹³ Three states (California, Idaho, and New Mexico) allow for autonomous prescribing for international travel. Idaho also allows for the autonomous prescribing of select medications appropriate to domestic travel. The fourth state, Florida, allows for the autonomous prescribing of antinausea drugs for motion sickness.

California

The California legislature passed Senate Bill 493 in 2013.¹⁷ This bill authorized the creation of an advanced practice pharmacist designation, and separately allowed pharmacists to autonomously prescribe certain tobacco cessation medications, hormonal contraceptives, and “prescription medications not requiring a diagnosis that are recommended by the Federal Centers for Diesease Control and Prevention for individuals traveling outside of the United States.”^17,18

The California State Board of Pharmacy (BOP) finalized international travel health regulations that took effect on June 8, 2017.¹⁹ The regulations (16 CCR § 1746.5) specify that prescription medications “not requiring a diagnosis” are those medications that are either (1) for conditions that are recognized as both self-diagnosable and self-treatable or (2) for the prophylaxis of a condition.²⁰

The California BOP regulations require completion of 4 training programs prior to being able to prescribe international travel medications: (1) an immunization training program, (2) a travel medicine program that is at least 10 hours in length and covers each element of the International Society of Travel Medicine’s Body of Knowledge for the Practice of Travel Medicine, (3) CDC Yellow Fever Vaccine Course, and (4) basic life support certification. In addition, pharmacists must obtain 2 hours of ongoing continuing education(CE) of travel medicine every 2 years. This CE must be separate and distinct from the required immunization CE.

The California BOP regulations require a “good faith evaluation” of the patient prior to prescribing and provide a sample travel history form that pharmacists may adapt.²¹ The sample form asks about the patient’s travel plans, travel history, health history, and current medications. There are additional questions specific to female travelers. The regulations require notification to the patient’s primary care provider, if the patient identifies a primary care provider, within 14 days of the date of prescribing. Last, the regulations specify documentation requirements and require maintenance of the documentation by the pharmacy.

New Mexico

New Mexico state law allows pharmacists to autonomously prescribe certain medications based on written protocols approved by the New Mexico BOP; no CPA is needed for these specific protocols. Current protocols include tuberculin skin testing, tobacco cessation, naloxone, emergency contraception, and vaccinations.^22-25

The vaccination protocol was expanded in August 2015, and now includes travel vaccines and select travel medications.²⁷ Specifically, the protocol allows pharmacists to prescribe certain antimalarials (atovaquone/proguanil, chloroquine, and doxycycline), while excluding others (mefloquine and primaquine). In addition, the protocol enables prescribing of medications for traveler’s diarrhea, including bacterial empiric treatment (ciprofloxacin and azithromycin) and antimotility adjuncts (loperamide). The protocol also expressly excludes injectable immunoglobulins.

The New Mexico protocol includes drug-specific limits for the travel medications. For example, doxycycline “cannot be used in pregnancy or children [less than 8 [years old]” and ciprofloxacin “cannot be used [for travel to] areas with known microbial resistance, cannot be used in pregnancy or children [less than] 18 [years ole], [and] cannot be used in those with a history of quinolone allergy.”

The protocol further specifies that pharmacists must maintain basic life support certification, and pharmacists must maintain records that include patient consent forms, records of prescriber notification, and a record of the prescription order.

Florida

Florida was the first state to grant pharmacists autonomous prescriptive authority for select medications, following the passage of the Florida Self-Care Consultant Law in 1984 by the state legislature.²⁹ The statute created a committee comprised of members from the state boards of pharmacy, medicine, and osteopathic medicine.²⁹ The committee was empowered to create a formulary of drugs that pharmacists could prescribe within certain categories. The committee has met on several occasions, and to date has authorized 15 categories of drugs that pharmacists can prescribe.³⁰

While none of the categories are specific to international travel, there are no antimalarial drugs included, for instance; 2 antinausea medications are included: meclizine (up to 25 mg) and (2) scopolamine (not to exceed 1.5 mg per dermal patch).³⁰ The Florida BOP regulations state that meclizine must be labeled “to advise the patient of drowsiness and to caution against concomitant use with alcohol or other depressants” and excludes patients using a central nervous system depressant. The Florida BOP rules further state that patients provided scopolamine “shall be warned to seek appropriate medical attention if eye pain, redness, or decreased vision develops.”

