- Email: [email protected]
Evaluation of a pharmacist-performed tuberculosis testing initiative in New Mexico
EXPERIENCE
Evaluation of a pharmacist-performed tuberculosis testing initiative in New Mexico Bernadette Jakeman, Brittni Gross, Diana Fortune, Sarrah Babb, Dale Tinker, and Amy Bachyrycz
Bernadette Jakeman, PharmD, PhC, AAHIVP, BCPS, Assistant Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM
Abstract Objective: To report experiences of the New Mexico pharmacist tuberculosis (TB) testing program.
Brittni Gross, Student Researcher, College of Pharmacy, University of New Mexico, Albuquerque, NM
Setting: Community pharmacies in New Mexico interested in participating in the TB testing initiative from March 2011 to August 2013.
Diana Fortune, BSN, TB Program Manager, New Mexico Department of Health, Santa Fe, NM
Practice innovation: To expand accessibility of TB testing, New Mexico pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011. To receive this special prescriptive authority, pharmacists had to complete a New Mexico Department of Health training program in accordance with the Centers for Disease Control and Prevention guidelines.
Sarrah Babb, BS, Student Researcher, College of Pharmacy, University of New Mexico, Albuquerque, NM
Evaluation: Data were collected on the number of TSTs performed and the TST reading follow-up rate. Patient data collected were demographic information, reason for obtaining a TST (e.g., immigration, school, or work), TB risk factors, and TST results. Results: In New Mexico, 43 pharmacists were certified for TB testing during the evaluation period, 25 of whom were actively prescribing and performing TB testing at eight community pharmacies. There were 606 tests administered to 578 patients; 70.9% women, median age 31 years (4–93 years). Employment and school were the main reasons for obtaining a TB test. A total of 578 of 623 (92.8%) patients followed up to have their TSTs read. A total of 18 positive tests (3.1% positivity rate) were identified and appropriate referrals were made.
Dale Tinker, BA, Executive Director, New Mexico Pharmacists Association, Albuquerque, NM Amy Bachyrycz, PharmD, Assistant Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM Correspondence: Bernadette Jakeman, PharmD, PhC, AAHIVP, BCPS, College of Pharmacy, University of New Mexico, 1 University of New Mexico, MSC 09 5360, Albuquerque, NM 87131; bjakeman@salud. umn.edu Previous presentation: American College of Clinical Pharmacy Annual Meeting, October 14, 2013, Albuquerque, NM Disclosure: The authors declare no relevant conflicts of interest or financial relationships. Received June 20, 2014. Accepted for publication October 10, 2014.
Conclusion: New Mexico expanded the scope of practice for pharmacists. Pharmacist-performed TB testing had a valuable public health benefit. TB testing follow-up rates at community pharmacies in New Mexico were high, most likely due to convenient hours, accessible locations, and no required appointments. J Am Pharm Assoc. 2015;55:307–312. doi: 10.1331/JAPhA.2015.14141
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ates of tuberculosis (TB) disease, caused by Mycobacterium tuberculosis, in the United States are decreasing.1,2 Despite this trend, TB remains one of the world’s leading causes of death.3 Therefore, treatment of TB infection is essential in controlling and eliminating the disease in the United States.2,4 Early identification of people who have been infected is key to preventing progression to active TB and transmission throughout the population.2,5 Published reports of pharmacist-performed TB testing are limited. To expand the accessibility of TB testing in New Mexico, pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011.
Objective The objective of this report is to describe experiences of the New Mexico pharmacist TB testing program. We describe the New Mexico Department of Health (DOH) TB testing certification and training, and report data on persons using pharmacist-performed TB testing services in community pharmacies.
Setting New Mexico DOH Clinics offered TB testing as a regular component of their health care services until state budget concerns affected their ability to provide the service in 2008 and 2009. The DOH limited testing to TB contacts, high-risk individuals (e.g., patients with human immunodeficiency virus [HIV] infections), and individuals with symptoms of active TB. New Mexico pharmacists were interested in providing testing services for individuals that needed testing for other reasons (e.g., school, work, immigrant status). However, a prescription for the service was necessary.
Key Points Background: ❚❚ ❚❚
Treatment of tuberculosis (TB) infection is essential in controlling and eliminating the disease in the United States. Published reports of pharmacist-performed TB testing are limited.
Findings: ❚❚ ❚❚ ❚❚
Between March 2011 and August 2013, 606 tests were successfully administered by pharmacists to 578 patients Testing follow-up rates were high at 92.8%, and the test positivity rate was 3.1% in this low-risk cohort. Expanding the scope of practice of pharmacists to include tuberculosis testing provides a valuable public health service.
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To expand the accessibility of TB testing, New Mexico pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011 under regulation 16.19.26.12.6 The testing protocol is provided in Appendix 1, available on JAPhA. org in the Supplemental Content section. Chain and independent community pharmacies in New Mexico that were interested participating in the TB testing initiative were offered training and certification for their pharmacists. A total of 43 pharmacists were trained and certified for TB testing; 25 pharmacists actively prescribed and administered TSTs in community pharmacies during the study period. Data were collected from a total of eight different community pharmacies, including six chain pharmacies and two independent pharmacies, from March 2011 to August 2013. Tests were performed in both urban (Albuquerque, n = 163) and rural New Mexico (Roswell, n = 153; Carlsbad, n = 262).
