Community Pharmacy Can Help Solve National Health Equity Challenges Facing Clinical Research

Patients who are racial and ethnic minorities have been historically underrepresented in clinical trials, which has had lasting impacts on health equity and health 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,” said Tripp Logan, III, PharmD, vice president at SEMO Rx Pharmacies and SEMO Rx Care Coordination, in an interview with Pharmacy Times. “And pharmacy staff are from that community.”

According to the data, representation in clinical trials is not yet reflective of the diversity present in the country. 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%) compared to 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 used for clinical research either without their consent or without full information provided as to the purpose of the study.²

For example, in the 1932 US Public Health Service Syphilis Study at Tuskegee (Tuskegee), Black men were enrolled in a study to determine how untreated syphilis impacts the human body; however, the study participants were not informed they would be denied lifesaving treatment when it became available. With studies like Tuskegee still present in the minds of many Black patients, there continues to be a generational mistrust of clinical trials and a wariness toward physicians.²

Paradoxically, improving diversity in clinical trial recruitment could also help to garner greater trust in the health care system, explained Jacinda Abdul-Mutakabbir, PharmD, MPH, AAHIVP, assistant professor of clinical pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, in an interview with Pharmacy Times.² Further, inclusion in clinical trials would serve to improve the health outcomes of minority patients and support more widespread benefit from innovative therapies for more patients.¹

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.During this pilot project, investigators asked pharmacists at 5 geographically diverse community pharmacies to collect data on race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, Other, or White) and ethnicity (Hispanic or Latino versus Not Hispanic or Latino). Patients provided this 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%) patients documented both race and ethnicity. After the 8-week intervention, 3852 patients (6.79%) filled out a form and documented race, while 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.

Additionally, some pharmacies experienced slow momentum in patient engagement, such as in one smalltown Louisiana pharmacy. However, a rural Texas pharmacy addressed this same problem by catering to the majority Spanish-speaking population of the area, allowing patients to provide their race and ethnicity data in forms written in Spanish. In addition, another pharmacy based in Miami 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 actual US Census Data. This worked to confirm that the racial and ethnic makeup of the populations who shop at these community pharmacies reflect the diverse makeup of people who live in the surrounding area. However there were challenges in collecting these data, whether it was staffing/time constraints or awkward conversations with patients.

“Patients with complex conditions, particularly those that are socially vulnerable, are [also] extremely challenging to engage and keep engaged with the broader health care system,” Logan said.

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 be wise to have different procedures for collecting patient intake/data as well.¹

Standardizing the terminologies and qualifications for race, ethnicity, and other social determinants of health (SDOH) could also advance health equity, said Jake Galdo, the managing network facilitator at CPESN Health Equity and co-founder and CEO of Seguridad, Inc in Birmingham, Alabama, in an interview with Pharmacy Times.

Data standards— which include the “methods, protocols, terminologies, and specifications for the collection, exchange, storage, and retrieval of information associated with health care applications,” according to the authors of Patient Safety: Achieving a New Standard for Care³— can make health equity-related information (ie, race and ethnicity) translatable across health care industries and sectors, according to Galdo.

“[It can become] a Rosetta Stone for health equity work,” Galdo explains.

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

“It's a win for patients with increased access to specialized care that may not have been available previously and it's a win for clinical trial sponsors to have trials that represent the diversity of the United States,” Galdo said.

Further, standardized SDOH documentation could improve the chance that a pharmacist receives reimbursement from the Centers for Medicare and 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 explains.

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 noted that 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. ESPhA. Article. 2023. Accessed September 5, 2023.
2. Hippensteele, A. Community Pharmacies Can Improve Clinical Trial Recruitment for Racial, Ethnic Minority Patients. News Release. Pharmacy Times. August 9, 2023. Accessed on September 5, 2023. https://www.pharmacytimes.com/view/community-pharmacies-can-improve-clinical-trial-recruitment-for-racial-ethnic-minority-patients
3. Institute of Medicine (US) Committee on Data Standards for Patient Safety. Patient Safety: Achieving a New Standard for Care. 2004. National Academies Press. https://www.ncbi.nlm.nih.gov/books/NBK216088/