Pharmacist-provided Lyme Disease PEP: Improving Treatment Accessibility

A Rhode Island independent pharmacy is the first in the country offering on-demand Lyme disease post-exposure prophylaxis. Green Line Apothecary, an infectious disease specialist, and a University of Rhode Island School of Pharmacy professor entered into a collaborative practice agreement to accomplish this feat.¹ Pharmacists and physicians across the United States may enter into collaborative practice agreements to provide certain pre-determined regimens to patients meeting the physician’s criteria. Laws governing collaborative practice agreements vary between states; almost every state allows for some manner of collaboration.

This pharmacy’s agreement is founded in a novel study from 2012 (full article text available to APhA members) examining single 200 mg doxycycline doses for Lyme disease post-exposure prophylaxis.² Patients (18 years or older) had a tick embedded for at least 36 hours, removed within 72 hours, without a contraindication to doxycycline.

Borrelia burgdorferi (causative agent of Lyme disease) transmission is uncommon in the first 24 to 36 hours after tick attachment. The study enrolled a paltry number of patients, 8, but each patient reported high satisfaction and no major adverse effects or Lyme disease development.

Concerns about this regimen include prophylaxis failure, unnecessary antibiotic exposure, and the risk of other tick-borne diseases (particularly viral infections).

The patient may develop Lyme disease if postexposure prophylaxis fails. Patient counseling ensuring knowledge about Lyme disease symptoms is critical. A larger New England Journal of Medicine study found a single 200 mg dose prevented objective extracutaneous Lyme disease development or asymptomatic seroconversion.³ A slim 13% of enrolled patients developed skin rashes and flu-like symptoms consistent with Lyme disease. Patients may obtain a standard-of-care doxycycline prescription if symptoms develop.

Doxycycline may cause stomach discomfort, diarrhea, and increased sensitivity to sunlight. The first 2 adverse events are generally mild and less severe than Lyme disease. The riskiest times of the year for sunburns overlap with Lyme outbreaks and active people who spend time outdoors are more likely to be bitten by ticks. Consider whether a park ranger, camp counselor, or landscaper will be able to avoid sun exposure (the answer: unlikely).

Some patients may feel doxycycline’s adverse effects exceed the benefit of prophylaxis. For example, the risk of Lyme disease in the second study’s placebo group was a slight 3.2%. This suggests only 1 in 31 patients would have developed Lyme disease in the active arm anyway. Is a number needed to treat of 31 sufficiently low to justify prophylaxis? This small risk seems like a poor justification for action but (for comparison) less than 1% of unvaccinated polio patients develop paralytic polio. Yet, the World Health Organization is working to drive poliovirus to extinction with universal vaccine coverage in order to eliminate this miniscule risk of disability. Lyme carditis, a possibly fatal complication often requiring hospitalization, occurs in a larger share of patients (1% of reported cases) than paralytic polio among polio patients.⁴ Indeed, patients developing mild to moderate Lyme disease arthritis can undergo a 2-week antibiotic regimen but sudden-onset heart block may rob a patient with carditis of the opportunity.

Pharmacies can send the tick, if recovered, for pathogen testing (mainly B. burgdorferi). Tick recovery is more likely if still embedded upon patient-pharmacist phone or in-person contact. Patients can transport the tick, preferably removed intact, in a sealed plastic bag. Testing is generally intended to positively identify B. burgdorferi but can identify the presence of other pathogens such as the causes of ehrlichiosis, anaplasmosis, babesiosis, Rocky Mountain spotted fever, and viruses. Pharmacists can contact their local, county, and/or state health departments to identify any screening programs for these other infections.

The Powassan, Bourbon, and Heartland viruses are emerging viral tickborne infections as of July 2017. Powassan virus is found in temperate areas of northeast Asia and along the Canada-US border. This distribution overlaps with the areas Lyme disease is endemic. Bourbon virus is named after Bourbon County, Kansas and the Heartland virus (as its name suggests) is present in the south-central US. Lyme disease is most common in the Northeast and Great Lakes regions (i.e. the northeastern quarter of the continental US).

The CDC does NOT advocate antibiotic prophylaxis for any non-Lyme disease tickborne infection.⁵ They recommend doxycycline 200mg to non-pregnant patients eight years or older (4 mg/kg up to 50kg) if:

• No doxycycline contraindication,
• Attached tick is an adult or nymphal Ixodes scapularis (deer or blacklegged) tick,
• Estimated time of attachment is at least 36 hours,
• Prophylaxis started within 72 h of tick removal, AND
• Patient lives or has travelled to a Lyme disease-endemic area (CT, DE, MA, MD, ME, MN, NH, NJ, NY, PA, RI, VA, VT, WI).

Lyme disease post-exposure prophylaxis is a unique opportunity for pharmacists to prevent infection in endemic areas, exercise their license in an innovative manner, and create a niche income stream for their business. Barriers include lack of familiarity with collaborative practice agreements, state-specific restrictions, and professional or corporate inertia.

References

1. Wakefield pharmacy offers preventive treatment of Lyme disease. NBC 10 WJAR web site. http://turnto10.com/features/health-landing-page/wakefield-pharmacy-offers-preventive-treatment-of-lyme-disease. Accessed July 13, 2017.

2. Jackson AN, Orr KK, Bratberg JP, Silverblatt F. Pharmacist initiation of postexposure doxycycline for Lyme disease prophylaxis. JAPhA. 2014;54(1):69-73. doi: 10.1331/JAPhA.2014.13106.

3. Nadelman RB, Nowakowski J, Fish D, et al. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. NEJM. 2001; 345(2): 79-84.

4. What you need to know about Lyme carditis. Centers for Disease Control and Prevention web site. https://www.cdc.gov/lyme/signs_symptoms/lymecarditis.html. Updated July 8, 2016. Accessed July 13, 2017.

5. Tick Bite Prophylaxis. Centers for Disease Control and Prevention web site. https://www.cdc.gov/ticks/tickbornediseases/tick-bites-prevention.html. Updated May 22, 2017. Accessed July 13, 2017.