Practice innovation The New Mexico Pharmacists Association worked with the New Mexico DOH to develop a protocol allowing pharmacists to prescribe and provide TB testing in New Mexico community pharmacies. The protocol received approval from the New Mexico Board of Pharmacy, New Mexico Medical Board, and New Mexico Board of Nursing, as required by statute. The new law did not require pharmacists to obtain this certification as part of their licensure. But pharmacists who were interested in obtaining certification to provide TB testing services were required to complete comprehensive training on how to prescribe, administer, read, and interpret the TST. Training, as outlined by the Centers for Disease Control and Prevention (CDC), was provided by registered nurses specializing in tuberculosis at the New Mexico DOH. The training consisted of a 1-hour self-study webinar, “Understanding the Tuberculin Skin Test: A Primer for non-TB Staff” supported by Heartland National TB Center, one of five regional training and medical consultation centers in the United States funded by the CDC and supported by a division of TB Elimination in conjunction with the New Mexico DOH and the New Mexico Pharmacists Association. The webinar is followed by a live 4-hour practicum that involved a handson training and skills demonstration. ACPE credit was available for the training. To rule out false-negative results, pharmacists who received the training were also instructed on how to identify patients who met the criteria for the two-step TST test. Some individuals infected with M. tuberculosis may have a negative reaction to the TST if many years have passed since they became infected.7 These individuals may have a positive reaction to a subsequent TST because the initial test stimulated their ability to react to Journal of the American Pharmacists Association
PHARMACIST TUBERCULOSIS TESTING PROGRAM EXPERIENCE
Figure 1. Patients requesting TSTs from pharmacists Abbreviation used: TST, tuberculin skin test.
the test. This is commonly referred to as the “booster” reaction and may incorrectly be interpreted as a skin test conversion. Booster rates have been reported as high as 14.2%.8 For this reason, the “two-step method” is recommended at the time of initial testing for individuals who may be tested periodically (e.g., health care workers).7
Evaluation This project was approved by the institutional review board at the University of New Mexico Health Sciences Center. Data were collected from participating community pharmacies in New Mexico that performed TB testing from March 2011 to August 2013. Data on pharmacist training were obtained from the New Mexico DOH training records. Pharmacist, pharmacy, and patient data were collected from the pharmacy testing consent forms completed at the time of testing in the community pharmacy. Each pharmacy developed its own TST consent forms based on the New Mexico DOH consent form, which is provided in Appendix 2, available on JAPhA.org in the Supplemental Content section. Minimal marketing was done during the data collection period and was left up to the individual participating pharmacies. Some Journal of the American Pharmacists Association
techniques that were used, based on area and need, included physician detailing, radio advertisements, wordof-mouth, in-store signage, electronic reader boards, and informational letters about the program to profit and nonprofit local universities. All patients who requested a TST in a community pharmacy during the evaluation period were included for assessment. Pharmacy data collected included the number of TSTs performed and the TST reading follow-up rate. Patient data collected included demographic information, reasons for obtaining the TST (e.g., immigration, school, or work), TB risk factors, and TST results. Patients of any age, who received a TST from a pharmacist in a New Mexico community pharmacy during the study period were evaluated. Patients with no follow-up or inappropriate follow-up, defined as a TST reading less than 48 hours or more than 72 hours after placement, were excluded from the analysis.
