Disparities in drug safety practices in developing nations: focusing on underlying factors and implications for global health

KEYWORDS:

• Adverse drug events
• reporting of medication issues
• patient safety

1. Introduction

Health disparities encompass variations in health outcomes and access to healthcare services among various groups of people [1]. Disparities in drug safety refer to discrepancies in rates of adverse drug events (ADEs), comprising medication errors (MEs) and adverse drug reactions (ADRs), across diverse populations [2]. According to the World Health Organization (WHO), ADR refers to ‘A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function’ [3].

Only a few studies have explicitly investigated disparities in preventable ADEs, and most of these studies were conducted in the United States (US). An example of drug safety disparities can be seen through a systemic review that found women and black patients were more prone to encountering MEs [4]. According to another US study, the rates of ADEs varied among hospitalized children from different socioeconomic and racial backgrounds [5].

Drug safety disparities have serious consequences, ranging from hospitalization and disability to mortality [6]. Furthermore, they contribute to rising healthcare costs due to additional interventions being necessary; affected populations also experience reduced trust in healthcare systems further entrenching existing inequities in health. As a result, disparities in disease burden and treatment outcomes vary significantly based on factors like race ethnicity socioeconomic status geographic location, creating ethical dilemmas as providers strive to provide equitable care for all individuals [5].

Although drug safety disparities are a pressing global problem, developing nations bear an inequitable share. Often, these nations are characterized by a lack of resources, an inadequate healthcare system, and socioeconomic issues. They struggle to guarantee the safety and efficacy of medical products and drugs used in their country. War conflicts, culture, beliefs, social stigma and other factors can also have a significant impact on the disparities of drug safety in these countries.

Unfortunately, few research efforts are dedicated to understanding and addressing this critical issue; ‘drug safety disparities’ is rarely mentioned in literature. Therefore, this editorial seeks to bring light on evidence of drug disparities in developing nations as well as explore their underlying factors, and implications for global health outcomes.

2. Evidence of drug safety disparities in developing nations

One evidence of drug safety disparities in developing countries is the scarcity of medication safety research on particular groups, such as refugees, women, elderly individuals, and other marginalized populations.

To select examples of drug safety disparities in this editorial, we employed a focused strategy to identify relevant literature. While this editorial is not a systematic review, we utilized specific keywords related to healthcare disparities, refugee health, and regional healthcare challenges in databases such as PubMed, Google Scholar, and relevant humanitarian reports. Our aim was to illustrate the varied nature of healthcare disparities in different contexts.

Although Syrian refugees in Jordan represent approximately 13% of the total population, there has been limited research conducted on medication safety within this group. Only one study, conducted by Hammad et al. in 2022, focused on measuring drug related problems (DRPs) among refugees. The study screened 1530 refugees with chronic conditions in Al Zaatari Camp and found that DRPs occurred at a rate of 2.3 per patient [7]. It is worth noting that the mean number of medications taken by these refugees was only 4, whereas studies conducted in the host community showed a mean number of medications exceeding 8, with higher DRP rates compared to those found among refugees [8]. This example highlights differences in medication safety challenges faced by populations living in developing nations like Jordan, compared to developed nations such as Switzerland or Canada. It also sheds light on within-country disparities, such as those between refugees and host communities. By including this comparison in its research design, this example aims to offer an in-depth examination of all the factors influencing medication safety across different economic settings. Its findings play a vital role in designing interventions and policies targeted at improving medication safety globally, while taking particular notice of the needs of vulnerable groups in both developing and developed nations.

Medication errors in developing countries tend to occur more frequently in rural or underserved areas with limited healthcare resources and access to qualified healthcare providers [9,10]. Furthermore, elderly patients are particularly prone to dispensing errors because of polypharmacy, complex medication regimens, cognitive impairment and age-related cognitive decline [10].

Studies conducted in Iran and Brazil also demonstrated discrepancies in prescribing and use of medicines depending on economic status, socio-economic status and place of residence [11,12]. These results illustrate how factors like economic inequality or place of residence contribute to disparities in access or use of medication. A Malawian study demonstrated gender inequities when prioritizing medical treatments over other priorities, providing further proof that gender disparities exist with regards to medication access and safety practices [13].

