The Journey from Lean Manufacturing to Industry 4.0: The Rail Manufacturing Process in Mexico

Nowadays, Lean Manufacturing and Industry 4.0 are very important in every country. One of the main benefits is continued market presence. It has been identified that there is a need to change existing educational programs, as well as update the knowledge and skills of existing employees. It should be borne in mind that behind each technological improvement, there is a human being. Human talent cannot be neglected. The main objectives of this article are to review the link between Lean Manufacturing, the incorporation of Industry 4.0 and the steps to follow to implement it; analyze the current situation and study the implications and benefits of this new trend, with a particular focus on Mexico. Lean Manufacturing and Industry 4.0 implementation waves must always take care of the most important capital – intellectual capital. The methodology used in this article comprised the following steps: reviewing the reality of the fourth industrial revolution, reviewing employees’ skills on the journey to become world-class, and analyzing the situation in Mexico. Lean Manufacturing and Industry 4.0 were studied not as exclusive concepts, but as complementary ones. The methodological framework used is focused on motivating companies’ collaborators to guarantee common results, innovate, and remain in the market in the face of new requirements from company stakeholders. The key findings were that both trends emphasize the need to improve communication across the entire company and incorporate new technologies into everyday work, from the shop floor to administrative staff, to help improve processes. Taking care of people, activities and processes will bring a company success. In the specific case of Mexico, companies in all sectors need to be aware of and implement technological improvements according to their specific needs. Low-cost labor represents one of the most typical barriers. In conclusion, companies must build a roadmap according to their strategy and needs to achieve their short, medium- and long-term goals.

Challenges and Opportunities of E-Procurement in the Construction Industry

Construction Industry is evolving amid the fourth industrial revolution. Transportation, commerce, manufacturing and many other industries ripened the current technological advancement and are striving to utilise every development in the IT sector. The procurement of construction works is known to be very conventional and backward in the adoption of digitalisation. The construction industry's procurement and supply chain are blamed for the most inflated cost of construction projects, mainly attributed to a lack of transparency and trust between the industry stakeholders. This research explores the challenges of e-procurement adoption in the industry and identifies the potential opportunities for its usage. This investigation's data are acquired through interviews, and the data are analysed using qualitative content analysis. This study reveals compounding challenges (i.e., corruption and lack of commitment) that lead to the failure of such efforts in Nigeria and the potential prospects (i.e., transparency and efficiency). This study is essential in developing a more effective and transparent process of procurement so that the Nigerian construction industry is not be left behind in the fast-digitalising markets.

Using Blockchain Technology to Extend the Vendor Managed Inventory for Sustainability

Nowadays, Information Technology (IT) is changing the way traditional enterprise management concepts work. One of the most dominant IT achievements is the Blockchain Technology. This technology enables the distributed collaboration of stakeholders for their interactions while fulfilling the security and consensus rules among them. This paper has focused on the application of Blockchain technology to enhance one of traditional inventory management models. The Vendor Managed Inventory (VMI) has been considered one of the most efficient mechanisms for vendor inventory planning by the suppliers. While VMI has brought competitive advantages for many industries, however its centralized mechanism limits the collaboration of a pool of suppliers and vendors simultaneously. This paper has studied the recent research for VMI application in industries and also has investigated the applications of Blockchain technology for decentralized collaboration of stakeholders. Focusing on sustainability issue for total supply chain consisting suppliers and vendors, it has proposed a Blockchain based VMI conceptual model. The different capabilities of this model for enabling the collaboration of stakeholders while maintaining the competitive advantages and sustainability issues have been discussed.

