Pharmacy Colorectal Cancer Screening Protocol Shows Potential of Pharmacists in Preventative Health

Colorectal cancer (CRC) screening does not have to be an invasive colonoscopy procedure. In Kentucky, it may be as simple as stopping into your local pharmacy.

In September 2021, the Kentucky Board of Pharmacy approved the sixteenth board-authorized protocol allowing Kentucky pharmacists—under the authorization of a prescriber—to screen, educate, and order noninvasive stool-based CRC screening tests using fecal immunochemical test (FIT) or stool DNA tests (sDNA-FIT).¹

Patients who wish to see a pharmacist for CRC screening must meet the criteria outlined in the protocol. Most patients aged 45-85 years with an average risk for CRC who are due for screening are eligible for pharmacist-led screening. If a stool-based screening test is ordered for a patient, they must be able and willing to undergo a screening completion colonoscopy if positive results are obtained.

Kentucky pharmacists can provide unique services, such as colorectal cancer screenings, through Kentucky Board of Pharmacy authorized protocols. This process is outlined in state regulation 201 KAR 2:380.²

The statutory authority comes from KRS 315.010(25), 315.191(1)(a),(f). The current list of board-authorized protocols in Kentucky, including the colorectal cancer screening protocol, can be found on the board’s website at pharmacy.ky.gov/Pages/Board-Approved-Protocols.aspx. The protocol outlines the responsibilities of the pharmacist to educate and follow-up with the patient and provides specific notification procedures for the patient, their primary care provider if applicable, or the authorizing provider who signed the pharmacy protocol.

Colorectal cancer is the fourth most common form of the disease and the third leading cause of cancer death in the United States.^3,4 While having a family history of CRC puts you at a higher risk of CRC, approximately 75% of patients diagnosed with CRC have no family history.⁵

CRC typically starts as a polyp on the wall of the colon or rectum and, if undetected, may develop into cancer. When CRC is detected early in the localized stage, patients have a 90.9% 5-year relative survival rate; however, when detected late in the distant stage, the 5-year rate of relative survival drops to 15.1%.³

Screening is vital for early detection and survival rates of CRC, as symptoms of CRC may not develop until later stages of cancer. The rate of new CRC cases in the United States from 2015-2019 was 37.7 cases per 100,000, whereas Kentucky’s incidence rate during this period was 47.4 cases per 100,000.⁶

The most recent data from 2020 show that 75.4% of Kentuckians aged 50-75 years have had a reported CRC screening compared to the national average of 74.5%.⁷ Since 2012, Kentucky has trended up right alongside the national average for CRC screenings; however, the recent COVID-19 pandemic has negatively impacted CRC screenings.

In a model-based estimation of CRC screening during COVID-19, the expansion of FIT-based CRC screening was studied. Their estimations suggested that up to 43% of eligible patients could remain unscreened without increased use of FIT-based screening to offset decreased colonoscopy screenings.⁸

This would result in approximately 13,000 fewer CRC diagnoses and 9000 fewer early-stage CRC diagnoses. Many factors are likely to blame for the persistent decline in screenings, including back logged procedures, health system reduction in services due to staffing shortages, loss of employment-associated health insurance, and prolonged patient fear of health care associated exposure to COVID-19.

Kentucky pharmacists have proven their ability to fill the gaps and increased needs in providing health care caused by the COVID-19 pandemic. The opportunity to provide non-invasive CRC screening and education to patients is undoubtedly a role the pharmacist can fill.

Any Kentucky pharmacy may offer this service upon having an authorizing provider sign the board-authorized protocol and the pharmacist(s) providing the screening completes an accredited educational training for pharmacists on CRC screening. If a patient qualifies for a stool-based CRC screening test and a mutual decision is made between the pharmacist and patient to use this screening method, the stool-based test is billed to the patient’s medical insurance.

These tests are covered by 95% of insurance. However, avenues for reimbursement of pharmacists’ time spent providing clinical services are limited, inhibiting the sustainability of pharmacists incorporating CRC screenings into their daily workflow and routinely offering this service.

The Kentucky Association of Health Plans (KAHP), the trade association representing all commercial insurers and Medicaid managed care plans in Kentucky, awarded the Kentucky Pharmacists Education and Research Foundation (KPERF) a $50,000 grant to expand access to these screenings throughout the state. The grant is designed to expand the number of pharmacies and pharmacists who can provide this service to Kentuckians.

Through the grant funding, 6 participating pharmacies will be reimbursed for providing pharmacist-led screening and follow-up. The 6 pharmacies chosen to participate will be spread across the state, prioritizing areas in which CRC screening rates are low. KPERF, in managing the grant, will collect data on the outcomes of pharmacies providing CRC screenings.

As the most accessible health care provider, pharmacists are trusted and uniquely positioned to help patients achieve better outcomes. Colorectal cancer screenings and pharmacist-led protocols, in general, equip pharmacists with another opportunity to improve the lives of their patients.

As the number of pharmacies offering CRC screenings continues to grow, we hope to continue to prove the difference pharmacists make in preventative health, allowing this to be a replicable service across the state and the nation.

About the Author

Emily Wilkerson, PharmD, a 2022 graduate of the University of Kentucky College of Pharmacy, is the Executive Fellow at the Kentucky Pharmacists Association in Frankfort, KY.

References

1. Colorectal Cancer (CRC) Screening Protocol Approved 9/18/2021

2. Kentucky General Assembly Title 201 Chapter 2 Regulation 380 • Kentucky Administrative Regulations • Legislative Research Commission. Available at https://apps.legislature.ky.gov/law/kar/titles/201/002/380/. Accessed January 5, 2023.

3. Cancer of the colon and rectum - cancer stat facts (no date) SEER. Available at https://seer.cancer.gov/statfacts/html/colorect.html. Accessed January 5, 2023.

4. Colorectal cancer prevention (PDQ®)–patient version (no date) National Cancer Institute. Available at https://www.cancer.gov/types/colorectal/patient/colorectal-prevention-pdq Accessed January 5, 2023.

5. Genetics of Colorectal Cancer (PDQ®)–health professional version (no date) National Cancer Institute. Available at https://www.cancer.gov/types/colorectal/hp/colorectal-genetics-pdq. Accessed January 5, 2023.

6. State Cancer Profiles > Quick Profiles. Available at https://statecancerprofiles.cancer.gov/quick-profiles/index.php?statename=kentucky Accessed January 5, 2023.

7. Colorectal Cancer Screening (no date) America's Health Rankings. Available at https://www.americashealthrankings.org/explore/annual/measure/colorectal_cancer_screening/state/KY. Accessed January 5, 2023.

8. Issaka RB, Taylor P, Baxi A, Inadomi JM, Ramsey SD, Roth J. Model-Based Estimation of Colorectal Cancer Screening and Outcomes During the COVID-19 Pandemic. JAMA Netw Open. 2021;4(4):e216454. doi:10.1001/jamanetworkopen.2021.6454