Abstract
The United States pays more for medical care than any other nation in the world, including for prescription drugs. These costs are inequitably distributed, as individuals from underrepresented racial and ethnic groups in the United States experience the highest costs of care and unequal access to high-quality, evidence-based medication therapy. Pharmacoequity refers to equity in access to pharmacotherapies or ensuring that all patients, regardless of race and ethnicity, socioeconomic status, or availability of resources, have access to the highest quality of pharmacotherapy required to manage their health conditions. Herein the authors describe the urgent need to prioritize pharmacoequity. This goal will require a bold and innovative examination of social policy, research infrastructure, patient and prescriber characteristics, as well as health policy determinants of inequitable medication access. In this article, the authors describe these determinants, identify drivers of ongoing inequities in prescription drug access, and provide a framework for the path toward achieving pharmacoequity.
The United States spends more on medical care than any other country. This includes more than $370 billion spent annually on prescription drugs (Martin et al. 2021). While much of these costs are not directly faced by individuals, Americans spend more than $1,100 per capita each year on out-of-pocket health care expenditures, including prescription drugs (Schumock et al. 2019; Vangipuram Suresh et al. 2021). Nevertheless, because there is an unequal burden of disease, health care spending is not evenly distributed across racial and ethnic groups, resulting in profound inequities in health care utilization and in access to high-quality, evidence-based medication therapy (Essien, Dusetzina, and Gellad 2021).
Pharmacoequity refers to equity in access to pharmacotherapies, or ensuring that all patients, regardless of race, ethnicity, socioeconomic status, or availability of resources have access to the highest quality of pharmacotherapy required to manage their health conditions. Earlier work has demonstrated that individuals from racial and ethnic (hereafter referred to as racial) minority groups are less likely to be prescribed both novel treatments and commonly used, generic therapies (Essien et al. 2018). They are also less likely to receive guideline-directed or emergency-use treatments and preventive or acute care therapies (Rodriguez et al. 2021). These treatment disparities persist despite the significant economic costs associated with downstream health inequities among racial minority populations (LaVeist, Gaskin, and Richard 2011).
Achieving pharmacoequity must be a public health and policy priority to reduce health disparities. Achieving this goal will require a bold and innovative examination of social policy, research, patient, prescriber, and health policy determinants of inequitable medication access (figure 1). In this article, we will describe each of these aforementioned determinants, identify drivers of ongoing inequities in pharmacotherapy access, and provide a framework for the path toward achieving pharmacoequity.
Social Policy and Pharmacoequity
Racial disparities in pharmacotherapy access have been shaped by discriminatory social policy in the United States that continues to have broad consequences for racial minority populations (Hardeman, Hardeman-Jones, and Medina 2021; Williams and Mohammed 2013). Racial disparities are steeped in the legacy of slavery and perpetuation of structural racism, a system in which public policies, institutional practices, cultural representations, and other norms work to perpetuate racial group inequity (Jones 2000). American history is marked by inequitable investment in, and intentional dismantling of, racial minority communities, resulting in unequal health care, and therefore unequal pharmaceutical access (Kendi 2016; Smith 2021).
Public Transportation and Infrastructure
Broad swaths of America's transportation infrastructure were originally designed to divide, degrade, and disadvantage racial minority communities. For example, government engineers in the 1950s and 1960s intentionally built highways through Black neighborhoods while steering clear of primarily white ones, scarring their landscapes and segregating them from surrounding communities. Compounded by white flight to suburban settings, these highways drained wealth from urban neighborhoods, catalyzing racial inequities in investment and development (McGhee 2021). To pay for this massive expansion of car-based infrastructure—and to further appease new suburban car owners and commuters traveling on highways—governments gutted funding for urban public transportation systems.
Today, relative to white Americans, a greater proportion of Black and Latinx Americans lack a car (Raphael et al. 2001) and rely on public transportation (Anderson 2016). This disparity is amplified by the fact that only 20% of federal transportation expenditures are allocated to public transportation, and a disproportionately low share of those funds are spent on bus service, the mode of transit most used by racial minority riders. This underfunding is typically passed down to riders as fare increases or service cuts that create barriers to those dependent on public transit. Patients facing transportation barriers are less likely to fill their prescriptions and more likely not to take them as prescribed (Hensley et al. 2018; Syed, Gerber, and Sharp 2013). Furthermore, the transportation barriers outlined above limit timely access to pharmacies and prescribers (Wolfe, McDonald, and Holmes 2020).