Results
Patient data Of 626 patients requesting TSTs at participating community pharmacies during the evaluation period, 3 did j apha.org
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Table 1. Characteristics of patients (n = 578) receiving pharmacistperformed tuberculin skin test in community pharmacies Characteristics Age, median (range) Gender Men and boys Women and girls Unknown Reason for obtaining test Employment School Immigration Other Unknown Patient medical history Past tuberculin skin test Positive Negative None Unknown Previous treatment of latent tuberculosis infection Yes No Unknown
No. (%) 31 (4–93) 146 (25.3) 410 (70.9) 22 (3.8) 156 (27.0) 91 (15.7) 2 (0.4) 33 (5.7) 296 (51.2)
13 (2.2) 122 (21.1) 179 (31.0) 264 (45.7) 1 (0.2) 249 (43.1) 328 (56.7)
Previous treatment of active tuberculosis Yes No Unknown
2 (0.4) 255 (44.1) 321 (55.5)
Past Bacillus of Calmette and Guerin vaccination Yes No Unknown
5 (0.9) 237 (41.0) 336 (58.1)
Current tuberculosis-like symptoms Yes No Unknown
5 (0.9) 499 (86.3) 74 (12.8)
Tuberculosis risk level High risk (n = 11) Organ transplant Recent contact with active case Immunosuppressed Moderate risk (n = 175) Immunocompromising medical condition Minor exposed to active case Injection drug use Correctional facility employee Health employee Mycobacteriology lab employee Recent travel in high-risk setting Other
1 (0.2) 2 (0.3) 8 (1.4) 29 (5.0) 3 (0.5) 1 (0.2) 4 (0.7) 115 (19.9) 1 (0.2) 9 (1.6) 6 (1.0)
not have the test performed, 45 were excluded, and 578 patients met the inclusion criteria during the evaluation period (2011, n = 131; 2012, n = 273; 2013, n = 174). In all, 45 patients were excluded because of no or inappropriate follow-up (Figure 1). 310 JAPhA | 5 5:3 | M AY /JUN 2 0 1 5
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Patient demographics are listed in Table 1. Results for some patient data could not be collected because of incomplete consent forms. These data are reported as unknown. Data on patients’ place of birth were not collected. Of the 578 patients included in the data analysis, 70.9% were women or girls, and the median patient age was 31 years (range, 4–93 years). Employment and school were the main reasons for obtaining a TST test. Patient TB risk level was determined by the presence of any of the qualifying factors from each category (Table 1). The majority of patients receiving TSTs in community pharmacies were low to moderate risk. Only 11 (1.9%) patients were identified as high-risk. Of the available data, there were no patients who were high risk due to HIV infection or a history of fibrotic changes on X-ray images. Test results A total of 606 TSTs were prescribed and administered by New Mexico community pharmacists to 578 patients. None of the 28 patients receiving a two-step TST had positive results. No adverse drug events were reported. A total of 18 of the 578 (3.1%) patients had a positive TST result. Of these 18 patients who had a positive TST, 7 were identified as low risk, 10 were identified as moderate risk, and 1 was identified high risk, making the TST positivity rate per risk group 1.7% (7/392), 5.7% (10/175), and 9.1% (1/11), respectively. Positive results were reported to the New Mexico DOH and to the patients’ primary care provider (PCP), if a PCP was identified by the patient. The New Mexico DOH was responsible for patient follow –up, and treatment for TB infection was given if indicated. Of the 18 patients with positive TSTs, none was determined to have active TB disease. None of the patients with a positive TST received treatment for latent infection during the study period. Of note, there was a nationwide shortage of the first-line antitubercular medication isoniazid (INH) during the study period. Because of this shortage, the New Mexico DOH reserved INH for treatment of patients with active TB disease or those patients who were considered high risk for progression to active TB disease, including recent contacts with active TB cases, HIV-positive patients, and patients receiving tumor necrosis factor alpha inhibitors. At the end of the study period there were no cases who had progressed to active TB disease. Follow-up Of the 623 patients who received a TST at a New Mexico community pharmacy, 578 (92.8%) had appropriate follow-up. These patients were included for additional analysis. Of the patients who were excluded from analysis, 3.2% had inappropriate follow-up time and 4% did not return to have their TSTs read. Journal of the American Pharmacists Association
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Discussion In 2011, New Mexico expanded the scope of practice for pharmacists to include prescribing, administering, reading, and interpreting TSTs. This regulation has been and continues to be successful, training a large number of pharmacists and reaching many patients in both urban and rural New Mexico. The number of pharmacists completing the training and administering tests has increased since 2013. Currently, 155 pharmacists have completed the certification training, with more training classes scheduled. Demand will also likely increase as patients become aware that pharmacists can provide this service. The scope of practice for pharmacists continues to expand and TB testing provides a great opportunity for pharmacists to have a positive effect on public health. Most pharmacists are willing to provide additional services in their communities as long as they receive proper education and training.9,10 While other options are available for TST services, the community pharmacy setting is ideal, with easy accessibility, extended hours, no required appointments, and pharmacist-provided education. This was evident in our report, with high follow-up rates of 92.8% seen at New Mexico community pharmacies. Follow-up rates range significantly between patient populations and countries.11–14 One of the disadvantages of the TST is the requirement to have the test read within 48 to 72 hours of placement due to the delayed-type hypersensitivity reaction. Patients often do not have the test read within the appropriate time. In a study by Serwint and colleagues, the TST reading return rate for 1,433 children at a pediatric clinic in Baltimore, MD, was 40%.12 In two additional studies that included injection drug users, TST follow-up rates were as low as 33% to 43%. However monetary incentives significantly improved return rates.13,14 The patients in our report who did not follow-up were not called by the pharmacies to determine the cause for inappropriate follow-up. It is unclear if this was to the result of other conflicts, poor patient education, or communication barriers. Even though follow-up was high, education regarding follow-up should be reinforced with all patients receiving TSTs. The price for the test was determined by participating pharmacies based on their individual costs. Patients were charged during initial test placement. Most insurance carriers do not cover TSTs, so patients were charged out-of-pocket costs for these tests. Community pharmacy prices for the TST (typically about $30) appeared to be lower than prices encountered at private clinics (e.g., travel clinics, ranging between $70 and $150). Most primary care providers in New Mexico do not provide the TST, because of their inability to bill insurance for the service. The New Mexico DOH offers TSTs at no cost to high-risk patients (e.g., HIV-positive patients). Despite Journal of the American Pharmacists Association
the out-of-pocket costs, patients in our study used this service at community pharmacies. Provision of TST services was successfully incorporated into the daily workflow in participating New Mexico community pharmacies. A TST pilot study in Washington state also found that implementing TB testing did not impede work flow.15 Workload issues are always a concern in community pharmacies, but many community pharmacies are exploring fee-for-service options to diversify revenue sources. The TST is a feasible service, requiring approximately 10 minutes to prescribe, administer, read, and interpret. During the evaluation period, pharmacists reported less than 1 additional prescription per day. Most pharmacist liability insurance policies cover activities that are within the scope of practice. Because TB testing was approved as part of the pharmacist’s scope in New Mexico, the practice was covered by the liability policies of participating pharmacists. No increase in insurance premiums was seen based on the expanded scope of activities related to TB testing. Other states, especially those with shortages of health professionals or other access issues in rural areas, should consider passing a similar law or implementing a standing physician order for TSTs, similar to what has been done for immunizations. Other issues to consider when implementing this program include: product considerations (e.g.., multi-dose vials expire 28 days after first use), training of sufficient number of pharmacists to ensure that trained pharmacists are available for followup TST readings, and company support to ensure that pharmacists have appropriate time and resources to provide this service. With pharmacists providing these public health services in the community, access is improved, which may allow us to identify infected patients earlier. The TST positivity rate observed in this cohort was 3.1%, even with the majority of patients meeting the low-risk criteria. Pharmacists were able to easily contact the New Mexico DOH TB program regarding positive cases to ensure appropriate follow-up care.
