Coordinating with Public Health on Tuberculosis Testing & Treatment

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1 Coordinating with Public Health on Tuberculosis Testing & Treatment Bernadette Jakeman, PharmD, PhC, BCPS, AAHIVP Associate Professor University of New Mexico College of Pharmacy

2 Objectives 1. Identify the current screening tests for tuberculosis (TB). 2. Describe the differences between active TB disease and latent TB infection (LTBI). 3. Understand the importance of pharmacy performed TB testing and treatment in collaboration with local and state governmental public health agencies. 4. Recognize the need to advocate for enhanced access to public health initiatives in the rural areas. 5. Demonstrate knowledge of how community pharmacies can incorporate TB testing and treatment into their existing practice.

3 Disclosures Some of my research presented was supported by a grant from the NACDS Foundation, a 501(c)(3) not-for-profit charitable organization. NACDS Foundation funds were used to conduct research consistent with, and to advance, its charitable purpose to improve patient health through partnership in research, education and medication management. No other conflicts of interest, financial or non-financial, exist.

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6 Background In 2011 the New Mexico (NM) Department of Health (DOH) was experiencing nursing and funding shortages NM DOH was no longer providing TB testing for employment, school, or immigration requirements NM pharmacy had a number of patients requesting TSTs NMPhA and NM DOH worked together to develop protocol to allow pharmacists to prescribe administer, and interpret TSTs 1,2 1. New Mexico Administrative Code TB Testing. Available at: Accessed July 22, New Mexico TB testing protocol. Available at: Accessed July 22, 2017

7 Stages of Tuberculosis Primary (initial) infection Latent tuberculosis infection (LTBI) Active ( re-activation ) tuberculosis disease

8 Case A 30yo man visits Employee Health for a tuberculin skin test (TST). He is required to have one before starting his new job as a health care worker. He has an 18mm positive reaction to the TST. He has no symptoms of TB, and his chest x-ray findings are normal. He reports that his grandmother past away from tuberculosis. Should this be considered a case of active TB disease? What are the signs and symptoms of pulmonary TB disease? Should this man be considered infectious? Should this patient receive treatment?

9 Differences Between LTBI & Active Disease Latent TB Infection Active Disease Symptoms No symptoms May include: productive cough, hemoptysis, weight loss, fatigue, anorexia, chills, fever, night sweats Infectiousness Cannot spread disease May spread disease Skin test Result Positive Positive Chest x-ray Result Normal Abnormal Smear Result Negative May be positive or negative Culture Result Negative May be positive or negative Treatment Yes, to prevent disease Yes

10 Tuberculosis (TB) in the United States Cases Reported from * No. of cases *As of June 9, Year CDC. Reported Tuberculosis in the United States, Atlanta, GA: U.S. Department of Health and Human Services, CDC, October 2015.

11 Latent Tuberculosis Infection (LTBI) Approximately 13 million people in the US have LTBI 5-10% will develop active TB disease Treatment of LTBI is component of TB elimination strategy in US Houben RMGJ, et al. PLoS Med 2016;13:e

12 Target Groups for Testing Exposure Risk: TB contact Immigration from TBendemic region within 5 years Residents/employees of high-risk congregate settings (e.g., correctional facilities, homeless shelters, healthcare facilities) Progression Risk: Persons with fibrotic lesions on CXR Children <5 years with + TST Underweight/malnourished persons Substance abusers Persons receiving immunosuppressive therapy (e.g., TNF-α antagonists) Persons with certain medical conditions (e.g., HIV, DM, CKD, transplant) Joint Statement by ATS and CDC. Am J Respir Crit Care Med 2000;161:S221.

13 Tuberculosis Screening* 1-4 Mantoux Tuberculin Skin Test (TST) Sensitivity 80% Specificity (-)BCG population ~97% (+)BCG population ~60% Interferon-Gamma Release Assays (IGRAs) Sensitivity 80% Specificity ~95% *Positive tests do not differentiate between active TB disease and LTBI 1. Mazurek GH et al. MMWR Recomm Rep. 2010;59(RR-5): Pai M et al. Ann Intern Med. 2008;149(3): Metcalf JZ et al. J Infect Dis 2011;204:S Sester M et al. Eur Respir J 2011;37:100.

14 Mantoux Tuberculin Skin Test (TST) Skin test that produces delayed-type hypersensitivity reaction in persons with M. tuberculosis infection Uses purified protein derivative (PPD) Administration: Placed on forearm Read within hours

15 Rates 33% to 82% Test Follow Up Rates Populations with low follow up rates: Substance abusers Homeless 1. Luetkemeyer A et al. Am J Respir Crit Care Med 2007;175: Serwint JR et al. Pediatrics 1997;99: Malotte CK et al. Am J Public Health 1998; Fitzgerald JM et al. In J Tuberc Lung Dis 1999;3: Kemper KJ. J Health Care Poor Underserved 1994;5:1. 6. Christy C et al. Arch Pediatr Adolesc Med 1996;150:722.