Geographic Access to Pharmacies
Barriers to pharmacotherapy access are exacerbated by the unequal distribution of pharmacies in the United States, one of many reflections of systematic disinvestment in minority communities driven by racist policies, such as restrictive covenants, redlining, denial of federally insured mortgages, and predatory mortgage lending that persisted into the 20th and 21st centuries (Rothstein 2017; Wilkerson 2010).
Pharmacy deserts—neighborhoods with low geographic accessibility to pharmacies—are disproportionately found in Black and Latinx neighborhoods nationwide, impacting medication access for nearly 15 million people (Guadamuz et al. 2021). Furthermore, racial minority neighborhoods face higher rates of pharmacy closure, which has been associated with poor medication adherence (Qato et al. 2019). Earlier work has even suggested that pharmacies in lower-income neighborhoods have higher drug prices than those in wealthier neighborhoods, further disadvantaging these populations (Gellad et al. 2009).
Moreover, chain pharmacies—typically facilities with larger medication stocks, longer operating hours, and more extensive services—are less dense in low-income communities, which are instead primarily served by independent pharmacies. These smaller pharmacies are more likely to have common medications go out of stock and more likely to close (Amstislavski et al. 2012). The opening of new pharmacies further contributes to racial inequities, as they are less likely to be placed in racial minority neighborhoods (Guadamuz et al. 2021).
Income and Wealth Inequities
The foundational social policies discussed above have also shaped financial barriers to pharmacotherapy access by promoting inequities in opportunity, employment, income, and generational wealth (Rothstein 2017). Perhaps most saliently, the median wealth of white households dwarfs that of Black and Latinx households, a gap that continues to widen in recent decades. For instance, in 1998 the median wealth of Black households was 18.8% of the median wealth of white households, compared to 9.5% in 2016 (Hanks, Solomon, and Weller 2018; Weller and Roberts 2021). This wealth gap worsens access to the often-expensive therapies needed to lead a healthy life. Compared to white households, Black and Latinx households report having 1.4 and 3.7 times higher rates, respectively, of forgoing prescription medications to reduce costs (Bakk 2015b). These financial barriers underscore the importance of drug pricing policy in ensuring access to pharmacotherapies, whether through promotion of generic and biosimilar entry via patent policy reform (Grabowski, DiMasi, and Long 2015) and legislation preserving competition in markets or through more aggressive, direct regulation such as Medicare Part D price negotiation and international reference pricing (Ferrario et al. 2020).
An examination of income and wealth inequalities and other social determinants that shape unequal pharmacotherapy access reinforces that medication disparities are inextricable from broader racial inequities in the United States. For example, the criminal justice system, which disproportionately incarcerates Black and Latinx individuals, also provides suboptimal access to essential medications in prisons (Nunn et al. 2009). The racist social policies of the 20th and 21st centuries have led to longstanding disinvestment in racial minority communities and their health outcomes. The disparities in pharmacotherapy access that such disinvestment contributes to are merely symptomatic of this larger social ill.
Research Representation and Pharmacoequity
Inequities in the drug development pipeline may propagate disparities in pharmacotherapy access beyond drugs already on the market (Fisher 2020). Implicit in the very idea of “access” is ensuring access to therapies that are supported by evidence. Nevertheless, in the United States, Black and Latinx patients have been historically underrepresented in phase 3 clinical trials (Chastain et al. 2020; Duma et al. 2018; Zhang et al. 2013) because of limited geographic availability, cost, racial bias, and a legacy of exploitative medical experimentation (Hamel et al. 2016). Furthermore, these disparities in racial representation have persisted despite recognition and guidance from the Food and Drug Administration (FDA 2016) and a legislative mandate for representation of racial minority groups in clinical research funded by the National Institutes of Health (NIH) (Freedman et al. 1995). These regulatory measures have fallen short in part because of the FDA and NIH having limited mechanisms to enforce their guidance, particularly given the prevalence of industry-sponsored trials that often fall beyond the purview of federal sponsors (Loree et al. 2019). One approach to address this regulatory gap could include the Centers for Medicare and Medicaid Services using the coverage determination process to require that covered drugs be studied in clinical trial populations that reflect the beneficiary populations (CMS 2021).