3. Expert opinion

This editorial shed light on evidence factors behind drug safety disparities among developing nations, emphasizing that these disparities not only limit access to healthcare but also lead to higher adverse drug event rates among different population groups. Furthermore, this editorial draws the attention to the lack of research dedicated to understanding drug safety disparities and addressing them in developing nations. It also discusses the impact of disparities in drug safety among developing nations on global health.

Systemic, institutional, and individual factors all can impact differences in medication safety practices among different groups in developing nations. These factors along with examples are described in Table 1.

Table 1. Underlying factors of Drug Safety Disparities in Developing Nations.

Category	Factor	Description	Example
Systemic	Governance and policy challenges	Weak governance, corruption, and inadequate healthcare policies and regulations can have detrimental effects on, drug safety.	Without proper accountability and consequences for not meeting quality standards, certain patient groups could experience subpar care, as well as barriers in accessing safe therapy processes.
	Health infrastructure	Disparities in healthcare infrastructure can affect drug safety. Rural areas may have limited healthcare facilities, including hospitals, clinics, and pharmacies.	Disparities in healthcare infrastructure lead to limited access to essential medications and trained healthcare providers, increasing the risks of medication errors due to poor storage conditions for drugs or insufficient monitoring/surveillance systems for adverse events caused by prescription medicines.
	Health financing	Inadequate health financing can contribute to drug safety disparities by affecting basic needs and supplies	Remote rural regions often lack sufficient health financing. Without enough money available for essential medicines purchases and implementation of quality control measures. Furthermore, providing healthcare personnel with adequate training is sometimes impossible due to limited funds available for training purposes.
	health information systems	Discrepancies in health information systems can impact drug safety monitoring and reporting.	Rural areas or refugee camps may lack access to electronic medical records, pharmacovigilance systems and adverse event reporting mechanisms.
	Pharmacovigilance Systems	Lack of comprehensive pharmacovigilance systems in developing countries hinders monitoring and reporting of adverse drug reactions and medication errors.	Developing countries often lack a national system for adverse drug reaction reporting (such as a ‘yellow card’ system). This leads to underreporting of drug-related issues and a lack of data for improving drug safety. Additionally, there may be a shortage of trained professionals and inadequate technology for effective pharmacovigilance.
Institutional	Medication Management Policies	Variation between healthcare institutions’ medication management policies can result in diverse medication safety practices and cultures within healthcare facilities can also contribute to these disparate approaches to safety.	Institutions with varying medication safety policies, which govern prescribing, dispensing, administering, and monitoring of medicines, can experience different rates of medication errors and adverse drug events. Differences in these policies can significantly impact the safety and efficacy of medication management, leading to variations in patient outcomes across different healthcare settings.
	Medication Safety Culture	Staffing levels and training of healthcare professionals may impact medication safety practices. Furthermore, technological resources within hospitals may have an effect on these measures as well.	Institutions with weak medication safety cultures may place less importance on reporting and learning from errors, leading to missed opportunities for improvement and variation in medication safety practices.
	Staffing and Training	Health literacy refers to an individual’s capacity to effectively understand and use health information for informed healthcare decision-making, adherence to prescriptions is crucial in maintaining medication safety and effectiveness.	Institutions faced with staff shortages or lacking adequate training may struggle to effectively implement medication safety protocols, increasing their risks of medication errors and adverse drug reactions.
	Technology	Cultural beliefs and practices may influence medication safety and use patterns among older adults, who often suffer from multiple chronic illnesses that require complicated medication regimens that increase the risk of polypharmacy and medication errors.	Institutions equipped with appropriate technologies – like electronic prescribing systems, barcode scanning devices and medication reconciliation tools – are better placed to prevent medication errors and ensure safe medication practices.
Individual	Health Literacy	Medication affordability refers to individuals being able to afford and access medications prescribed to them; while prejudice refers to preconceived judgments or discriminatory attitudes held by healthcare professionals toward specific population groups.	Individuals with limited health literacy may struggle to comprehend medication labels or follow complex dosing instructions, increasing the risk of improper drug usage.
	Adherence to Medication Regimens	Variation between healthcare institutions’ medication management policies can result in diverse medication safety practices and cultures within healthcare facilities can also contribute to these disparate approaches to safety.	Socioeconomic factors, including limited access to transportation or financial constraints, may prevent individuals from getting their medications on schedule and on schedule; leading to inconsistent use and therapeutic disruption.
	Cultural Beliefs and Practices	Staffing levels and training of healthcare professionals may impact medication safety practices. Furthermore, technological resources within hospitals may have an effect on these measures as well.	Individuals from certain cultural backgrounds may rely on alternative medicinal remedies or self-medication practices that increase the risk of drug interactions or side effects.
	Age-related Factors	Health literacy refers to an individual’s capacity to effectively understand and use health information for informed healthcare decision-making, adherence to prescriptions is crucial in maintaining medication safety and effectiveness.	Senior adults may be more at risk of falls or cognitive impairment, which could compromise their ability to follow instructions for medication administration and detect adverse side effects.
	Medication Affordability	Cultural beliefs and practices may influence medication safety and use patterns among older adults, who often suffer from multiple chronic illnesses that require complicated medication regimens that increase the risk of polypharmacy and medication errors.	Rich individuals with enough disposable income to easily pay their prescription medications are assured a steady supply of quality drugs from trusted suppliers.
	Prejudice	Medication affordability refers to individuals being able to afford and access medications prescribed to them; while prejudice refers to preconceived judgments or discriminatory attitudes held by healthcare professionals toward specific population groups.	If a healthcare professional holds discriminatory assumptions or stereotypes against certain ethnic or racial groups, this can result in differential treatment, miscommunication and reduced trust between patients.