16 Interpreting the TST >5mm = Positive >10 = positive >15mm = Positive HIV and transplant Immunosuppressive therapy Close contacts X-rays suggestive of untreated TB disease Recent immigration Injection drug use Residents/employees of high-risk congregate settings Diabetes, ESRD, cancer Children <4 or exposed children No risk factors Joint Statement by ATS and CDC. Am J Respir Crit Care Med 2000;161:S221.

17 False-Positive TST Reactions Nontuberculous mycobacteria (NTM) Reactions caused by NTM are usually 10 mm of induration BCG vaccination Reactivity generally wanes over time; positive TST result likely due to TB infection if risk factors are present

18 False-Negative TST Reactions Anergy due to weakened immune system or waning response Recent TB Infection (<10 weeks after exposure) Very young age (< 6 months) Live virus vaccination/illness Overwhelming TB Disease Poor TST administration technique

19 Bacille Calmette-Guérin (BCG) Vaccine Vaccine Live-attenuated strain of Mycobacterium bovis Used in children to prevent disseminated TB infection May result in conversion of TST Effect is minimal, especially after years after vaccination 1,2 TST is not contraindicated in persons who have been vaccinated May consider LTBI diagnosis in patients with TST reaction >10mm 1. Farhat M, et al. In J Tuberc Lung Dis 2006;10: Mancuso JD. Chest doi: /j.chest [Epub ahead of print]

20 Interferon-Gamma Release Assays (IGRAs) Whole-blood laboratory test Antigen specific to M. tuberculosis is added to blood Measures release of INF-gamma produced by the T- cells in response to antigen exposure Patients do not need to return to clinic Two FDA-approved IGRAs QuantiFERON -TB Gold In-Tube test T-SPOT.TB test

21 Case 45 year old male health care worker (HCW), US born QTF-TB test = reactive TST negative for last 10 years No history of know exposure to TB CXR normal No symptoms of TB disease Repeat QTF-TB test negative What is the appropriate management?

22 1. Dorman SE et al. Am J Respir Crit Care Med 2014;189: Zwerling A et al. PLoS ONE doi.org/ /journal.pone Joshi M et al. Ann Am Thoracic Soc doi.org/ /annalsats oc 4. Slater ML et al. Am J Respir & Crit Care Med doi.org/ /rccm oc IGRAS & TST Conversions among HCW in low TB incidence settings Study Population TST Conversion IGRA Conversion Dorman et al 1 US HCW 0.9% QFT = 6.1% T-SPOT = 8.3% Zwerling et al 2 Canadian HCW QFT = 5.3% Joshi et al 3 Arkansas HCW 0.1% QFT = 3.2% Slater et al 4 Stanford HCW 0.4% QFT = 4.4% Most conversions appear to be false-positives because the majority demonstrate reversion upon retesting

23 Test Variability of QuantiFERON-TB Gold Pai M, et al. Clin Microbiol Rev 2014;27:3.

24 TSTs vs IGRAs TSTs IGRAs Advantages Inexpensive (May obtain in a community pharmacy) Disadvantages Requires follow up visit(s) Reader variability 1-3 Two-step testing may be required Cross-reactivity with BCG and other NTM (false-positive) False negatives in ~20% Does not differentiate between active TB disease & LTBI Advantages No follow up visit No interpretation variability Does not cross-react with BCG Results available with 24hr Disadvantages Blood draw Cost? False positives (NTM mycobacteria) False negatives in ~20% Does not differentiate between active TB disease & LTBI 1. Perez-Stable EJ. Am J Public Health 1985:75; Longfield JN. Pediatr Infect Dis 1984:3: Moran-Mendoza O. Int J Tuberc Lung Dis 2013:17:1273.

25 CDC - Testing Preference In general either test is acceptable IGRAs are preferred method of testing for Groups of people who have poor rates of returning to have TST read Persons who have received BCG vaccine TST is the preferred method of testing for Children under the age of 5 Joint Statement by ATS and CDC. Am J Respir Crit Care Med 2000;161:S221.

26 Pharmacy-Performed TB Testing Available in the following states: 1-3 New Mexico Idaho Collaborative practice agreements in other states (e.g. WA) 1. Hecox N, et al. JAPhA 2008;48: Jakeman B, et al. JAPhA 2015;55: Atkinson D, et al. Inov Pharm. 2017;8(2): Article New Mexico Administrative Code TB Testing. Available at: Accessed July 22, 2017.

