Situations predisposing primary care patients to use antibiotics without a prescription in the United States

Background: Patients’ situations can impact their intentions to use antibiotics without medical guidance (non-prescription use) in the future. This survey determines the prevalence of intended (future) use of non-prescription antibiotics for 13 predefined situations and identifies the sociodemographic characteristics associated with intended use for these types of situations. Methods: Patient surveys (N = 564) were conducted from January 2020 to June 2021 in the waiting rooms of 6 safety-net primary care clinics and 2 emergency departments in a private healthcare system. We used principal component analysis to identify 3 situational summary factors: barriers to a doctor visit, accessibility of non-prescription antibiotics, and previous symptom relief with antibiotics. Multivariate linear regression identified the sociodemographic predictors associated with each summary factor. Results: The most common situations triggering patients to use non-prescription antibiotics were a perceived high cost of doctor visits (29.8%), having leftover prescription antibiotics (50.4%), and experiencing symptom relief with prior use of antibiotics (47.5%). Multivariate regression results revealed that younger patients (P < 0.04) and patients attending the safety-net health system (P < 0.001) had more intended use of non-prescription antibiotics for all 3 summary factors. Conclusions: Future stewardship interventions should consider the types of situations that drive patients’ decisions to use antibiotics without a prescription. Interventions aimed at reducing barriers to health care (eg, high costs and long waits associated with doctor appointments) and educating individuals on medically appropriate, nonantibiotic treatment options may reduce antibiotic use and antimicrobial resistance.


Introduction
1][12] Non-prescription antibiotics were obtained from leftover/previously prescribed courses, friends/relatives and social networks, stores and markets in the United States (illegally sold), over-the-counter sales in other countries, and Internet sources. 10,13,14revious studies have found that antibiotic misuse is influenced by patient and healthcare system determinants. 9,10,13,14Patient-level factors include younger age, lower education levels, using antibiotics in the past, and storing antibiotics in their homes. 9,10,13,14Healthcare system factors included having poor access to health care (eg, high healthcare costs, transportation problems) or difficulties with medical visits (eg, long clinic waits to be seen by the clinician or to get an appointment). 13,14][17] Large-scale surveys investigating the independent effects of social factors on patients' decisions to use antibiotics without a prescription are lacking in socioeconomically and linguistically diverse US-based primary care settings.Our study aimed to (1) determine the prevalence of intended (future) use of nonprescription antibiotics for 13 predefined situations and (2) identify the social and demographic predictors associated with intended use for these types of situations in diverse outpatient settings.

Design
A cross-sectional survey on non-prescription antibiotic use was conducted in Texas between January 2020 and June 2021. 10urveys were administered by trained research coordinators in the waiting rooms of 6 public, safety-net primary care clinics (eg, 3 continuity and 3 same-day/walk-in) and 2 private emergency departments (EDs) that serve racially, ethnically, and socioeconomically diverse patients. 10cruitment Clinic personnel provided recruitment flyers to each participant who checked in for a primary care visit. 10Interested adult patients volunteered to be surveyed anonymously.Individuals under 18 years old or adults who were unable to answer the survey questions were excluded. 10All patients were offered a $15 incentive for their time. 10

Survey
The survey interviews (Appendix 1) were conducted in person (when permitted during the pandemic) or remotely (via teleconferencing) in the patients' preferred language (English or Spanish).Additional survey details (eg, design, recruitment, and survey guide development) are published elsewhere. 10

Survey variables
To assess patients' endorsement of non-prescription antibiotics (intended use) in various situations, we queried, "If you were feeling sick, would you take antibiotics in the following situations without contacting a doctor/nurse/dentist/clinic?"Each patient was then presented with 13 predefined items/situations, 18 ranging from "You have leftover antibiotics at home from a previous prescription" to "Antibiotics are cheaper than over-the-counter cold and flu medications" (Appendix 1).Each situation/item was discussed and iteratively designed with input from the clinical staff, a consultant in linguistic and cultural competency for Hispanic communities, a health literacy expert, and our patient advisory board at the safety-net clinics to ensure applicability to this patient population. 10Patients could respond with "yes," "no," or "I don't know" after each situation was presented to them.Individuals who reported "yes" to any of the situations were scored as endorsing non-prescription antibiotic use.
Patients' sociodemographic factors were also assessed (Table 1).These sociodemographic factors included patients' age, gender, race and ethnicity, education level, health insurance status, healthcare system, health literacy, and language preference.Race and ethnicity categories included non-Hispanic Black/African American, Hispanic or Latinx, non-Hispanic White, and other.Education levels included less than high school, high school or GED, or some college and above.Health insurance status included private or Medicare, public or Medicaid or county financial assistance program (CFAP), and self-pay.The CFAP includes those patients who have benefits from Harris County, which allows access to public clinic providers at either very low or no cost.Health literacy was assessed using a brief screening tool by Chew and colleagues. 19,20

Ethics
This study was approved by the Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals (protocol H-45709).

