Community Pharmacy Can Help Solve Health Equity Challenges in Clinical Research

Racial and ethnic minority patients have been historically underrepresented in clinical trials, leaving lasting impacts on health equity and outcomes.¹ New data from the Pilot Project on Collection of Patient Race and Ethnicity Data suggest that community pharmacies could have a major role in identifying diverse patient populations for clinical trial enrollment. Further, community pharmacists can play a role in trial recruitment by leveraging relationships with patients to support greater trust in clinical research.¹

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“You don’t get more local than community pharmacies, and pharmacy staff are from that community,” Tripp Logan III, PharmD, vice president of SEMO Rx Pharmacies and SEMO Rx Care Coordination, said in an interview with Pharmacy Times.

According to the data, representation in clinical trials is not yet reflective of the overall diversity in the US. According to the FDA 2020 Drug Trials Snapshots Summary Report, more than 12.5 times the number of participants in clinical trials were White (75%) than Asian (6%). Additionally, only 8% of patients in clinical trials were Black and 11% were Hispanic.¹

One factor that may contribute to a lack of diversity among clinical trial participants is a generational mistrust in clinical research, particularly among the Black community. In the United States, there is a lengthy history of Black patients being involved in clinical research either without their consent or without full information provided as to the purpose of the study.²

The 8-week Pilot Project on Collection of Patient Race and Ethnicity Data was conducted to understand the feasibility of documenting health-related patient race and ethnicity information at the community pharmacy. Investigators asked pharmacists at 5 geographically diverse community pharmacies to collect data on race and ethnicity. Patients provided these data by filling out a patient intake form at the pharmacy.¹

According to the investigators, the study results showed that it is feasible for community pharmacists to collect race and ethnicity data, as the study resulted in the investigators gathering 56,723 patient responses. At baseline, 2259 patients (4.22%) filled out the form to document race and 1093 (2.04%) documented both race and ethnicity. After the 8-week intervention, 3852 patients (6.79%) filled out a form and documented race whereas 2504 patients (4.41%) documented both race and ethnicity.¹

Notably, documentation increased by more than 2500% at one of the community pharmacies located in Ohio. At another pharmacy in Mississippi, pharmacists incentivized patients to document data with a prize drawing, using a text-based digital collection process to facilitate data collection.¹

Some pharmacies experienced slow momentum in patient engagement, such as in one small-town Louisiana pharmacy. However, a rural Texas pharmacy addressed this problem by catering to the majority Spanish-speaking population in the area, allowing patients to provide their race and ethnicity data in forms written in Spanish. In addition, another pharmacy based in Miami, Florida observed similar results and successfully got patients to document race and ethnicity.¹

Investigators then compared the race and ethnicity data collected at the pharmacy with US Census data. This confirmed that the racial and ethnic makeup of the populations who visit these community pharmacies reflects the diverse makeup of people who live in the surrounding areas. However, there were challenges in collecting these data, including staffing, time constraints, and awkward conversations with patients.¹

To remediate these issues, most pharmacists agree that point-of-sale support would make it easier to document health-related patient race and ethnicity information. It could help to have different procedures for collecting patient intake forms and data as well.¹

Standardizing the terminologies and qualifications for race, ethnicity, and other social determinants of health (SDOH) could also advance health equity, Jake Galdo, PharmD, MBA, the managing network facilitator at CPESN Health Equity and cofounder and CEO of Seguridad, Inc, in Birmingham, Alabama, said in an interview with Pharmacy Times. Data standards can make health equity–related information (ie, race and ethnicity) translatable across health care industries and sectors, according to Galdo.

A health equity data standard would also allow researchers who conduct clinical trials to quickly identify and connect diverse patients to resources based on SDOH.

Further, standardized SDOH documentation could improve the chance that a pharmacist receives reimbursement from the Centers for Medicare & Medicaid Services through one of its value-based programs. Without standardized data, there is no proof of the value of the pharmacist in addressing health inequities—even if the pharmacist is addressing them, Galdo said.

Community pharmacies can even address SDOH and improve health equity outcomes by coordinating care for vulnerable patients and community members, Logan said. To this end, a growing number of community pharmacies have added SDOH specialists and community health workers to their staff to facilitate these efforts.

Regarding next steps following the pilot project findings, Logan said the focus will be on education and scaling results.

“[We need to] educate decision makers on the value that can be realized by utilizing community pharmacy relationships to solve very personal, local, complex problems, many of which are socially driven and not clinical,” Logan said. “[Additionally, we need to] scale these efforts quickly to help as many patients locally as possible.”

References

1. Community pharmacy demographic trends: a pilot project on collection of patient race and ethnicity data. Enhanced Service Pharmacy Alliance. 2023. Accessed September 5, 2023.

2. Hippensteele A. Community pharmacies can improve clinical trial recruitment for racial, ethnic minority patients. Pharmacy Times. August 9, 2023. Accessed September 5, 2023. https://www.pharmacytimes.com/view/community-pharmacies-can-improve-clinical-trial-recruitment-forracial-ethnic-minority-patients