27 NM Pharmacy-Performed TST Program Goals: Increase testing access, especially in underserved areas Improve public health Target population: Employment School Immigration Optional training for NM pharmacists

28 NM Program Requirements Complete Training Follow protocol for administering TB skin antigen Document prescription and informed consent Report positive results to NM DOH TB Program and patient s PCP 1. New Mexico Administrative Code TB Testing. Available at: Accessed July 22, New Mexico TB testing protocol. Available at: Accessed July 22, 2017

29 NM Program Training Collaboration between NMPhA (NM Pharmacists Association and NM DOH) NMPhA coordinates site, registration, CE, pharmacist trainer(s) NM DOH coordinates TB nurse trainer(s) and provides training materials/tools Provided quarterly with 12 spots/session Components: 1-hour pre-recorded webinar Three-hour class which involves presentation, CDC training film, and practice session 3.0 Contact hours of ACPE-accredited CE

30 Pharmacy Student Training Available in the following states: New Mexico 1 Same training as RPh Idaho 2 Same training as RPh Washington state 2,3 Incorporated 3-hr training into curriculum at the University of Washington and Washington State University 1. Jakeman B, et al. JAPhA 2015;55: Atkinson D, et al. Inov Pharm. 2017;8(2): Article McKennon SA et al. Am J Pharm Educ 2016;80: Bertsch T et al. Abstract presented at AACP 2017.

31 Evaluation of NM Pharmacy-Performed TB Testing Program Jakeman B et al. JAPhA 2015;55:307.

32 Successes of the NM Pharmacy- Performed TB Testing Program 43 pharmacists were trained to administer TSTs, 25 actively testing in eight community pharmacies Over 600 tests were performed in NM community pharmacies School and work were the most common reasons for obtaining TST 71.8% of patients were in rural areas High TST reading follow up rates (92.8%) 18 positive tests (3.1% positivity rate) were identified during the evaluation period Jakeman B et al. JAPhA 2015;55:307.

33 Successes of the NM Pharmacy- Performed TB Testing Program 43 pharmacists were trained to administer TSTs, 25 actively testing in eight community pharmacies Over 600 tests were performed in NM community pharmacies School and work were the most common reasons for obtaining TST 71.8% of patients were in rural areas High TST reading follow up rates (92.8%) 18 positive tests (3.1% positivity rate) were identified during the evaluation period Jakeman B et al. JAPhA 2015;55:307.

34 Community Pharmacy Services Most pharmacists are willing to provide additional services in their communities as long as they receive proper education and training 1-3 Next steps in NM Increase in # trained? Increase in # actively testing? Barrier(s) to incorporating TST into community pharmacies? 1. Eades et al. BMC Public Health 2011;11: Ryder et al. JAPhA 2013;53: Oddis et al. Am J Hosp Pharm 1990;47:185.

35 NM Pharmacist Data 209 pharmacists trained by June 2016 Survey of NM pharmacists (N=94) conducted between June 2016 Oct 2016 Nearly 50% (n=45) of survey respondents are actively testing Logothetis S, et al. ASHP 2016 Midyear Clinical Meeting. Abstract #6-074

36 NM Pharmacist Data >95% of pharmacists agreed /strongly agreed that they felt confident in administering the TST Logothetis S, et al. ASHP 2016 Midyear Clinical Meeting. Abstract #6-074

37 Time Required for Pharmacist-Performed TB Testing (N=45) 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 71.1% 42.2% 35.6% 15.6% 11.1% 11.1% 4.4% 6.70% 2.2% min 6-10 min min min >20 min Time required for initial visit (TST placement & education/counseling) Time required for follow up visit (TST reading & education/counseling) Logothetis S, et al. ASHP 2016 Midyear Clinical Meeting. Abstract #6-074

38 Reasons Pharmacists are not Performing TSTs after Certification (N=49) 70.0% 61.2% 60.0% 50.0% 40.0% 30.0% 24.5% 20.4% 18.4% 20.0% 10.0% 4.3% 4.3% 8.2% 8.2% 8.2% 6.1% 6.1% 0.0% 0.0% Logothetis S, et al. ASHP 2016 Midyear Clinical Meeting. Abstract #6-074

39 Increased Access to Testing 24 participating pharmacy locations between 8/1/14 7/31/16 placed 1916 tests Surveyed convenience sample 160/225 patients who were contacted agreed to participate (75.1% response rate) Results Only 102 (60.35%) had a primary care physician (PCP) 76.9% lived within 5 miles of pharmacy vs 42.9% who lived within 5 miles of PCP 32% received their first TST at pharmacy 18.9% had TST placed and read outside of normal business hours (8am-5pm, M-F) Acosta J, et al. APhA 2017 Annual Meeting. Abstract #377. Research supported by a generous grant from the NACDS Foundation, a 501(c)(3) not-for-profit charitable organization.

