Adverse drug event reporting among women: uncovering disparities in underserved communities

KEYWORDS:

• Drug safety
• adverse drug events
• adverse drug reactions
• medication errors
• women

1. Introduction

Adverse drug events (ADEs), including preventable medication errors (MEs), and non-preventable adverse drug reactions (ADRs), pose a significant healthcare challenge due to their potential risk of patient harm [1]. The underreporting of ADEs is an increasingly urgent issue in healthcare, occurring when healthcare providers, patients, or pharmaceutical companies fail to report harmful medication reactions fully [1]. There are complexities in the reporting disparities of adverse drug events among underserved populations, especially women. This demographic faces unique healthcare challenges, such as limited access to quality care, financial constraints, intimate partner issues, and reduced health education [2]. Despite this, there is a notable dearth of research focusing on ADE reporting within these communities.

Studies from developed countries are shedding more light on gender disparities in adverse event reporting. For instance, a South Korean study on antidiabetic drugs revealed significant disparities between genders, with women reporting more adverse events than men [3]. This trend was particularly pronounced with newer medications, highlighting the need for gender-specific research in pharmacovigilance. On the other hand, a Dutch study indicated that although women report more ADRs overall than men (or vice versa), men tend to report more serious and fatal ADRs [4].

This editorial aims to critically analyze the current landscape of ADEs among women from underserved populations. We intend to identify the challenges and barriers in accurately reporting and treating such reactions, while proposing potential solutions that could improve healthcare outcomes for these vulnerable groups. Through this analysis, our goal is to contribute to the broader conversation around pharmacovigilance, advocating for more nuanced and inclusive approaches that consider both gender and socioeconomic status in healthcare decisions.

2. Current evidence

Our review of literature revealed no studies specifically focused on investigating gender disparities in the reporting of adverse drug events (ADEs). However, numerous studies suggest that women are more susceptible to experiencing ADEs than men, though few have directly examined this aspect. For instance, a study conducted in a rural area of India showed a notable difference, with an odds ratio (OR) of 1.52 (95% CI: 1.04–2.22), as reported by a research team [5]. Similarly, an emergency department in Belgium observed a higher incidence of such events among female patients [6]. Additionally, research focusing on cancer patients demonstrated a significantly higher likelihood of women experiencing adverse drug events [7]

A global study found that, of all reports including gender information, 60.1% (9,056,566 reports) involved females, while 39.9% (6,012,804 reports) pertained to males, suggesting a higher number of ADR reports from female reporters worldwide [4]. However, this study did not consider women in communities where ADR reporting is less accessible. Analysis of a 13-year dataset from the Netherlands using spontaneously reported ADRs revealed significant gender disparities. Out of 363 drug-ADR combinations with gender-differentiated reports, 322 (89%) were more common in females. Certain ADRs, such as nausea, alopecia, headache, and dizziness, were more frequent in females, while males experienced ADRs like aggression, sexual dysfunction, and tendon rupture [8]. Women, often socialized to be more attentive and communicative regarding their health, may report ADEs more frequently than men, who might be inclined to underreport health issues. Social norms and healthcare usage patterns are closely linked. Women’s more regular engagement with healthcare systems, partly due to reproductive health needs, provides additional opportunities for ADE reporting. In contrast, men’s less frequent healthcare visits could lead to a lower detection and reporting rate of ADRs. Data from the U.S. FDA Adverse Event Reporting System (FAERS) corroborates this, showing a female bias in patient-reported ADRs compared to provider-reported cases. Reporting disparities also vary across ADE types; cosmetically significant and sexual dysfunction ADEs are more often reported by females, whereas men more frequently report cosmetically significant ones. This hypothesis highlights the potential for identifying intervenable mechanisms contributing to sex disparities in ADEs [9]. Gender differences in ADEs types are summarized in Table 1.

Table 1. Ades reporting across males and females.

Parameter	Females	Males
Common ADRs	Nausea, Alopecia, Headache, Dizziness	Aggression, Sexual dysfunction, Tendon rupture
Healthcare Engagement	More regular engagement due to reproductive health needs	Less frequent healthcare visits
Social Norms & Reporting	More likely to report due to being socialized to be more communicative about health	May underreport due to social norms and less communication about health issues
Reporting Bias	Possible underreporting due to gender bias and discrimination in healthcare	–
Economic Factors	May refrain from seeking help for ADEs due to healthcare costs	–
Cultural Barriers	Restrictions on seeking healthcare independently, more pronounced in certain communities	–
Stigma & Fear	Stigma around reproductive/sexual health ADEs; fear of not being taken seriously	–
Access in Rural Areas	Reduced mobility and health literacy issues, leading to underreporting	Possible disparity in healthcare access, leading to higher frequency of reporting in some cases