Statistical methods
Comparison of prevalence of intended use between safety-net clinics and private EDs χ 2 tests for categorical variables were used to determine if there were any significant differences among 13 situations between the private and public safety-net healthcare systems.A P value of <0.05 was considered significant (Table 2).

Situational summary factors scores
We used principal components analysis (PCA) to demonstrate the dimensionality of the 13 situations (items).We used PCA as a data reduction technique and confirmed the factor structure underlying these situations, identifying distinct "summary factors."Smaller composite summary factors were created for items with high correlation (item factor loading >0.6) (Table 3).Three distinct situational summary factors (consistent with the conceptual basis) emerged from the 13 situations/items entered, including (1) barriers to a doctor's visit (Cronbach's α = 0.96; mean inter-item correlation [IC] = 0.79), (2) accessibility of non-prescription antibiotics (Cronbach's α = 0.81; mean IC = 0.48), and (3) previous symptom relief with antibiotics (Cronbach's α = 0.95; mean IC = 0.9) (Table 3).
Each patient was assigned a composite score for each situational summary factor by using the sum of all "yes" responses to each of the situations/items per summary factor.Scores >0 indicate that the patient answered yes to one or more situations within each summary factor.For example, a patient with a score of 0 for summary factor 1 would indicate that they did not experience any barriers to a doctor's visit (Table 3).Furthermore, each situational summary factor and the patients' composite scoring were determined as described below.
Summary factor 1. "Barriers to a doctor visit" included 6 items relating to the patients' (1) work responsibilities, (2) family responsibilities, (3) access to transportation, (4) ability to get a convenient appointment time, (5) difficulty getting an appointment with the doctor when sick, and (6) the perceived cost of the visit (Table 3).Each patient was assessed on a scale of 0-6.For example, a patient's summary factor 1 composite score of 0 indicated they did not answer "yes" to any situations/items related to the barriers to a doctor visit, and 6 indicated they responded "yes" to all the situations/items presented (Table 4).
Summary factor 2. "Accessibility of non-prescription antibiotics" consisted of 5 items relating to patients' having (1) leftover antibiotics in their possession, (2) non-prescribed antibiotics given to them by friends or relatives, (3) purchased antibiotics without a prescription in the United States, (4) purchased antibiotics abroad, and (5) beliefs that antibiotics are less expensive than over-thecounter cold and flu medications (Table 3).Each patient was assessed on a scale of 0-5.For example, a patient's summary factor 2 composite score of 0 indicated they did not answer "yes" to any situations/items related to the accessibility of non-prescription antibiotics, and 5 indicated they responded "yes" to all the situations/items presented (Table 4).
Summary factor 3. "Previous symptom relief with antibiotics" included two items: (1) the patient got better by taking an antibiotic in the past, and (2) the doctor prescribed the patient an antibiotic in the past for the same or similar symptoms (Table 3).Each patient was assessed on a scale of 0-2.For example, a patient's summary factor 3 composite score of 0 indicated they did not answer "yes" to any situations/items related to previous symptom relief with antibiotics, and 2 indicated they responded "yes" to all the situations/items presented (Table 4).

Linear regression models
Multivariate linear regressions were performed for each summary factor (outcome) to determine the patient-level factors associated with the situations that influence patients' endorsement of nonprescription use.Predictors for each model included sociodemographic variables that were significant in univariate analyses at the P < 0.2 level (Table 1).Other includes mixed race (Black/African American and Hispanic or "Afro-Latin") and Asian.c The county financial assistance program includes those patients who have benefits from a county, which allows access to public clinic providers at either very low or no cost.d Individuals endorsing (answering "yes") having difficulty understanding written information, confidence in filling out medical forms by themselves, and someone helps them read clinic or hospital materials. 19,20 Patient gender, race and ethnicity, education level, insurance status, language preference, and health literacy level were insignificant predictors in this model (Table 5).