Moreover, racial minority populations may be overrepresented in phase 1 safety studies that require the participation of healthy participants, who therefore bear greater risks without known therapeutic benefits, further highlighting inequities in the drug development pipeline (Fisher and Kalbaugh 2011). Recent federal policy to support routine clinical trial costs for Medicaid enrollees may be a useful strategy to address unequal trial representation (Takvorian, Guerra, and Schpero 2021). Additionally, increased governmental investment in community-based pharmacotherapy research will be key to improving pharmacoequity. Finally, with the rise of precision medicine, there are important opportunities to study the relationship between genetic ancestry, epigenetics, and biological traits when developing novel therapies (Amutah et al. 2021).
Prescribers, Patients, and Pharmacoequity
Prescriber-Level Determinants
Whereas the structures and systems described above represent critical drivers of unequal pharmacotherapy access, prescribers—including physicians, advanced practice providers, nurses, and pharmacists—maintain an outsized role in drug prescribing. A large body of research describes differential medication prescribing by race and ethnicity, including cardiovascular drugs (Lauffenburger et al. 2014), medications for substance use disorder (Essien et al. 2020), and pain medications. For example, one study found that Black children are less likely than clinically similar white children to receive pain medication for appendicitis (Goyal et al. 2015). Furthermore, the quality of prescribing is unequal, as Black patients have been shown to be more likely to receive older therapeutics and inappropriate dosing compared to white patients (Essien et al. 2018). Earlier studies have sought to examine whether implicit bias plays a role in these treatment disparities and have observed that simply changing the race of a patient with the same clinical presentation results in differential management (Breathett et al. 2020; Schulman et al. 1999). Along with structural factors, such as higher medical and social complexity of patient panels and lower reimbursement rates in underresourced care settings (Delaney, Essien, and Navathe 2021), the mechanisms by which unequal prescribing may occur include inadequate time spent with patients, falsely held beliefs about biological differences between racial groups, and limited prescriber-patient racial concordance (Alsan et al. 2021; Cooper et al. 2003; Hoffman et al. 2016). The prevalent inequity in treatment suggests an urgent need to study and implement novel interventions, including implicit bias training, disparities dashboards for clinicians to assess their practice (Burkitt et al. 2021), and electronic medical record alerts to ensure that medications are prescribed equitably for all patients.
Patient-Level Determinants
While broad society- and prescriber-level determinants drive pharmacoequity, patient-level factors, such as trust and language barriers, also play a central role in increasing pharmacotherapy access. These elements are especially important to consider when seeking to prioritize patient-centered care and shared decision making.
Health Care Trust
Patient trust in the health care system is paramount to the delivery of patient-centered care (Sakallaris et al. 2016) and is associated with improved health outcomes (Birkhäuer et al. 2017). Nevertheless, a long history of racism in medicine and research, including the US Public Health Service Syphilis Study at Tuskegee, Alabama (Alsan, Wanamaker, and Hardeman 2020), has contributed to distrust in the health care system among many within racial minority communities (Washington 2006).
A higher level of health care system distrust has resulted in the underutilization of health care resources, including preventive health services among Black Americans (Musa et al. 2009). In addition, Black Americans are more likely to perceive racism in the medical care system, leading to less satisfaction with care. Perceived discrimination in the health care system is correlated with delayed filling of prescribed treatments (Van Houtven et al. 2005). Furthermore, medical distrust appears to be one source of lower participation in COVID-19 vaccine trials by Black Americans (Thompson et al. 2021).
When examining patient distrust in health care, it is important to note that the onus does not fall on racial minority populations. This distrust is a warranted response to a history of exploitation, mistreatment, and abuse of racial minority populations by the health care system. Rather, the responsibility for addressing the consequences of centuries of injustice falls on the medical community to provide crucial evidence that establishes the trustworthiness of the health care system and to guide us toward achieving pharmacoequity (Warren et al. 2020).
Language Preference
As of 2010, 25 million people in the United States have a non-English language preference (NELP), and 57 million people speak a language other than English at home (Wilson 2013). Language barriers in health care lead to miscommunication between prescribers and patients and have been shown to reduce satisfaction, quality of health care delivery, and patient safety (Al Shamsi et al. 2020). Additionally, patients with NELP who need interpretive services but do not receive them receive lower-quality care (Flores 2005).
Language-discordant patients receive less health education and report worse interpersonal care (Ngo-Metzger et al. 2007). Language discordance also leads to lower prescription adherence for diabetes among NELP/Latinx patients than among non-NELP/Latinx and white patients (Fernández et al. 2017). However, interpretive services increase the use of clinical services and prescriptions written for and filled by NELP patients (Jacobs et al. 2001; Moreno, Tarn, and Morales 2009). Improving Medicaid and Medicare reimbursement for language assistance services, standardizing interpreter certification requirements, and ensuring access to printed and electronic patient instructions in multiple languages represent opportunities to improve pharmacoequity in this population.