Limitations While this article offers important information regarding pharmacist-prescribed and -administered TSTs in a diverse population, our assessment is subject to several limitations. While demographic and characteristic data were collected, the forms were not completed for a large proportion of patients. Despite high follow-up rates, we were unable to determine additional barriers for patients who did not return for TST reading as scheduled. Marketing efforts were not evaluated. It is unclear if this would be required and what the potential costs would be. Despite these limitations, this is the first study evaluating pharmacist-prescribed and -performed TSTs. This study provides valuable information to other pharj apha.org
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macists who are interested in developing and providing this service in this or other states. The results give useful information on accessibility, TST positivity rates, and follow-up rates, and also demonstrate that there is a demand and a need for this service.
Conclusion New Mexico expanded the scope of practice for pharmacists. Pharmacist-performed TB testing had a valuable public health benefit. Follow-up rates at community pharmacies in New Mexico were high, most likely because of convenient hours, accessible locations, and no required appointments. This service could be especially beneficial in states with shortages of health professionals or other access issues in rural areas.
References 1. Centers for Disease Control and Prevention. Tuberculosis. Basic TB facts. http://www.cdc.gov/tb/topic/basics/default.htm. Accessed June 18, 2014. 2. Centers for Disease Control and Prevention. Trends in tuberculosis—United States, 2011. MMWR Morb Mortal Wkly Rep. 2012;61(11):181–185. 3. The Henry J. Kaiser Family Foundation. U.S. global health policy fact sheet. The global tuberculosis epidemic, June 2010. http://www.kff.org/globalhealth/upload/7883‐02.pdf. Accessed March 7, 2013. 4. Geiter LJ, Gordin FM, Hershfield E, et al. Targeted tuberculin testing and treatment of latent tuberculosis infection: ATS/ CDC Statement Committee on latent tuberculosis infection membership list, June 2000. MMWR Morb Mortal Wkly Rep. 2000;49(RR06):1–54. 5. Centers for Disease Control and Prevention. A strategic plan for the elimination of tuberculosis in the United States. MMWR Morb Mortal Wkly Rep. 1989;38(S-3):1–25.
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6. Occupational and Professional Licensing: Pharmacists. Pharmacist Prescriptive Authority. http://nmcpr.state.nm.us/nmac/ parts/title16/16.019.0026.htm. Accessed June 18, 2014. 7. Centers for Disease Control and Prevention. Latent tuberculosis infection: a guide for primary health care providers. http://www. cdc.gov/tb/publications/ltbi/pdf/TargetedLTBI.pdf. Accessed June 18, 2014. 8. Kim SY, Park MS, Kim YS, et al. Tuberculin skin test and boosted reactions among newly employed healthcare workers: an observational study. PLoS One. 2013;8(5):e64563. doi: 10.1371/ journal.pone.0064563. 9. Eades CE, Ferguson JS, O’Carroll RE. Public health in community pharmacy: a systematic review of pharmacist and consumer views. BMC Public Health. 2011;11:582–595. 10. Oddis JA. Revisiting “the strengths of pharmacy”: the 1953 Remington Medal address. Am J Hosp Pharm. 1990;47:1985– 1988. 11. Macpherson P, Houben R, Glynn JR, et al. Pre-treatment loss to follow up in TB patients low and lower middle income countries and high burden countries: a systematic review and meta-analysis. Bull World Health Organ. 2014;92:126–138. 12. Serwint JR, Hall BS, Baldwin RM, et al. Outcomes of annual tuberculosis screening by Mantoux test in children considered to be at high risk: results from one urban clinic. Pediatrics. 1997;99:529–533. 13. Malotte CK, Rhodes F, Mais KE. Tuberculosis screening and compliance with return for skin test reading among active drug users. Am J Public Health. 1998;88:792–796. 14. FitzGerald JM, Patrick DM, Strathdee S, et al. Use of incentives to increase compliance for TB screening in a population of intravenous drug users. Vancouver Injection Drug Use Study Group. Int J Tuberc Lung Dis. 1999;3:153–155. 15. Hecox N. Tuberculin skin testing by pharmacists in a grocery store setting. J Am Pharm Assoc. 2008;48:86–91.
