Raven Jackson, PharmD

The role of the pharmacist has expanded significantly from the traditional concept of medication dispensing. Today, pharmacists provide more direct patient care through services rendered directly to the patient at the pharmacy. One such service is the provision of health testing via point of care testing (POCT). Another is the management of patients with complex disease states that require high-cost cutting edge specialty medications.

  This article will discuss pharmacists’ impact in the areas of both POCT and specialty pharmacy, as well as highlight how these areas support the efforts of obtaining provider status for pharmacists. 

The Clinical Laboratory Improvement Amendment (CLIA) of 1988 was created more than 30 years ago. However, there has been a recently renewed interest in CLIA-waived POCT in pharmacy due to advances in the testing technology and an increased need for accessible testing. The nation is currently facing a shortage of primary care doctors, and as a result, pharmacists are being viewed as viable candidates to offer health screenings for potentially serious but not yet diagnosed conditions.

 The NCPA states that CLIA-waived POCT includes, but is not limited to, testing for acute and chronic conditions such as influenza, group A strep, HIV, hepatitis C, dyslipidemia, and diabetes.


	While these common tests are extremely valuable, pharmacists must remain responsive to the changing needs of patients as new situations and challenges develop in 2018. A 2017 article demonstrated the impact of pharmacists in Flint, MI, conducting POCT testing for lead levels during the public health response to the contamination of the city’s water supply. Pharmacists used CLIA-waived POCT to provide free blood lead testing during a six-month interval to the community. They also provided education to patients about the test results and then forwarded results to local and state agencies. Michael Klepser, PharmD, an associate professor at the University of Nebraska College of Pharmacy, noted that many communities in the United States are at risk for public health threats similar to what happened in Flint.

 To ensure our future preparedness, pharmacists will need to continue finding ways to use POCT to assist patients who face emerging public health threats.  

There is also a need for pharmacists to conduct POCT to screen for hepatitis C virus (HCV), which is on the rise largely due to the opioid crisis. According to the CDC, there has been a 400% increase in acute HCV infection from 2004 to 2014 among people aged 18 to 29 and a 325% increase among those aged 30 to 39,

  which highlights the need for accessible testing. This is especially true given the communicable nature of hepatitis C and the fact that about half of adults with HCV do not know they have it.


	A study published in Clinical Infectious Diseases has suggested that a one-time screening for all adults 18 and older could be a cost-effective way to identify HCV positive patients, increase cure rates from 40% to 61%, and reduce morbidity and mortality.

 Implementing this type of recommendation would significantly increase the need for HCV testing. Studies have already confirmed that community pharmacies are a viable location to test for hepatitis C. During a pilot project, pharmacists successfully incorporated POCT for HCV into their daily work, counseled patients on transmission and prevention, and provided links to care.


	Overall, the use of POCT to address both traditional and emerging health problems is an important avenue for pharmacists to provide direct patient care now and in the future.

Specialty pharmacies focus primarily on providing medication and drug therapy management for patients with specific disease states, or who require drugs needing special handling or with a high price. Disease states such as cancer, HIV/AIDS, hepatitis, immune disorders, infertility, and others are managed by a team of healthcare providers to ensure optimum treatment for each patient. A report from IMS Institute for  Healthcare Informatics projects that, in 2020, 28% of global spending will be for specialty medications, up from 26% in 2015.

Pharmacists have prepared for specialty roles primarily through residency or certificate training programs. In the 2012 APhA Career Pathway Evaluation Program survey, 30% of 27 specialty pharmacist respondents indicated they had completed a residency and 30% said they completed a certificate training program before becoming a specialty pharmacist.

Pharmacists can also obtain certification in 12 specialties through the Board of Pharmacy Specialties (BPS). There are currently more than 36,000 pharmacists certified through BPS nationally and internationally. BPS plans to continue to monitor the growth in solid organ transplant and emergency medicine in order to recognize them as distinct specialties by 2020.

 While completing a residency is beneficial, there are other avenues and certificates available for pharmacists. The Specialty Pharmacy Certification Board (SPCB) allows pharmacists who haven’t completed residency training to remain up to date in clinical practices and become certified to work in this area. According to SPCB, the certificate can be obtained after 3,000 hours of pharmacy practice within the last four years as well as the completion of specialty pharmacy continuing education.