Health Policy and Pharmacoequity
By shaping differential access to pharmacotherapy, health policies—from those affecting insurance coverage and regulating drug development to those determining locations of hospitals, clinics, and pharmacies—are significant determinants of racial disparities in pharmacotherapy access.
Health Insurance Coverage
Given the high and rising costs of prescription drugs in the United States, insurance coverage is fundamental to ensuring consistent pharmaceutical access. Individuals without insurance coverage face greater financial barriers to accessing prescription drugs (Lillard, Rogowski, and Kington 1999). Increased out-of-pocket costs—whether through lack of insurance or cost-sharing arrangements—manifest as decreased prescription drug utilization (Baicker et al. 2017; Goldman, Joyce, and Zheng 2007) and lower adherence (Gaffney et al. 2020; Piette et al. 2004).
Disparities in access driven by insurance coverage substantially contribute to racial inequities, and Black, Latinx, and Indigenous populations remain disproportionately uninsured (Artiga et al. 2021). Partly driven by disparities in income and employment (Sohn 2017), these insurance coverage disparities are rooted in the structural racism entrenched in American society. Additionally, although Medicaid—which predominantly insures Black and Latinx populations—covers most FDA-approved drugs, state utilization management programs (i.e., preferred drug lists, prior authorization, and step therapy) create barriers to access that result in differential receipt of certain therapies for Medicaid beneficiaries (NCHS 2015). These barriers include restricting eligibility for certain drugs and introducing delays in receipt of indicated therapies, potentially contributing to nonadherence, often without achieving the intended effect of enhancing quality of care (Sachs and Kyle 2022).
For individuals covered by managed care plans—including Medicare Advantage enrollees, managed Medicaid beneficiaries, and commercial or private insurance—preferred pharmacy networks may limit access to pharmacotherapies by reducing potential sites of access (Starc and Swanson 2021). Although network adequacy requirements (e.g., policies to ensure that sufficient numbers and types of prescribers are reasonably accessible without delay) are in place to regulate these pharmacy networks and improve access for beneficiaries, current measures are inconsistent. Across plans, network adequacy requirements are limited by the complexity of defining “adequacy,” resulting in significant gaps in medication coverage (DuGoff et al. 2016).
The Affordable Care Act
While some of our nation's most significant recent health care laws—the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which established Medicare Part D, and the Affordable Care Act (ACA) of 2010—have greatly expanded health insurance coverage and prescription drug benefits, coverage gaps remain that contribute to differential access to pharmacotherapy. Although the ACA narrowed racial disparities in insurance coverage (Baumgartner et al. 2020), disparities still persist, and in some cases coverage disparities have widened in states that did not adopt Medicaid expansion. In these states, the decision not to expand Medicaid created coverage gaps, resulting in a lack of affordable health insurance coverage for low-income Americans who would otherwise have received coverage under Medicaid had states expanded the program. In nonexpansion states, Black and Latinx adults account for 60% of the population that falls into these ACA coverage gaps (Lukens and Sharer 2021). Furthermore, undocumented immigrants are generally excluded from Medicaid and are also ineligible for coverage through the ACA's insurance marketplace. Republican attempts to repeal and subvert the ACA, including efforts to hinder individual insurance marketplace enrollment, greatly slowed and began to reverse gains in insurance coverage achieved during initial ACA implementation (Artiga 2020). Americans newly covered by plans acquired under the ACA increased their utilization of prescription drugs (Ghosh, Simon, and Sommers 2019), underscoring the impact of prescription cost on equitable pharmacotherapy access and confirming the need for policies that expand insurance coverage.