Journal of the American Pharmacists Association
Evaluation of a pharmacist-performed tuberculosis testing initiative in New Mexico Bernadette Jakeman, Brittni Gross, Diana Fortune, Sarrah Babb, Dale Tinker, and Amy Bachyrycz
Bernadette Jakeman, PharmD, PhC, AAHIVP, BCPS, Assistant Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM
Abstract Objective: To report experiences of the New Mexico pharmacist tuberculosis (TB) testing program.
Brittni Gross, Student Researcher, College of Pharmacy, University of New Mexico, Albuquerque, NM
Setting: Community pharmacies in New Mexico interested in participating in the TB testing initiative from March 2011 to August 2013.
Diana Fortune, BSN, TB Program Manager, New Mexico Department of Health, Santa Fe, NM
Practice innovation: To expand accessibility of TB testing, New Mexico pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011. To receive this special prescriptive authority, pharmacists had to complete a New Mexico Department of Health training program in accordance with the Centers for Disease Control and Prevention guidelines.
Sarrah Babb, BS, Student Researcher, College of Pharmacy, University of New Mexico, Albuquerque, NM
Evaluation: Data were collected on the number of TSTs performed and the TST reading follow-up rate. Patient data collected were demographic information, reason for obtaining a TST (e.g., immigration, school, or work), TB risk factors, and TST results. Results: In New Mexico, 43 pharmacists were certified for TB testing during the evaluation period, 25 of whom were actively prescribing and performing TB testing at eight community pharmacies. There were 606 tests administered to 578 patients; 70.9% women, median age 31 years (4–93 years). Employment and school were the main reasons for obtaining a TB test. A total of 578 of 623 (92.8%) patients followed up to have their TSTs read. A total of 18 positive tests (3.1% positivity rate) were identified and appropriate referrals were made.
Dale Tinker, BA, Executive Director, New Mexico Pharmacists Association, Albuquerque, NM Amy Bachyrycz, PharmD, Assistant Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM Correspondence: Bernadette Jakeman, PharmD, PhC, AAHIVP, BCPS, College of Pharmacy, University of New Mexico, 1 University of New Mexico, MSC 09 5360, Albuquerque, NM 87131; bjakeman@salud. umn.edu Previous presentation: American College of Clinical Pharmacy Annual Meeting, October 14, 2013, Albuquerque, NM Disclosure: The authors declare no relevant conflicts of interest or financial relationships. Received June 20, 2014. Accepted for publication October 10, 2014.
Conclusion: New Mexico expanded the scope of practice for pharmacists. Pharmacist-performed TB testing had a valuable public health benefit. TB testing follow-up rates at community pharmacies in New Mexico were high, most likely due to convenient hours, accessible locations, and no required appointments. J Am Pharm Assoc. 2015;55:307–312. doi: 10.1331/JAPhA.2015.14141
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ates of tuberculosis (TB) disease, caused by Mycobacterium tuberculosis, in the United States are decreasing.1,2 Despite this trend, TB remains one of the world’s leading causes of death.3 Therefore, treatment of TB infection is essential in controlling and eliminating the disease in the United States.2,4 Early identification of people who have been infected is key to preventing progression to active TB and transmission throughout the population.2,5 Published reports of pharmacist-performed TB testing are limited. To expand the accessibility of TB testing in New Mexico, pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011.
Objective The objective of this report is to describe experiences of the New Mexico pharmacist TB testing program. We describe the New Mexico Department of Health (DOH) TB testing certification and training, and report data on persons using pharmacist-performed TB testing services in community pharmacies.
Setting New Mexico DOH Clinics offered TB testing as a regular component of their health care services until state budget concerns affected their ability to provide the service in 2008 and 2009. The DOH limited testing to TB contacts, high-risk individuals (e.g., patients with human immunodeficiency virus [HIV] infections), and individuals with symptoms of active TB. New Mexico pharmacists were interested in providing testing services for individuals that needed testing for other reasons (e.g., school, work, immigrant status). However, a prescription for the service was necessary.
Key Points Background: ❚❚ ❚❚
Treatment of tuberculosis (TB) infection is essential in controlling and eliminating the disease in the United States. Published reports of pharmacist-performed TB testing are limited.
Findings: ❚❚ ❚❚ ❚❚
Between March 2011 and August 2013, 606 tests were successfully administered by pharmacists to 578 patients Testing follow-up rates were high at 92.8%, and the test positivity rate was 3.1% in this low-risk cohort. Expanding the scope of practice of pharmacists to include tuberculosis testing provides a valuable public health service.