The addition of motion sickness patches was proclaimed a “victory” in at least one publication, noting that “pharmacists in coastal areas could provide this effective and safe medication for their patients who were going fishing for the day or taking a cruise for a week.”²⁸ The Florida regulations place relatively few restrictions on the prescribing authority. The overlaying statute does prohibit refills from the pharmacist and suggests “appropriate referral to another health care provider” in such circumstances.

Idaho

In 2017, the Idaho legislature passed House Bill 191, which allows the Idaho State BOP to determine which drugs, drug categories, or devices pharmacists can autonomously prescribe, as long as certain criteria are met (eg, no new diagnosis is needed or the condition is minor and generally self-limiting, etc).³¹ The Idaho BOP finalized rules that take effect July 1, 2018, that allow the autonomous prescribing of more than 20 drug and device categories, including select international and domestic travel medications, with no CPA needed.³²

With respect to international travel, the Idaho BOP regulations allow the prescribing of any noncontrolled drug indicated for the patient’s intended destination of travel, using the CDC Yellow Book as a guide.³² The regulations require the pharmacist to complete an accredited continuing pharmacy education or continuing medical education course on international travel medicine, but the rule stops short of delineating specific programs or setting a minimum number of contact hours.

In a separate regulation, the Idaho BOP specifies that Idaho pharmacists can prescribe any Food and Drug Administration–approved drug for motion sickness prevention, not just for international travel. The Board chair noted it would be “arbitrary to allow a pharmacist to provide motion sickness patches for an Idahoan embarking on a Mediterranean cruise but not an Alaskan cruise,” and this drug category was thus listed separately.³³

Last, Idaho BOP rules allow pharmacists to prescribe antimicrobial prophylaxis for the postexposure prevention of Lyme disease after a recognized tick bite. The Infectious Disease Society of America lists 14 states where Lyme disease is common, and an individual traveling from one of those states could receive prophylaxis directly from a pharmacist if they meet other guideline requirements.³²

The Idaho BOP establishes general requirements for the prescribing of the more than 20 drug and device categories listed in its rules. Namely, pharmacists must use a patient assessment protocol “based on current clinical guidelines, when available, or evidence-based research findings.” Moreover, the protocol must specify patient inclusion and exclusion criteria, as well as medical referral criteria. The protocols are to be developed by the prescribing pharmacist and are not provided by the regulatory board. For example, a pharmacist intending to prescribe for Lyme disease prophylaxis would be expected to develop a protocol that addresses doxycycline contraindications, duration of tick attachment, timing of tick removal, and travel to endemic areas, among other parameters linked back to clinical guidelines or evidence-based research.^34-35

The regulations require pharmacists to develop an “appropriate follow-up care plan” in accordance with clinical guidelines. Last, pharmacists must “inquire about the identity of the patient’s primary care provider.” If a primary care provider is identified, the pharmacist is required to notify her/him within 5 days of prescribing any therapy.

Discussion

Four states currently allow pharmacists to autonomously prescribe medications for either international or domestic travel without the need for a CPA. The core elements of these laws are reviewed in Tables 2 and 3.

Table 2.

Core Elements of Autonomous, CDC Yellow Book-Based, Travel Medicine Prescribing Models.

