1.1 Introduction
The rational use of antibiotics is defined as the situation in which patients receive antimicrobial medicines appropriate to their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and the community (World Health Organization, 2002). Antibiotics have remained one of the most significant medical discoveries, contributing immensely to the prevention and treatment of infectious diseases and improving global life expectancy. However, the benefits of antibiotics are increasingly threatened by the rapid rise of antimicrobial resistance, which occurs when microorganisms develop the ability to survive exposure to drugs that were previously effective against them (Prestinaci et al., 2015).
This chapter introduces the research by reviewing the background that informed the study, identifying the issues that led to its formulation, and outlining the aim and objectives. It also explains the study's significance, defines its scope, presents the research questions and hypotheses, addresses the limitations, and clarifies important terms used throughout the work.
1.2 Background of Study
Antimicrobial resistance has emerged as a major global public health concern, affecting both developed and developing countries. The inappropriate and excessive use of antibiotics in human medicine, agriculture, and pharmaceutical distribution systems is widely recognized as a key driver of this problem. Practices such as self-medication, over-prescription, use of substandard or counterfeit drugs, and failure to complete prescribed treatment courses contribute significantly to the selection and spread of resistant strains of bacteria (Laxminarayan et al., 2013). As resistance increases, common infections become harder to treat, leading to prolonged illness, higher healthcare costs, and increased mortality.
The discovery of antibiotics marked a turning point in modern medicine, significantly reducing morbidity and mortality associated with infectious diseases. According to the World Health Organization, antibiotics have played a critical role in controlling bacterial infections and supporting complex medical procedures such as surgeries, cancer therapy, and organ transplantation (World Health Organization, 2020). However, the continued effectiveness of these medicines largely depends on their rational use across healthcare systems. Rational use involves appropriate prescribing, correct dosing, adequate duration of treatment, and responsible distribution, all of which are essential for maintaining antibiotic efficacy and public health safety.
Prestinaci, Pezzotti, and Pantosti (2015) reported that misuse and overuse of antibiotics are the primary drivers of antimicrobial resistance worldwide. As a result, bacteria are increasingly able to adapt and survive antibiotic exposure, rendering standard treatments ineffective and leading to more severe and persistent infections. In developing countries, the problem of antibiotic misuse is more pronounced due to weak regulatory structures and limited public awareness. Laxminarayan et al. (2013) asserted that poor regulation of antibiotic sales and inadequate surveillance systems significantly contribute to rising resistance levels in low- and middle-income countries. In Nigeria, antibiotics are often readily available without prescription, encouraging self-medication and inappropriate use.
The pharmaceutical industry occupies a central position in the antibiotic use chain, influencing drug production, quality assurance, marketing, and distribution. Ventola (2015) stated that pharmaceutical companies have a responsibility to promote ethical marketing practices and support antimicrobial stewardship to prevent misuse of antibiotics. Manufacturers are expected to ensure compliance with regulatory standards, provide accurate drug information, and collaborate with healthcare professionals to encourage rational prescribing. Failure to uphold these responsibilities may indirectly contribute to inappropriate antibiotic consumption and the acceleration of resistance.
In Nigeria, pharmaceutical firms such as Fidson Healthcare Plc play a significant role in ensuring access to essential antibiotics. Fidson Healthcare Plc is one of the leading indigenous pharmaceutical companies involved in the manufacturing and distribution of antibiotic products across the country. The Federal Ministry of Health (2017) affirmed that local pharmaceutical manufacturers are vital to achieving national health objectives, including medicine security and antimicrobial resistance control. However, balancing commercial interests with public health responsibilities remains a challenge for many firms operating in competitive markets.
O'Neill (2016) articulated that antimicrobial resistance is not only a medical problem but also an economic and industrial challenge that requires the active involvement of pharmaceutical companies, regulators, healthcare providers, and consumers. Without such collaboration, efforts to promote rational antibiotic use may remain fragmented and ineffective (O'Neill, 2016). Although global and national policies on antimicrobial stewardship exist, there is limited empirical research focusing on the role of individual pharmaceutical companies in promoting rational antibiotic use within the Nigerian context. This study is set against the backdrop of increasing concerns about irrational antibiotic use and the growing threat of antimicrobial resistance, with specific reference to Fidson Healthcare Plc.
1.3 Purpose of the Study
The purpose of this study is to examine the rational use of antibiotics and the factors contributing to antimicrobial resistance, with specific reference to Fidson Healthcare Plc. It aims to assess existing practices, identify gaps in compliance with regulatory standards, and provide intuitions that will improve antibiotic stewardship within the company and the broader Nigerian healthcare system.
1.4 Statement of Problems
Investigation revealed that the rational use of antibiotics is a critical requirement for effective healthcare delivery, yet inappropriate antibiotic use remains a persistent challenge within pharmaceutical production, distribution, and utilization systems. In many healthcare settings, antibiotics are frequently used without adequate diagnostic confirmation, proper dosage, or adherence to recommended treatment durations (World Health Organization, 2020).