Medicare Part D
By offering prescription drug plans to Medicare beneficiaries, the implementation of Medicare Part D in 2006 lowered out-of-pocket costs, increased prescription drug utilization among older adults, and decreased cost-related medication nonadherence (Lichtenberg and Sun 2007; Liu et al. 2011; Schneeweiss et al. 2009; Yin et al. 2008). Moreover, Part D has enrolled significantly greater proportions of Black (66%) and Latinx (71%) Medicare beneficiaries relative to white (55%) Medicare beneficiaries (though this difference may be influenced by higher rates of employer-sponsored supplemental coverage among white beneficiaries), and a greater proportion of racial minority enrollees receive low-income medication subsidies (Fields 2016). However, racial disparities in cost-related nonadherence (Holmes et al. 2012; Hussein et al. 2016; Lauffenburger et al. 2014) and in access to health care have persisted after Part D implementation. Furthermore, disparities in beneficiary experience have emerged, with Black nonenrollees reporting greater confusion about plan options (Skarupski et al. 2009) and Asian/Pacific Islander, Black, and Latinx beneficiaries experiencing greater barriers to receiving coverage information (Haviland et al. 2012).
Once enrollees reach the Part D coverage gap—i.e., the “donut hole,” or the range of prescription drug spending exceeding initial coverage limits but before catastrophic coverage—rates of medication discontinuation and cost-related nonadherence are greater among Black and Latinx beneficiaries than among white beneficiaries (Bakk 2015a; Zissimopoulos et al. 2015). Indicative of the cost sensitivity of these disparities, Black and Latinx beneficiaries are also more likely to restart their medications after their coverage resumes (Zissimopoulos et al. 2015).
Examining the impacts of the ACA and Medicare Part D on disparities in pharmacotherapy access underscores the broader truth that health policy is discriminatory, even if it is not designed to be. The racialized politics of Medicaid expansion (Michener 2020) and the social determinants driving the disparities that emerged in Part D implementation have likely restrained these policies from fully achieving their intended impact. We must recognize that health care policies do not operate in a vacuum; they intimately interact with, and must account for, the social structures and barriers of the society in which they function.
The Path Toward Achieving Pharmacoequity
Achieving pharmacoequity will require bold solutions that address the health and social policy, research infrastructure, and prescriber- and patient-level determinants described above. Attaining this goal will also require innovative policy solutions that address racial inequities in incarceration, immigration policy, access to mental health treatment, exposure to pharmaceutical advertisements, neighborhood factors, and myriad cultural factors that are not outlined in this article and warrant additional exploration. Furthermore, a deeper understanding of the role of drug pricing regulation in equitable pharmacotherapy access, including through payors and pharmacy benefit managers as well as private insurers and pharmaceutical companies, is needed.
Nonetheless, there are pressing strategies we must adopt to achieve pharmacoequity. First, we must address the ever-rising cost of pharmacotherapy in the United States. Proposed solutions to reduce cost, constrain price growth, and enhance prescription coverage are ongoing in Congress (Feldman et al. 2021) and have included direct drug price negotiation by the federal government, improving Medicare Part D drug benefits for low-income beneficiaries (Dusetzina, Keating, and Huskamp 2019), prescription drug importation, and international reference pricing. The passage of the Inflation Reduction Act in 2022 has allowed some of these proposals to achieve fruition, and it offers a promising opportunity to begin closing disparities in access to pharmacotherapy. Second, we must provide universal, low-cost prescription drug coverage that fills gaps for the insured and provides medication coverage to the millions of uninsured, many of whom are racial minority Americans. Beyond closing the Medicaid coverage gap, achieving this goal may include increasing access to lower-cost treatment options through the promotion of generic and biosimilar drug entry via improved patent policy and FDA regulation. Third, we must reimagine access to pharmacotherapy beyond improving insurance coverage. This will include increasing physical access to pharmacies; reducing barriers in access to medical specialists who are more likely to prescribe newer, evidence-based therapies; and improving pharmacy network adequacy requirements (Landon et al. 2021). Finally, we must invest in improved community engagement for pharmacotherapy management. Understanding the barriers to and facilitators of medication use and adherence in traditionally underserved communities is a critical first step to reducing treatment disparities. We must further invest in shared decision-making support tools, patient navigators, community health workers, and caregiver support to enhance patient engagement in their medical care. Implementing these structural solutions will be key to achieving a more equitable health system.
Conclusions
Access to prescription drugs in the United States is shaped by deeply entrenched inequities. Nevertheless, there are important opportunities to address these longstanding inequities in care, including access to pharmacotherapies. Improving access is particularly critical in the care of racial minority communities, who for centuries have suffered a disproportionate burden of disease and have often had greater need for prescription therapies. Achieving pharmacoequity will require eliminating racial disparities across the therapeutic cascade, from drug development in clinical trials to drug distribution at the local pharmacy. Pharmacoequity is key to the future health of our society, and through bold policy and social solutions, we can achieve it.