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To expand the accessibility of TB testing, New Mexico pharmacists were granted the authority to prescribe, administer, and read tuberculin skin tests (TSTs) in March 2011 under regulation 16.19.26.12.6 The testing protocol is provided in Appendix 1, available on JAPhA. org in the Supplemental Content section. Chain and independent community pharmacies in New Mexico that were interested participating in the TB testing initiative were offered training and certification for their pharmacists. A total of 43 pharmacists were trained and certified for TB testing; 25 pharmacists actively prescribed and administered TSTs in community pharmacies during the study period. Data were collected from a total of eight different community pharmacies, including six chain pharmacies and two independent pharmacies, from March 2011 to August 2013. Tests were performed in both urban (Albuquerque, n = 163) and rural New Mexico (Roswell, n = 153; Carlsbad, n = 262).
Practice innovation The New Mexico Pharmacists Association worked with the New Mexico DOH to develop a protocol allowing pharmacists to prescribe and provide TB testing in New Mexico community pharmacies. The protocol received approval from the New Mexico Board of Pharmacy, New Mexico Medical Board, and New Mexico Board of Nursing, as required by statute. The new law did not require pharmacists to obtain this certification as part of their licensure. But pharmacists who were interested in obtaining certification to provide TB testing services were required to complete comprehensive training on how to prescribe, administer, read, and interpret the TST. Training, as outlined by the Centers for Disease Control and Prevention (CDC), was provided by registered nurses specializing in tuberculosis at the New Mexico DOH. The training consisted of a 1-hour self-study webinar, “Understanding the Tuberculin Skin Test: A Primer for non-TB Staff” supported by Heartland National TB Center, one of five regional training and medical consultation centers in the United States funded by the CDC and supported by a division of TB Elimination in conjunction with the New Mexico DOH and the New Mexico Pharmacists Association. The webinar is followed by a live 4-hour practicum that involved a handson training and skills demonstration. ACPE credit was available for the training. To rule out false-negative results, pharmacists who received the training were also instructed on how to identify patients who met the criteria for the two-step TST test. Some individuals infected with M. tuberculosis may have a negative reaction to the TST if many years have passed since they became infected.7 These individuals may have a positive reaction to a subsequent TST because the initial test stimulated their ability to react to Journal of the American Pharmacists Association
PHARMACIST TUBERCULOSIS TESTING PROGRAM EXPERIENCE
Figure 1. Patients requesting TSTs from pharmacists Abbreviation used: TST, tuberculin skin test.
the test. This is commonly referred to as the “booster” reaction and may incorrectly be interpreted as a skin test conversion. Booster rates have been reported as high as 14.2%.8 For this reason, the “two-step method” is recommended at the time of initial testing for individuals who may be tested periodically (e.g., health care workers).7
Evaluation This project was approved by the institutional review board at the University of New Mexico Health Sciences Center. Data were collected from participating community pharmacies in New Mexico that performed TB testing from March 2011 to August 2013. Data on pharmacist training were obtained from the New Mexico DOH training records. Pharmacist, pharmacy, and patient data were collected from the pharmacy testing consent forms completed at the time of testing in the community pharmacy. Each pharmacy developed its own TST consent forms based on the New Mexico DOH consent form, which is provided in Appendix 2, available on JAPhA.org in the Supplemental Content section. Minimal marketing was done during the data collection period and was left up to the individual participating pharmacies. Some Journal of the American Pharmacists Association
techniques that were used, based on area and need, included physician detailing, radio advertisements, wordof-mouth, in-store signage, electronic reader boards, and informational letters about the program to profit and nonprofit local universities. All patients who requested a TST in a community pharmacy during the evaluation period were included for assessment. Pharmacy data collected included the number of TSTs performed and the TST reading follow-up rate. Patient data collected included demographic information, reasons for obtaining the TST (e.g., immigration, school, or work), TB risk factors, and TST results. Patients of any age, who received a TST from a pharmacist in a New Mexico community pharmacy during the study period were evaluated. Patients with no follow-up or inappropriate follow-up, defined as a TST reading less than 48 hours or more than 72 hours after placement, were excluded from the analysis.