Development of an Intelligent Decision Support System for Smart Viticulture

The Internet of Things (IoT) represents the best option for smart vineyard applications, even if it is necessary to integrate the technologies required for the development. This article is based on the research and the results obtained in the DISAVIT project. For Smart Agriculture, the project aims to provide a trustworthy, intelligent, integrated vineyard management solution that is based on the IoT. To have interoperability through the use of a multiprotocol technology (being the future connected wireless IoT) it is necessary to adopt an agnostic approach, providing a reliable environment to address cyber security, IoT-based threats and traceability through blockchain-based design, but also creating a concept for long-term implementations (modular, scalable). The ones described above represent the main innovative technical aspects of this project. The DISAVIT project studies and promotes the incorporation of better management tools based on objective data-based decisions, which are necessary for agriculture adapted and more resistant to climate change. It also exploits the opportunities generated by the digital services market for smart agriculture management stakeholders. The project's final result aims to improve decision-making, performance, and viticulturally infrastructure and increase real-time data accuracy and interoperability. Innovative aspects such as end-to-end solutions, adaptability, scalability, security and traceability, place our product in a favorable situation over competitors. None of the solutions in the market meet every one of these requirements by a unique product being innovative.

The Relations among Business Model, Higher Education, University and Entrepreneurship Education: An Analysis of Academic Literature of 2009-2019 Period

Business model (BM) is a term that has been receiving the attention of scholars and practitioners and has been consolidating itself as a field of study and research. Although there is no agreement in the academic literature on the definition of BM, at least there is an explicit agreement: BM defines a logical structure of how an organization creates value, capture value and delivers value for the customers and stakeholders. The lack of understanding about connections and elements among BM and higher education, university, and entrepreneurship education opens a gap in the academic literature. Thus, it is interesting to analyze how BM has been approached by the literature and applied in higher education, university, and entrepreneurship education aimed to know the main streams of research. This is because higher education institutions are characterized by innovation, leading to a greater acceptance of new and modern concepts such as BM. Our research has the main motivation to fill the gap in the academic literature, making it possible to increase the power of understanding about connections and aspects among BM and higher education, university, and entrepreneurship education. The objective of the research is to analyze the main aspects among BM and higher education, university, and entrepreneurship education in academic literature. The research followed the systematic literature review (SLR). The SLR is based on three main factors: clarity, validity, and auditability. 82 academic papers were found in the past 10 years, from 2009-2019. The search was carried out in Science Direct and Periodicos Capes databases. The main findings indicate that there are links between BM and higher education, BM and university, BM, and entrepreneurship education. The main findings are inserted within seven aspects. The findings are innovative and contribute to increase the power of understanding about the connection among BM and higher education, university, and entrepreneurship education in academic literature. The research findings addressed to the gap exposed in academic literature. The research findings have several practical implications, and we highlight only two main ones. First, researchers will be able to use the research findings to mitigate a BM research agenda involving connections between BM and higher education, BM and university, and BM and entrepreneurship education. Second, directors, deans, and university leaders will be able to carry out BM awareness programs, BM professors training programs, and makers planning for the inclusion of BM, as one of the components of the curricula of the undergraduate and graduate courses.

Agritourism Potentials in Oman: An Overview with Visionary for Adoption

Most Gulf Cooperation Council (GCC) countries with oil-based economy like Oman are looking for other potential revenue generation options as the crude oil price is regularly fluctuating due to changing geopolitical environment. Oman has advantage of possessing world-heritage nature tourism hotspots around the country and the government is making investments and strategies to uplift the tourism industry following Oman Vision 2040 strategies. Oman’s agriculture is not significantly contributing to the economy, but possesses specific and diversified arid cropping systems. Oman has modern farms; nevertheless some of the agricultural production activities are done with cultural practices and styles that would be attractive to tourists. The aim of this paper is to investigate the potentials for promoting agritourism industry in Oman; recognize potential sites, commodities and activities, and predict potential revenue generation as a projection from that of the tourism sector. Moreover, the study enables to foresee possible auxiliary advantages of agritourism such as, empowerment of women and youth, enhancement in the value-addition industry for agricultural produce through technology transfer and capacity building, and producing export quality products. Agritourism could increase employability, empowerment of women and youth, improve value-addition industry and export-oriented agribusiness. These efforts including provision of necessary technology-transfer and capacity-building should be rendered by the collaboration of academic institutions, relevant ministries and other public and private sector stakeholders.