In pharmaceutical manufacturing and distribution organizations such as Fidson Healthcare Plc, the responsibility for promoting rational antibiotic use extends beyond production to include ethical marketing practices, compliance with national and international guidelines, and collaboration with healthcare professionals.
However, concerns have been raised that market-driven pressures, aggressive promotion, and inadequate post-marketing surveillance may influence prescribing and consumption patterns in ways that encourage irrational antibiotic use (O'Neill, 2016). It is against this backdrop that this study seeks to investigate the rational use of antibiotics and the rise of resistance, with specific reference to Fidson Healthcare Plc.
1.5 Aim and Objectives of Study
The aim of the study is to evaluate the rational use of antibiotics and the rise of antimicrobial resistance, using Fidson Healthcare Plc as a case study. In achieving this aim, the following specific objectives were laid out as follows:
- To identify the factors contributing to irrational antibiotic use within the company and the wider healthcare system.
- To assess the level of adherence to rational antibiotic use guidelines by Fidson Healthcare Plc.
- To evaluate the impact of antibiotic misuse on the development of resistance in Nigeria.
- To recommend strategies for improving rational use of antibiotics and controlling resistance in the pharmaceutical sector.
1.6 Research Questions
The study came up with research questions so as to be able to ascertain the above stated objectives. The specific research questions for the study are stated below as follows:
- To what extent does Fidson Healthcare Plc adhere to rational antibiotic use guidelines?
- What are the factors contributing to irrational antibiotic use within Fidson Healthcare Plc and the Nigerian healthcare system?
- How does antibiotic misuse influence the development of resistance in Nigeria?
- What strategies can be implemented to enhance rational use of antibiotics and reduce resistance in the pharmaceutical sector?
1.7 Research Hypothesis
In order to pursue the objective of this study, the following generalized statements have been designed to guide and aids in obtaining the result for the experiment to be conducted. For this work, the null hypothesis will be represented with H0 while the alternative hypothesis will be represented with hypothesis H1.
- Null Hypothesis (H 0 ): There is no significant relationship between antibiotic use practices at Fidson Healthcare Plc and the rise of antimicrobial resistance in Nigeria.
- Alternative Hypothesis (H1): There is a significant relationship between antibiotic use practices at Fidson Healthcare Plc and the rise of antimicrobial resistance in Nigeria.
1.8 Significance of Study
It is believed that at the completion of the study, the findings will help policymakers design effective regulations to enforce rational antibiotic use. It will also enable healthcare providers to adopt best practices in prescribing and administering antibiotics.
Furthermore, the research will inform pharmaceutical companies, including Fidson Healthcare Plc, on strategies to promote responsible marketing and distribution of antibiotics. In addition, the study will educate patients and the public on the dangers of antibiotic misuse and the importance of adherence to prescribed treatments.
Lastly, the findings will support researchers and students in exploring further studies on antimicrobial resistance and pharmaceutical stewardship.
1.9 Scope of Study
The study focuses on the rational use of antibiotics and the rise of antimicrobial resistance, with Fidson Healthcare Plc in Lagos State, Nigeria, serving as the focal point.
1.10 Limitations of the Study
During the course of this study, there were some problems encountered which stood as limitations to the research work. Some of the limitations include:
- Time Constraint: The time frame given to accomplish this project was very short due to school academic calendar and it was carried out under pressure which made the researcher not to implement some necessary features.
- Financial Constraint: Insufficient fund tends to impede the efficiency of the researcher in sourcing for the relevant materials, literature or information and in the process of data collection (internet, questionnaire and interview).
- Initial Cooperation Delay from Respondents: A particular limitation of this work came as a result of the respondent refusal to offer their cooperation at the initial time they were contacted. This contributed in making the success of this research study difficult.
1.11 Definition of Terms
Antibiotics: Medicines used to prevent or treat bacterial infections by either killing or inhibiting the growth of bacteria (World Health Organization, 2020).
Rational Use of Antibiotics: The process in which antibiotics are prescribed appropriately according to the patient's condition, dosage, duration, and cost-effectiveness, ensuring optimal outcomes and minimizing resistance (WHO, 2002).
Antimicrobial Resistance: The ability of microorganisms, such as bacteria, to resist the effects of an antimicrobial agent that was previously effective against them (Prestinaci, Pezzotti, & Pantosti, 2015).
Pharmaceutical Stewardship: The responsible management and use of pharmaceutical products, including antibiotics, to promote public health and minimize misuse (Ventola, 2015).
Fidson Healthcare Plc: A leading Nigerian pharmaceutical company engaged in the manufacture, marketing, and distribution of essential medicines, including antibiotics, across Nigeria (Federal Ministry of Health, 2017).
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