Results
Patient data Of 626 patients requesting TSTs at participating community pharmacies during the evaluation period, 3 did j apha.org
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Table 1. Characteristics of patients (n = 578) receiving pharmacistperformed tuberculin skin test in community pharmacies Characteristics Age, median (range) Gender Men and boys Women and girls Unknown Reason for obtaining test Employment School Immigration Other Unknown Patient medical history Past tuberculin skin test Positive Negative None Unknown Previous treatment of latent tuberculosis infection Yes No Unknown
No. (%) 31 (4–93) 146 (25.3) 410 (70.9) 22 (3.8) 156 (27.0) 91 (15.7) 2 (0.4) 33 (5.7) 296 (51.2)
13 (2.2) 122 (21.1) 179 (31.0) 264 (45.7) 1 (0.2) 249 (43.1) 328 (56.7)
Previous treatment of active tuberculosis Yes No Unknown
2 (0.4) 255 (44.1) 321 (55.5)
Past Bacillus of Calmette and Guerin vaccination Yes No Unknown
5 (0.9) 237 (41.0) 336 (58.1)
Current tuberculosis-like symptoms Yes No Unknown
5 (0.9) 499 (86.3) 74 (12.8)
Tuberculosis risk level High risk (n = 11) Organ transplant Recent contact with active case Immunosuppressed Moderate risk (n = 175) Immunocompromising medical condition Minor exposed to active case Injection drug use Correctional facility employee Health employee Mycobacteriology lab employee Recent travel in high-risk setting Other
1 (0.2) 2 (0.3) 8 (1.4) 29 (5.0) 3 (0.5) 1 (0.2) 4 (0.7) 115 (19.9) 1 (0.2) 9 (1.6) 6 (1.0)
not have the test performed, 45 were excluded, and 578 patients met the inclusion criteria during the evaluation period (2011, n = 131; 2012, n = 273; 2013, n = 174). In all, 45 patients were excluded because of no or inappropriate follow-up (Figure 1). 310 JAPhA | 5 5:3 | M AY /JUN 2 0 1 5
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Patient demographics are listed in Table 1. Results for some patient data could not be collected because of incomplete consent forms. These data are reported as unknown. Data on patients’ place of birth were not collected. Of the 578 patients included in the data analysis, 70.9% were women or girls, and the median patient age was 31 years (range, 4–93 years). Employment and school were the main reasons for obtaining a TST test. Patient TB risk level was determined by the presence of any of the qualifying factors from each category (Table 1). The majority of patients receiving TSTs in community pharmacies were low to moderate risk. Only 11 (1.9%) patients were identified as high-risk. Of the available data, there were no patients who were high risk due to HIV infection or a history of fibrotic changes on X-ray images. Test results A total of 606 TSTs were prescribed and administered by New Mexico community pharmacists to 578 patients. None of the 28 patients receiving a two-step TST had positive results. No adverse drug events were reported. A total of 18 of the 578 (3.1%) patients had a positive TST result. Of these 18 patients who had a positive TST, 7 were identified as low risk, 10 were identified as moderate risk, and 1 was identified high risk, making the TST positivity rate per risk group 1.7% (7/392), 5.7% (10/175), and 9.1% (1/11), respectively. Positive results were reported to the New Mexico DOH and to the patients’ primary care provider (PCP), if a PCP was identified by the patient. The New Mexico DOH was responsible for patient follow –up, and treatment for TB infection was given if indicated. Of the 18 patients with positive TSTs, none was determined to have active TB disease. None of the patients with a positive TST received treatment for latent infection during the study period. Of note, there was a nationwide shortage of the first-line antitubercular medication isoniazid (INH) during the study period. Because of this shortage, the New Mexico DOH reserved INH for treatment of patients with active TB disease or those patients who were considered high risk for progression to active TB disease, including recent contacts with active TB cases, HIV-positive patients, and patients receiving tumor necrosis factor alpha inhibitors. At the end of the study period there were no cases who had progressed to active TB disease. Follow-up Of the 623 patients who received a TST at a New Mexico community pharmacy, 578 (92.8%) had appropriate follow-up. These patients were included for additional analysis. Of the patients who were excluded from analysis, 3.2% had inappropriate follow-up time and 4% did not return to have their TSTs read. Journal of the American Pharmacists Association
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Discussion In 2011, New Mexico expanded the scope of practice for pharmacists to include prescribing, administering, reading, and interpreting TSTs. This regulation has been and continues to be successful, training a large number of pharmacists and reaching many patients in both urban and rural New Mexico. The number of pharmacists completing the training and administering tests has increased since 2013. Currently, 155 pharmacists have completed the certification training, with more training classes scheduled. Demand will also likely increase as patients become aware that pharmacists can provide this service. The scope of practice for pharmacists continues to expand and TB testing provides a great opportunity for pharmacists to have a positive effect on public health. Most pharmacists are willing to provide additional services in their communities as long as they receive proper education and training.9,10 While other options are available for TST services, the community pharmacy setting is ideal, with easy accessibility, extended hours, no required appointments, and pharmacist-provided education. This was evident in our report, with high follow-up rates of 92.8% seen at New Mexico community pharmacies. Follow-up rates range significantly between patient populations and countries.11–14 One of the disadvantages of the TST is the requirement to have the test read within 48 to 72 hours of placement due to the delayed-type hypersensitivity reaction. Patients often do not have the test read within the appropriate time. In a study by Serwint and colleagues, the TST reading return rate for 1,433 children at a pediatric clinic in Baltimore, MD, was 40%.12 In two additional studies that included injection drug users, TST follow-up rates were as low as 33% to 43%. However monetary incentives significantly improved return rates.13,14 The patients in our report who did not follow-up were not called by the pharmacies