Contrastingly, a study from Uganda focusing on healthcare workers noted a lower likelihood of ADR reporting among women compared to their male counterparts, with an OR of 0.335 (95% CI: 0.159–0.706) [10]. There are several potential explanations for these findings. Gender bias and discrimination in healthcare settings complicate the situation further, as women’s symptoms and complaints are sometimes dismissed or misinterpreted, leading to an underdiagnosis of ADEs. Such experiences can deter women from reporting ADEs or result in their concerns being inadequately addressed. Additionally, economic factors related to healthcare costs add complexity [11]. In situations where healthcare is prohibitively expensive, those with limited finances, particularly female patients, may refrain from seeking medical help for ADEs, thus contributing to underreporting. Cultural barriers also play a significant role, often restricting women from independently seeking healthcare, a reality that is more pronounced in certain communities. Constraints imposed on women by male healthcare providers can significantly hinder their ability to report ADEs, causing many incidents to remain undetected and undocumented.

Stigma associated with specific ADEs, especially those concerning reproductive and sexual health, is another critical factor [12]. Discussing these topics can be taboo for women in some cultures, leading to delays in reporting ADEs. Fear is another influential factor in reporting ADEs. Concerns about not being taken seriously or facing judgment from healthcare providers may discourage individuals, especially women, from reporting an ADE. This fear could originate from prior negative experiences or perceived societal attitudes toward women’s health issues.

Moreover, women in rural areas with limited access to healthcare often face additional challenges. In these environments, women may encounter obstacles such as reduced mobility and health literacy issues that hinder their ability to report ADEs. Saikia et al.‘s recent study in India highlights the possibility of disparate healthcare access between genders, which might explain the higher frequency of male ADE reports [13].

3. Expert opinion

The research in pharmacovigilance, especially regarding how women in underserved populations report ADEs, exposes a significant gap. Findings suggest that women are more susceptible to ADEs, yet their reporting rates, particularly in underserved areas, are poorly documented. This highlights a critical weakness in current research: a lack of focused studies on the intersection of gender, socio-economic status, and healthcare access in ADE reporting. Existing studies are often too broad and fail to address the unique challenges faced by women in marginalized communities.

This editorial highlights a crucial gap in the evidence regarding ADE reporting by women from specific populations, pointing out a significant oversight. Because there is a need for healthcare policies that are inclusive and cater to the diverse needs of different population segments, I call, in this editorial, for comprehensive investigations into the sociocultural and economic factors that influence how women interact with healthcare systems, particularly drug safety systems.

Addressing this disparity is essential for creating an inclusive and equitable healthcare system. By recognizing and addressing the differences in ADE reporting between underserved and general populations, healthcare providers can formulate more inclusive pharmacovigilance strategies. These strategies should aim for equal gender and socio-economic representation in drug safety data, ultimately ensuring that all patients, regardless of their background, have equal access to safe medication practices and are adequately represented within drug safety data.

Collecting empirical evidence surrounding the reporting of ADEs among women from underserved populations is crucial to achieving this objective. We should focus on examining the patterns and barriers related to reporting ADEs, taking into consideration the cultural, economic, and social factors that affect health-seeking behavior and communication with healthcare providers. Nonetheless, conducting research in underserved communities poses a potential challenge; overcoming systemic biases and logistical obstacles that limit the scope of research, such as issues with healthcare access or the stigma associated with certain health concerns.

I believe that this field is likely to see an expansion in research that integrates gender and socio-economic factors into pharmacovigilance over the coming years. As personalized medicine gains prominence and health equity becomes a greater focus for healthcare providers and policymakers, there is an expectation for more in-depth studies into the needs and experiences of diverse populations. These studies may employ innovative methodologies, such as community-based participatory research, to directly engage with underserved groups.

Currently, digital health technologies are garnering interest as a means to enhance ADE reporting among underserved populations. Mobile health apps and telehealth services have the potential to bridge gaps in healthcare access and facilitate real-time reporting of ADEs for immediate intervention. During the COVID-19 pandemic, these technologies proved invaluable in providing essential medical services and overcoming traditional barriers to healthcare access for underserved populations [14–16]

4. Conclusion

This editorial emphasizes a significant gap in pharmacovigilance research, specifically focusing on how women from underserved populations report ADEs. Despite evidence suggesting that women are more prone to ADEs, there is a noticeable lack of research addressing the unique challenges they face within their communities. Consequently, there is a pressing need for more empirical research to understand the patterns and barriers related to ADE reporting among these women. Such research should integrate gender and socio-economic factors, as well as explore innovative solutions like digital health technologies. This approach aims to develop an inclusive healthcare system that ensures equal access to safe medication practices and fair representation in drug safety data. Addressing this issue is crucial in fostering an equitable healthcare system where all patients, regardless of their background, are equally represented in drug safety data.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.