40 TB Testing in Community Pharmacies Provides public health service Minimal training required Easy access for patients (ideal in rural areas) Convenient hours Low cost Small time requirement No appointment requirement

41 Next Steps In NM positive tests are reported to DOH and PCP Can we do more?

42 Treatment Regimens for LTBI Drug(s) Duration Interval Isoniazid (INH) 9 months Daily Twice weekly 6 months Daily Twice weekly Isoniazid & Rifapentine (3HP) 3 months Once weekly Rifampin (RIF) 4 months Daily

43 LTBI treatment with INH Only 40-60% of those who initiate treatment for LTBI with isoniazid (INH) for 9 months complete therapy 1-3 Poor adherence Long treatment duration Toxicity 1. Joint Statement by ATS and CDC. Am J Respir Crit Care Med 2000;161:S Menzies D, et al. CMAJ 1999;161: Camins B, et al. JAMA 1996;275:1013.

44 TB Screening & Treatment cascade among HIV-Infected Patients Completed LTBI 57% Indication for TST TST Placed TST Read TST Positive Initiated Tx Completed Tx 70 *TST = Tuberculin Skin Test; Tx = Treatment Diaz A, et al. BMC Infect Dis 2010;10:267.

45 Weekly INH + Rifapentine + DOT for LTBI Outcome 9H* N=3,745 3HP** N=3,986 P-value Treatment completion 2,585 (69.0%) 3,362 (82.1%) < Permanent drug d/c due to an ADE 135 (3.6%) 188 (4.7%) Hepatotoxicity 101 (2.7%) 16 (0.4%) Death 39 (1.0%) 31 (0.8%) 0.22 *9H = Isoniazid 300mg PO daily x 9 months **3HP = Isoniazid 900mg PO weekly x 12 weeks plus rifapentine 900mg weekly x 12 weeks plus directly observed therapy Sterling TR, et al. NEJM 2011;365:

46 LTBI Treatment Completion Rates of Close Contacts Regimen Completed Treatment (%) P-value INH alone 9 months 57 Ref Rifampin alone 4 months INH + RPT for 3 months* 74 <0.001 *INH = Isoniazid; RPT = rifapentine Fiske C, et al. Int J Tuberc Lung Dis 2014:18(4):421.

47 Advantages of 3HP + DOT* Higher completion rates Shorter duration Less hepatotoxicity Given once weekly *DOT important component!

48 LTBI Project in NM Patients are evaluated for active disease at NM DOH Patients who are candidates for 3HP are offered treatment at community pharmacies or DOH Community pharmacies: Provide LTBI treatment with weekly 3HP Provide directly observed therapy (DOT) Evaluate for adverse side effects Evaluate for drug interactions Communicate with NM DOH Document completion/discontinuation with DOH for surveillance *Research supported by a generous grant from the NACDS Foundation, a 501(c)(3) not-for-profit charitable organization.

49 Additional Resources Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection MMWR 2000; 49 (No. RR-6) Recommendations for Use of an Isoniazid Rifapentine Regimen with Direct Observation to Treat Latent Mycobacterium tuberculosis Infection s_cid=mm6048a3_w CDC TB Website - Latent Tuberculosis Infection: A Guide for Primary Health Care Providers

50 Learning Assessment 1. TB testing is not warranted in which population? a. People who have spent time with someone who has TB disease b. People who recently immigrated (<5 years) from a country where TB disease is common c. People previously treated for active TB disease d. Health-care workers who care for patients at increased risk for TB disease

51 Learning Assessment 1. TB testing is not warranted in which population? a. People who have spent time with someone who has TB disease b. People who recently immigrated (<5 years) from a country where TB disease is common c. People previously treated for active TB disease d. Health-care workers who care for patients at increased risk for TB disease

52 Learning Assessment 2. Which of the following TB test(s) is/are preferred for the community pharmacy? a. TB IGRA Interferon gamma release assay b. TST- Tuberculin skin test c. TB tine test d. All of the above

53 Learning Assessment 2. Which of the following TB test(s) is/are preferred for the community pharmacy? a. TB IGRA Interferon gamma release assay b. TST- Tuberculin skin test c. TB tine test d. All of the above

54 Learning Assessment 3. Which of the following factors make community pharmacies ideal for TB testing? a. Low cost b. Accessibility to the community c. No appointment requirements d. A and B e. All the above

55 Learning Assessment 3. Which of the following aspect(s) make community pharmacies a beneficial setting for patients to access TB testing? a. Low cost b. Accessibility to the community c. No appointment requirements d. A and B e. All the above

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