to determine the cause for inappropriate follow-up. It is unclear if this was to the result of other conflicts, poor patient education, or communication barriers. Even though follow-up was high, education regarding follow-up should be reinforced with all patients receiving TSTs. The price for the test was determined by participating pharmacies based on their individual costs. Patients were charged during initial test placement. Most insurance carriers do not cover TSTs, so patients were charged out-of-pocket costs for these tests. Community pharmacy prices for the TST (typically about $30) appeared to be lower than prices encountered at private clinics (e.g., travel clinics, ranging between $70 and $150). Most primary care providers in New Mexico do not provide the TST, because of their inability to bill insurance for the service. The New Mexico DOH offers TSTs at no cost to high-risk patients (e.g., HIV-positive patients). Despite Journal of the American Pharmacists Association
the out-of-pocket costs, patients in our study used this service at community pharmacies. Provision of TST services was successfully incorporated into the daily workflow in participating New Mexico community pharmacies. A TST pilot study in Washington state also found that implementing TB testing did not impede work flow.15 Workload issues are always a concern in community pharmacies, but many community pharmacies are exploring fee-for-service options to diversify revenue sources. The TST is a feasible service, requiring approximately 10 minutes to prescribe, administer, read, and interpret. During the evaluation period, pharmacists reported less than 1 additional prescription per day. Most pharmacist liability insurance policies cover activities that are within the scope of practice. Because TB testing was approved as part of the pharmacist’s scope in New Mexico, the practice was covered by the liability policies of participating pharmacists. No increase in insurance premiums was seen based on the expanded scope of activities related to TB testing. Other states, especially those with shortages of health professionals or other access issues in rural areas, should consider passing a similar law or implementing a standing physician order for TSTs, similar to what has been done for immunizations. Other issues to consider when implementing this program include: product considerations (e.g.., multi-dose vials expire 28 days after first use), training of sufficient number of pharmacists to ensure that trained pharmacists are available for followup TST readings, and company support to ensure that pharmacists have appropriate time and resources to provide this service. With pharmacists providing these public health services in the community, access is improved, which may allow us to identify infected patients earlier. The TST positivity rate observed in this cohort was 3.1%, even with the majority of patients meeting the low-risk criteria. Pharmacists were able to easily contact the New Mexico DOH TB program regarding positive cases to ensure appropriate follow-up care.
Limitations While this article offers important information regarding pharmacist-prescribed and -administered TSTs in a diverse population, our assessment is subject to several limitations. While demographic and characteristic data were collected, the forms were not completed for a large proportion of patients. Despite high follow-up rates, we were unable to determine additional barriers for patients who did not return for TST reading as scheduled. Marketing efforts were not evaluated. It is unclear if this would be required and what the potential costs would be. Despite these limitations, this is the first study evaluating pharmacist-prescribed and -performed TSTs. This study provides valuable information to other pharj apha.org
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macists who are interested in developing and providing this service in this or other states. The results give useful information on accessibility, TST positivity rates, and follow-up rates, and also demonstrate that there is a demand and a need for this service.
Conclusion New Mexico expanded the scope of practice for pharmacists. Pharmacist-performed TB testing had a valuable public health benefit. Follow-up rates at community pharmacies in New Mexico were high, most likely because of convenient hours, accessible locations, and no required appointments. This service could be especially beneficial in states with shortages of health professionals or other access issues in rural areas.
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6. Occupational and Professional Licensing: Pharmacists. Pharmacist Prescriptive Authority. http://nmcpr.state.nm.us/nmac/ parts/title16/16.019.0026.htm. Accessed June 18, 2014. 7. Centers for Disease Control and Prevention. Latent tuberculosis infection: a guide for primary health care providers. http://www. cdc.gov/tb/publications/ltbi/pdf/TargetedLTBI.pdf. Accessed June 18, 2014. 8. Kim SY, Park MS, Kim YS, et al. Tuberculin skin test and boosted reactions among newly employed healthcare workers: an observational study. PLoS One. 2013;8(5):e64563. doi: 10.1371/ journal.pone.0064563. 9. Eades CE, Ferguson JS, O’Carroll RE. Public health in community pharmacy: a systematic review of pharmacist and consumer views. BMC Public Health. 2011;11:582–595. 10. Oddis JA. Revisiting “the strengths of pharmacy”: the 1953 Remington Medal address. Am J Hosp Pharm. 1990;47:1985– 1988. 11. Macpherson P, Houben R, Glynn JR, et al. Pre-treatment loss to follow up in TB patients low and lower middle income countries and high burden countries: a systematic review and meta-analysis. Bull World Health Organ. 2014;92:126–138. 12. Serwint JR, Hall BS, Baldwin RM, et al. Outcomes of annual tuberculosis screening by Mantoux test in children considered to be at high risk: results from one urban clinic. Pediatrics. 1997;99:529–533. 13. Malotte CK, Rhodes F, Mais KE. Tuberculosis screening and compliance with return for skin test reading among active drug users. Am J Public Health. 1998;88:792–796. 14. FitzGerald JM, Patrick DM, Strathdee S, et al. Use of incentives to increase compliance for TB screening in a population of intravenous drug users. Vancouver Injection Drug Use Study Group. Int J Tuberc Lung Dis. 1999;3:153–155. 15. Hecox N. Tuberculin skin testing by pharmacists in a grocery store setting. J Am Pharm Assoc. 2008;48:86–91.
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