Governance and policy issues such as inadequate regulation, insufficient transparency and lack of accountability are systemic problems that must be resolved for good governance to exist [14]. Regulations which fail to address the specific needs and challenges encountered by some patient groups such as women or children could result in disparities when it comes to access to safe medications of high-quality standards.

In developing countries, healthcare infrastructure, funding, and information systems do not distribute equally resulting in unequal drug safety practices across different facilities and practices [15–19]. Rural areas struggle with limited facilities and skilled professionals affecting care quality, leading to more medication errors due to inadequacies of funding which limit accessibility of medications, quality controls and training tools [15]. Rural healthcare systems and refugee camps with insufficient healthcare systems often experience delays when responding to errors when prescribing and dispensing medications, due to limited use of electronic records, pharmacovigilance monitoring, or adverse event reporting, making correcting errors quickly difficult as is monitoring any ADRs.

Individual factors play a central role in determining drug safety disparities across population groups in developing countries. Poor health literacy skills may result in miscommunication or mistakes when administering medications [20]. Adherence issues that are driven by socioeconomic influences can contribute to inconsistent medication use and negative health consequences, cultural beliefs and practices can impact its safety, while financial restrictions also pose threats. Rich people can afford more easily purchase prescription medicines from reliable sources and this gives them access to high-quality medication at more reasonable costs. Poor people may struggle to access affordable medications, leading them to use counterfeit or substandard products more likely to cause side effects. Prejudice among health professionals may further contribute to disparities among populations when it comes to drug safety; prejudicial attitudes could contribute to unequal treatments, miscommunications and lack of trust that undermine culture competence as well.

Competency among health professionals plays a pivotal role in drug safety and can both be considered individual and institutional factors that create discrepancies in drug safety levels.

Individual factors, including knowledge and skills, experience and adherence to best practices can have an enormous effect on a professional’s ability to prescribe, dispensing, administer and monitor medications accurately [20]. A lack of training, outdated knowledge or inappropriate application of protocols could result in errors during dispensing or administration that create disparities of drug safety.