Core Element	California Regulatory Requirements20	Idaho Regulatory Requirements32	New Mexico Protocol Requirements26
Initial education	Must complete: (1) immunization training program; (2) complete a travel medicine program that is at least 10 hours in length and covers each element of the ISTM Body of Knowledge for the Practice of Travel Medicine; (3) CDC Yellow Fever Vaccine Course; and (4) basic life support certification	Must complete an accredited CPE or CME on travel medicine	Must maintain basic life support cardiopulmonary resuscitation (BLS/CPR) certification. Training must occur in person, or “live.”
Continuing education	Two hours on travel medicine every 2 years	N/A	N/A
Clinical guidelines	CDC Yellow Book	CDC Yellow Book	CDC Yellow Book
Patient assessment	Perform a “good faith evaluation” on the travel history. A sample travel history form is provided by the Board.	Must use an evidence-based protocol that specifies patient inclusion, exclusion, and medical referral criteria	Must “follow algorithms,” take patient histories and consult with previous medical providers as appropriate
Included drugs	Drugs for (1) self-diagnosable and self-treatable conditions and (2) prophylaxis of a condition	Drugs that are indicated for the patient’s intended destination	(1) Select antimalarials: atovaquone/proguanil, chloroquine, and doxycycline and (2) select agents for traveler’s diarrhea: ciprofloxacin, azithromycin, and loperamide
Excluded drugs	N/A	Controlled substances	Injectable immunoglobulins and select antimalarials: mefloquine and primaquine
Notification to primary care provider	Within 14 days	Within 5 business days	Must notify the patient’s designated primary care provider (timing not specified)
Documentation	Must maintain a patient medication record in a readily retrievable manner, including clinical assessment and travel medication plan	Must maintain documentation “adequate to justify the care provided” including patient assessment, prescription record, notification, and follow-up care plan	Must maintain consent form, records of notification, and prescription order

Abbreviations: CDC, Centers for Disease Control and Prevention; ISTM, International Society of Travel Medicine; CPE, continuing pharmaceutical education; CME, continuing medical education; BLS/CPR, basic life support/cardiopulmonary resuscitation; N/A, not addressed explicitly in state law.

Table 3.

Core Elements of Autonomous Travel Medicine Prescribing Models Related to Domestic Travel.

Core Element	Florida Regulatory Requirements30	Idaho Regulatory Requirements32
Initial education	N/A	N/A
Continuing education	N/A	N/A
Clinical guidelines	N/A	N/A
Patient assessment	N/A	Must use an evidence-based protocol that specifies patient inclusion, exclusion, and medical referral criteria
Included drugs	Scopolamine not exceeding 1.5 mg per dermal patch; meclizine up to 25 mg	Drugs for motion sickness prevention; antimicrobials for Lyme disease prophylaxis
Exclusions drugs	Only 2 drugs allowed; no refills are allowed	N/A
Notification to primary care provider	N/A	Within 5 business days
Documentation	Must create and maintain “a prescription record in the form required by law”	Must maintain documentation “adequate to justify the care provided” including patient assessment, prescription record, notification, and follow-up care plan

Abbreviation: N/A, not addressed explicitly in law.

California law allows pharmacists to prescribe the broadest range of international travel medications, allowing any drug that can be used for self-treatable and self-diagnosable conditions, as well as prophylaxis, in accordance with the CDC Yellow Book. California, however, restricts prescribing to the CDC Yellow Book, thus currently restricting prescribing for domestic travel conditions. Idaho excludes only controlled substances from the CDC Yellow Book, which limits pharmacist’s ability to prescribe for jet lag (zolpidem) and some traveler’s diarrhea (lomotil). New Mexico has the most limited authority, allowing prescribing of only certain traveler’s diarrhea drugs and some antimalarials. Thus, New Mexico pharmacists are not currently able to autonomously prescribe for other self-treatable conditions such as jet lag, altitude sickness, or respiratory tract infections; nor would they be able to prescribe other agents for prophylaxis, such as for leptospirosis, influenza, or deep vein thrombosis.

Only Florida and Idaho allow pharmacist prescribing of drugs that could be used for domestic travel. Idaho allows the prescribing of any drug indicated for motion sickness prevention; Florida allows prescribing for specific drugs (meclizine and scopolamine) for this condition. Idaho also allows prescribing for postexposure prophylaxis for Lyme disease. While there is a convenient resource that states can point to as guidelines for the prescribing of drugs for international travel, there is not an analogous resource for domestic travel. Additional research and stakeholder input will be important to better define the role of pharmacists in prescribing medications that are appropriately used for domestic travel-related conditions.

In summary, pharmacists have the ability to play critical roles in advising travelers on health issues for pending travel. Four states have recognized the value of pharmacists as autonomous prescribers for certain travel health conditions. Given the safety record of existing pharmacist-run travel health services, additional states may consider pursuing more autonomous authority. States looking to allow autonomous models of pharmacist prescribing for travel medications may consider laws similar to those that have been enacted in California, Florida, Idaho, and New Mexico.