Discussion
Our study revealed alarmingly high proportions of patients endorsing intended non-prescription antibiotic use across all 13 predefined situations.Up to half (30-50%) of all patients surveyed expressed an intention to use antibiotics without a prescription for situations involving high doctor visit costs, possessing leftover prescription antibiotics, and having experienced prior symptom relief when using antibiotics.In addition, our adjusted results found that younger patient age and receiving care from the safetynet clinics was associated with increased intention to use nonprescription antibiotics across all summary factors (ie, perceived barriers to a doctor visit, accessibility of non-prescription antibiotics, and previous symptom relief with antibiotics).The high percentage of patients intending to use leftover antibiotic courses (50.4%) or using antibiotics because their doctor had prescribed it previously (49.6%) highlights the ongoing, systemic problem of overprescribing.2][23] Some of this prescribing behavior is driven by perceived patient expectations of receiving antibiotics. 24dditionally, the large percentage of patients reporting prior symptom relief with antibiotic treatment (47.5%) indicates a substantiated need for additional education on appropriate antibiotic use for patients.Other studies show patients' trust in primary care professionals' clinical advice, including willingness to consider alternative/nonantibiotic treatment options if counseled appropriately and involved in shared decision-making regarding antibiotics. 25,26In addition, patient-provider counseling focused on the individual (patient-level) adverse outcomes (eg, Clostridioides difficile infection and severe drug interactions/ complications) may resonate with patients and may have more individual relevance than discourse about societal harms or antibiotic resistance resulting from inappropriate antibiotic use. 5,27ur findings also highlight that younger patients report higher intentions to use non-prescription antibiotics for situations related to healthcare system barriers, accessibility of non-prescribed antibiotics, and beliefs that antibiotics will alleviate symptoms experienced.9][30] Younger patients may have lower knowledge around antibiotics, resistance, and how to care for self-limiting infections than older patients.Additionally, younger patients may not have an established primary care doctor compared with older patients.

Limitations
Despite having a large, diverse outpatient sample with representation across healthcare systems, including public primary care clinics and private EDs, our study findings may not be generalizable to all US-based patient populations.However, other large US cities with demographics similar to that of Houston may have similar results.For instance, the Rice University Kinder Institute projected that by 2040, most US cities will resemble the sociodemographics of the greater Houston metroplex. 31dditionally, our survey relied on self-reporting; thus, a social desirability response bias may have occurred despite our best efforts to phrase questions neutrally.Some patients may not disclose their antibiotic use without a prescription due to stigma, discrimination, or legalities surrounding the practice.Moreover, the coronavirus disease 2019 pandemic and quarantine may have introduced unintended contextual changes that may have impacted responses.Finally, because patients were surveyed in the healthcare setting, they may be more prone to seek healthcare advice, and these results may be an underrepresentation of the true burden of non-prescription antibiotic use.More research is needed to expand on these results and investigate these factors in other geographically, racially, ethnically, and linguistically diverse study populations in the United States.
Our results broadly align with the priorities of the United States Government Office of the Assistant Secretary for Planning and Evaluation (ASPE). 32The ASPE reports that patients' social factors can negatively impact over 50% of their health outcomes. 32The ASPE encourages integrating patients' social situations into public health, health care, social services, and other governmental institutions in collaboration to advance health equity and improve patient health outcomes and well-being. 32In addition, in a recent survey of over 1,500 US physicians, social factors adversely impacted patients' health behaviors and outcomes. 33pproximately 77% of the surveyed physicians stated that all or many of their patients had reported at least 1 social determinant that adversely impacts their health care, with financial instability (34%) and transportation (24%) being the most frequently reported social factors, according to patients. 33ntibiotics in future interventions.Future policies and antibiotic stewardship interventions should consider improving patient access to health care and tailoring education focused on safe antibiotic use.Clinicians may choose to provide medically appropriate, alternative (nonantibiotic) treatment options and information to patients experiencing certain symptoms where antibiotic treatments may not be warranted.

Table 1 .
Patient sociodemographic characteristics by healthcare system.Differences between the public safety-net and private healthcare systems (P < 0.05) are significant a Boldface indicates statistical significance (P value <0.05).b

Table 2 .
Patient-reported intended use for each situation by the healthcare system a Boldface indicates statistical significance (P value <0.05).

Table 3 .
Dimensionality of the 13 situations/items, including item factor loadings and reliability statistics per situational summary factor