Addressing Latent Tuberculosis Infection Treatment Through a Collaborative Care Model With Community Pharmacies and a Health Department

Bernadette Jakeman, PharmD; Stefanie J. Logothetis, PharmD; Melissa H. Roberts, PhD; Amy Bachyrycz, PharmD; Diana Fortune, BSN; Matthew E. Borrego, PhD; Julianna Ferreira, MSN, MPH; Marcos Burgos, MD

Disclosures

Prev Chronic Dis. 2020;17(2):e14 

In This Article

Methods

The University of New Mexico Health Sciences Research Protection Office institutional review board approved the study protocol. This prospective pilot study included adult patients ≥18 years of age who were diagnosed with LTBI by a physician at the NM DOH. Patients were eligible for study participation if they spoke English or Spanish and were followed by the NM DOH offices in Albuquerque or Santa Fe, New Mexico. Patients also had to be able to take LTBI treatment with weekly combination therapy with 900 mg of rifapentine and 900 mg of isoniazid for 12 weeks. Patients were excluded if they were pregnant, receiving concomitant HIV antiretroviral therapy, or had contraindications to 3HP due to allergy or drug interaction. Eligible patients with newly diagnosed LTBI who were seen at the Santa Fe or Albuquerque departments of health from February 2017 through April 2018 were given the choice to receive usual care through the NM DOH or participate in the study, receiving 3HP with directly observed therapy (DOT) at a participating community pharmacy of their choice.

Before consent, patients were provided with a list of 9 possible pharmacy locations (3 pharmacies in Santa Fe and 6 pharmacies in Albuquerque) and their hours of operation. Study investigators identified and contacted 10 pharmacies as potential pilot sites based on geographical distribution and site diversity. Nine pharmacies agreed to participate. Community pharmacy sites included chain, independent, and hospital outpatient pharmacies, in Albuquerque and Santa Fe, New Mexico (NM). The pharmacies were geographically distributed throughout the cities to provide a variety of pharmacy locations for study participants. Patients were allowed to choose only 1 pharmacy location and could not switch locations after consent. No study incentive was offered to patients. Medications were provided to patients at no charge regardless of study participation. Women of childbearing age were counseled to use a barrier birth control method before enrollment and with rifapentine initiation. Study investigators consented patients for study participation at the NM DOH clinics. Baseline laboratory tests (liver function tests, complete blood counts, comprehensive metabolic panel, and HIV with opt-out option) were drawn at the NM DOH before 3HP initiation. Patient demographics, comorbidities, and additional TB risk factors[1] were collected to characterize the patient population being served.

Before implementation, participating pharmacies (range, 1–3 pharmacists per pharmacy) attended (either in person or via videoconferencing) a 2-hour accredited continuing education training on LTBI treatment held at the University of New Mexico. NM DOH nursing personnel at the participating department of health locations were also included in the training program. The NM DOH TB program medical director, the NM DOH TB program manager/TB nurse consultant, and an infectious diseases pharmacist provided the training for community pharmacies. The infectious diseases pharmacist trained additional pharmacists who joined the project at a later date, using the same training materials.

After consenting a patient for study participation, the patient's prescriptions for rifapentine 900 mg (4 tablets) and isoniazid 900 mg (3 tablets), to be taken weekly with DOT, were faxed to the participating pharmacy with 11 refills (12 doses total of 3HP). The TB physician could adjust the dose for weight. The TB physician could also order pyridoxine (vitamin B6) if appropriate.

The participating pharmacies were responsible for acquiring and storing the LTBI medications according to the state law and pharmacy policy. The cost of the medication varied for each site (~$25–30/week). Grant funds provided pharmacies adequate compensation to cover the cost of the medication and pharmacist time. In addition, telephonic interpreter services, also provided through grant funding, were available for Spanish-speaking patients at all pharmacy locations.

Participating pharmacies followed the NM DOH nursing protocol for LTBI treatment with DOT. Patients picked up their weekly doses at the community pharmacy. At each visit the pharmacist would 1) complete a drug–drug interaction evaluation, 2) screen the patient for 3HP treatment toxicity, 3) screen the patient for symptoms of active TB disease, 4) provide the LTBI treatment medication, and 5) watch the patient take the medication (DOT). Screening questions were adopted from the DOH LTBI treatment protocol. If a patient developed signs and symptoms suggestive of liver or hematologic toxicity, the pharmacist contacted the DOH TB program nurse manager and instructed the patient to hold the medications. Potentially serious ADEs were reported to the NM DOH TB Program and reviewed by the TB physician. Reportable potential ADEs were jaundice, persistent nausea or vomiting, abdominal pain, easy bruising or bleeding, and changes in urine or stool color. Medications could be resumed or discontinued after evaluation by the NM DOH TB program's medical director. Patients could discontinue treatment at the community pharmacy and complete treatment through the NM DOH if closer follow-up was required by the TB physician. Treatment was considered complete if patients received 12 doses. To be consistent with DOH completion rate reporting calculations, patients who did not start therapy were not included in the data analysis.

Continuous variables were described by using measures of central tendency (mean, standard deviation [SD]), and binary and categorical variables were described by using the number of nonmissing and missing observations and the frequency and percentage of responses. Patients receiving treatment were categorized into 2 groups: 1) those receiving the complete 12 doses of treatment and 2) those receiving partial treatment. Statistical differences between the 2 groups were determined using the Student's t test for continuous variables (pooled method for equal variances, Satterthwaite method for unequal variances) and Fisher exact test for binary and categorical variables. All tests were 2-sided and used a significance level of P < .05. SAS statistical software version 9.4 (SAS Institute, Inc) was used to perform analyses.

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