Competency is also affected by institutional factors. The healthcare institutions have a vital role to play in establishing a culture for safety, providing resources and training, and implementing guidelines and protocols based on evidence [20]. Institutions which prioritize continuous education, training and quality improvement programs can enhance the competence of healthcare professionals. Institutions that do not provide adequate resources or infrastructure to support continuing education and train healthcare professionals may lead to disparities in their competency, resulting in variations in drug safety.

The paucity of drug safety data from developing nations, which constitute a significant portion of global medication usage, is a critical issue impacting the global pharmacovigilance landscape. It is important to acknowledge the underrepresentation of data from these nations in the current drug safety knowledge base. This presents a significant limitation, as these countries account for a large portion of global medication use. Suboptimal pharmacovigilance systems in developing countries hinder the identification and reporting of ADRs. Consequently, our understanding of safety profiles may be skewed toward experiences observed in high-income countries, potentially overlooking important drug-related risks relevant to developing nations’ populations. Further research efforts are urgently needed to strengthen pharmacovigilance systems in these nations and ensure wider representation of their experiences in the global drug safety database. Integrating data from developing nations is crucial for generating a more comprehensive and generalizable understanding of drug safety, ultimately leading to safer and more effective medication use for all populations.In my opinion, the rapid advancement of social media and increased international travel have amplified the consequences of drug safety disparities in developing countries, extending their impact beyond national borders. These interconnected factors have brought about significant changes in the way information is disseminated and individuals interact globally. As a result, the implications of drug safety disparities are no longer confined to the countries where they originate but have far-reaching effects on a global scale. Global health security is closely intertwined with drug safety. Infectious diseases can easily cross borders, and the spread of medication-related adverse events poses a threat to public health worldwide. Drug-resistant infections, substandard or counterfeit medications, or improper use of medications in one country can have implications for neighboring countries and even extend to regions far away. The interconnectedness of healthcare systems and the movement of people and goods emphasize the need for collective efforts in addressing drug safety disparities globally.

Addressing drug safety disparities in developing nations necessitates a comprehensive, multidimensional strategy, including:

• Establishing robust drug regulatory bodies to ensure medications comply with international standards through rigorous testing and vigilant monitoring.

• Enhancing healthcare infrastructure in underserved regions, integrating state-of-the-art tools, and ensuring a consistent supply of essential medications.

• Deploying Artificial Intelligence (AI) to analyze extensive datasets and pinpoint regions most impacted by drug safety disparities.

• Leveraging the vast reach of social media to facilitate the dissemination of accurate drug information and garner real-time feedback.

• Ongoing education of healthcare professionals, tailored to drug safety practices, coupled with public health campaigns to elevate health literacy and foster appropriate medication practices.

• Engaging in collaborations with international health organizations for expertise, resources, and training.

• Instituting pharmacovigilance systems for the continuous evaluation of drug safety.

• Addressing socioeconomic challenges and underscoring cultural competence in healthcare to bridge the disparities gaps.

To sum up, for an effective response to disparities between developed and developing nations in drug safety monitoring practices, a multifaceted strategy must be employed. At its heart is the establishment and strengthening of pharmacovigilance systems – vital tools in assuring drug safety over time. Given the regional variations in pharmacovigilance network development, collaboration among global health organizations, such as WHO, is needed. These efforts should focus on providing resources, guidance, and support for countries with less developed pharmacovigilance infrastructures. By working toward harmonizing global drug safety standards and narrowing gaps between established systems, such as AERS (American Adverse Event Reporting System), EudraVigilance in Europe, and the UK’s Pharmacovigilance system, and those in other nations’ systems, such efforts would not only strengthen drug monitoring in developing nations but also contribute toward overall improvements in global health security.

4. Conclusion

Drug safety disparities in developing nations are a pressing issue that requires further research. The factors contributing to these disparities are complex and encompass individual, institutional, and systemic elements. These disparities not only compromise the well-being and safety of individuals within these nations but also have far-reaching consequences beyond their borders.

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.

Author contribution statement

All authors contributed to the following: conceptualization of the study design, extracted data, analyzed data, and drafted the manuscript.

Additional information

Funding

This paper was not funded.