Current advances in pharmacy training and continued growth in the prevalence of rare diseases will undoubtedly result in an increase in the number of specialty pharmacies providing high-touch high-cost medications. As these numbers increase, there will be a larger need for pharmacists who are fully trained in this growing area of pharmacy practice.

Several key pharmacy organizations are working together to achieve provider status for pharmacists through many routes. Pharmacists are providing high level patient care such as medication therapy management (MTM), disease state education, health screenings, and wellness services such as immunizations. According to APhA, attaining provider status will increase patient access to specialty pharmacies and POCT, which will create an incentive for  pharmacists to provide even more high-level care services.

  Passage of the bill would also enable pharmacists to be reimbursed for services under Medicare Part B and is expected to allow for  immediate billing for services like MTM.

 With POCT and specialty pharmacy allowing pharmacists to provide clinical expertise in such an innovative manner, the vision of provider status in the future is only becoming more clear.

1. American Pharmacists Association (APhA). Specialty Pharmacy. Accessed April 5, 2018, at https://www.pharmacist.com/specialty-pharmacy

2. Klepser DG, Klepser ME. Point of Care testing in the pharmacy: how is the field evolving? Accessed April 1, 2018, at https://www.tandfonline.com/doi/pdf/10.1080/14737159.2018.1392240

3. National Community Pharmacists Association. Point-of-Care (POCT) Testing. Accessed April 1, 2018, at https://www.ncpanet.org/innovation-center/diversified-revenue-opportunities/point-of-care-(poc)-testing

4. Balick, R. Pharmacists Step up to help in Flint, MI. 2017 March. Accessed April 1, 2018, at http://www.pharmacytoday.org/article/S1042-0991(17)30241-4/fulltext

5. Center for Disease Control and Prevention. Hepatitis C and opioid injection rose dramatically in younger americans From 2004-2014.. Accessed April, 2 2018, at https://www.cdc.gov/nchhstp/newsroom/images/2017/HepC-opioid-injection-lineGraph-young-americans_highres.jpg

6.Kugelmas, M. et al. Hepatitis C Point-of-Care Screening in Retail Pharmacies in the United States. 13 February 2017 Gastro Hepat.  Accessed April 2, 2018, at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402690/

7. Toich, L. Study: Testing all adults for hepatitis c virus is cost effective. Spec Pharm Times. Accessed April 2, 2018 at https://www.specialtypharmacytimes.com/news/study-testing-all-adults-for-hepatitis-c-virus-is-cost-effective

8. Dong, BJ et al. Pharmacists performing  hepatitis C antibody point-of-care screening in a community pharmacy: A pilot project. Accessed April 10, 2018, at https://www.ncbi.nlm.nih.gov/pubmed/28602784

9. Aitken, M, Kleinrock, M. Global spending on medicines in 2020: outlook and implications. IMS Institute for Healthcare Informatics. November 2015. Accessed April 24, 2018 at https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/global-medicines-use-in-2020.pdf?la=uk-ua&hash=968B71C0B0769A179F3A56E331C62754EEF74752

10. Pharmacist.com. Specialty Pharmacy. Accessed April 6, 2018 at
	https://www.pharmacist.com/sites/default/files/files/Profile_28 Specialty Pharmacy Final 071213.pdf

11. Board of Pharmacy Specialties. History.Accessed April 09, 2018 at https://www.bpsweb.org/about-bps/history/

12. Specialty Pharmacy Certification Board. Eligibility Requirements. Accessed April 09, 2018 at
	http://www.spcboard.org/certification/eligibility-requirements/

13. American Pharmacists Association. Provider Status: What pharmacists need to know. (n.d.). APhA Accessed April 3, 2018 at https://www.pharmacist.com/provider-status-what-pharmacists-need-know-now

14. Provider Status Update. Pharmacy Times. 24 March 2016 Pharmacy Times Accessed April 6, 2018 at http://www.pharmacytimes.com/publications/health-system-edition/2016/march2016/provider-status-update

Alison Neuliep, Trisha Obinyan are students at the College of Pharmacy at Xavier University of Louisiana. Raven Jackson, PharmD, is clinical assistant professor of pharmacy at Xavier.

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