Assessing the Impact of Language Access Regulations on the Provision of Pharmacy Services

Approximately 25 million people in the United States (US) are limited English proficient (LEP) [1]. Compared to English proficient persons, those who are LEP are more likely to have reduced access to care, have a limited comprehension of health information [2], report lower levels of satisfaction with health care services [3, 4], and may face higher medical costs due to unnecessary diagnostic testing [3]. Appropriate language services can improve care for LEP individuals [3, 4], and health care facilities receiving federal funds, including payments through the Medicaid and Medicare programs, are required—according to Title VI of the Civil Rights Act of 1964 [5, 6]—to provide such services [7].

Although language services are increasingly available in many health care settings [8‐10], several studies have demonstrated inadequate provision of language services in pharmacies. In research conducted in New York City (NYC) in 2006, we found that of pharmacies reporting that they had LEP patients on a daily basis, just 39% reported providing translated prescription medication labels daily and 23% never translated labels. Compared to independent pharmacies, chains were significantly less likely to provide translation services; seven of 65 (10.8%) chain pharmacies in our 2006 study regularly provided translated instructions, compared to 61 of 124 (49.2%) independent pharmacies. More than 80% of all pharmacies included in the study lacked systematic approaches for identification and documentation of linguistic needs and for informing patients of translation capabilities (e.g., language preferences indicated in electronic records, multilingual signage alerting customers to available services) [11]. Studies conducted elsewhere in the US report similar gaps in services [12‐14].

Recognizing the risks of inadequate comprehension of medication instructions, including poor adherence, errors, and adverse drug events [15], New York lawyers for the Public Interest and Make the Road New York led advocates in New York State (NYS) and NYC in grass-roots campaigns to mandate more systematic and comprehensive approaches to language access services within chain pharmacies. As a result of these campaigns, new regulations were adopted in NYC and NYS between 2008 and 2012 requiring that chain pharmacies provide translation and interpretation services for pharmacy patients speaking the most common non-English languages; however, a system for monitoring compliance by the State Pharmacy Board or other governing body was not included within the regulations. (see Table 5 for a summary of actions and resulting regulations) [16, 17].

The goal of this study is to characterize and assess the impact of language access regulations on services available to LEP patients. In this paper, we focus on capacity to provide written translation and oral interpretation of medication instructions, provision of translated materials, and systematic approaches to identifying language needs among NYC chain pharmacies.

This paper reports on surveys of NYC chain pharmacies, conducted in 2006 and 2015, and focused on translation capacity and practices, as well as observations of pharmacy signage conducted in 2015. It is part of a larger project on language services in chain pharmacies being implemented in NYS, New Jersey, and Connecticut, which includes surveys of chain pharmacies; structured observations of pharmacy signage; and surveys and education of LEP community members.

Our findings demonstrate that between 2006 and 2015 there was a significant improvement in the capacity of NYC chain pharmacies to provide language access services, consistent with NYC and NYS regulations adopted between 2008 and 2012 (Table 5). A significantly higher proportion of chain pharmacies surveyed reported being able to print translated medication labels, providing translated labels to LEP patients, access and use of telephone interpreter services, multilingual signage informing patients of language services, and documentation of language needs in patient records—all of which are requirements of the new regulations and laws adopted in New York. These findings illustrate the potential impact of grass-roots advocacy and resultant policy change on institutional practices that impact significant portions of the population.

Our ability to conduct surveys using similar protocols before and after the implementation of pertinent regulations and laws is a particular strength of this study. The significant change in chain pharmacy practices related to language access over just a few years is notable, given early concerns related to feasibility and liability exposure, which were expressed by pharmacists when we conducted our earlier study [11].

As far as we know, New York’s pharmacy language regulations are unique. The findings reported here could thus be useful in the development of similar policy efforts in other jurisdictions. Most of the pharmacies included in this study are part of multistate chains that have developed systems for the provision of language services. Promoting and utilizing those systems outside of New York, seemingly, could be accomplished with relative ease.

This study has several limitations. At both points in time, data were largely self-reported, and were therefore subject to recall errors and social-desirability bias. Although the reliability of recall should be similar for the 2006 and 2015 surveys, it is possible that, given the change in regulations, social-desirability bias may have been stronger in 2015. In addition, the pharmacist perspective represents just a part of the story: receipt of language-appropriate instructions by patients with limited English proficiency, improved comprehension, reduced medication errors, and better health are the ultimate goals. We have been surveying Spanish-speaking LEP patients as part of the larger study, to better understand their experience with language services in chain pharmacies and the implications thereof. Finally, similar research on chain pharmacies in other states is necessary to verify that the changes reported here were the result of New York regulations, rather than more general shifts in pharmacy practice. We are carrying out surveys and structured observations in communities in Connecticut and New Jersey (contiguous states to NYS) with high numbers of LEP residents to address this concern.

Despite these limitations, the significant changes documented in this study were largely consistent across the specific language services covered by the regulations. The results make a convincing case for the effectiveness of the laws and regulations implemented and for their adaptation in other states and municipalities.