Design and Māori Values: A Rebrand Project for the Social Enterprise Sector

This paper details a rebrand design project developed for a non-profitable organization called Te Roopu Waiora (TRW), which is currently located in Auckland, Aotearoa New Zealand. This social enterprise is dedicated to supporting the Māori community living with sensorial, physical and intellectual disabilities (whānau hauā). As part of a year three bachelor design brief, the rebrand project enabled students to reflect on Kaupapa Māori principles and appropriately address the values of the organisation. As such, the methodology used a pragmatic paradigm approach and mixed methods design practices involving a human-centred design to problem solving. As result, the student project culminated in the development in a range of cohesive design artefacts, aiming to improve the rentability and perception of the brand with the audience and stakeholders.

The Attitude towards Sustainable Development Issues among Malaysian Engineering Undergraduates

This paper reports the findings of the perception and attitude towards Sustainable Development among Malaysian undergraduates. The study was carried out involving 86 engineering undergraduates from three universities in Malaysia. This research was conducted based on a survey whereby the respondents were given a questionnaire to gauge their attitude towards sustainable development. The output of the analyses showed that the respondents have an appropriate attitude towards the sustainability issues expect for economic and social equality aspects. These findings suggest that the engineering educators involved in sustainable development education need to educate undergraduate students on this important issue. This investigation serves as a cornerstone to which the current paradigm of sustainable development education can be examined for further improvement by related stakeholders.

Intellectual Capital Disclosure: Profiles of Spanish Public Universities

In the higher education setting, there is a current trend in society toward greater openness and transparency. The economic, social and political changes that have occurred in recent years in public sector universities (particularly the New Public Management, the Bologna Process and the emergence of the “third mission”) call for a wider disclosure of value created by universities to support fundraising activities, to ensure accountability in the use of public funds and the outcomes of research and teaching, as well as close relationships with industries and territories. The paper has two purposes: 1) to explore the intellectual capital (IC) disclosure in Spanish universities through their websites, and 2) to identify university profiles. This study applies a content analysis to analyze the institutional websites of Spanish public universities and a cluster analysis. The analysis reveals that Spanish universities’ website content usually relates to human capital, while structural and relational capitals are less widely disclosed. Our research identifies three behavioral profiles of Spanish universities with regard to the online disclosure of IC (universities more proactive, universities less proactive and universities adopt a middle position in this regard. The results can serve as encouragement to university managers to enhance online IC disclosure to meet the information needs of university stakeholders.

The South African Polycentric Water Resource Governance-Management Nexus: Parlaying an Institutional Agent and Structured Social Engagement

South Africa, a water scarce country, experiences the phenomenon that its life supporting natural water resources is seriously threatened by the users that are totally dependent on it. South Africa is globally applauded to have of the best and most progressive water laws and policies. There are however growing concerns regarding natural water resource quality deterioration and a critical void in the management of natural resources and compliance to policies due to increasing institutional uncertainties and failures. These are in accordance with concerns of many South African researchers and practitioners that call for a change in paradigm from talk to practice and a more constructive, practical approach to governance challenges in the management of water resources. A qualitative theory-building case study through longitudinal action research was conducted from 2014 to 2017. The research assessed whether a strategic positioned institutional agent can be parlayed to facilitate and execute WRM on catchment level by engaging multiple stakeholders in a polycentric setting. Through a critical realist approach a distinction was made between ex ante self-deterministic human behaviour in the realist realm, and ex post governance-management in the constructivist realm. A congruence analysis, including Toulmin’s method of argumentation analysis, was utilised. The study evaluated the unique case of a self-steering local water management institution, the Impala Water Users Association (WUA) in the Pongola River catchment in the northern part of the KwaZulu-Natal Province of South Africa. Exploiting prevailing water resource threats, it expanded its ancillary functions from 20,000 to 300,000 ha. Embarking on WRM activities, it addressed natural water system quality assessments, social awareness, knowledge support, and threats, such as: soil erosion, waste and effluent into water systems, coal mining, and water security dimensions; through structured engagement with 21 different catchment stakeholders. By implementing a proposed polycentric governance-management model on a catchment scale, the WUA achieved to fill the void. It developed a foundation and capacity to protect the resilience of the natural environment that is critical for freshwater resources to ensure long-term water security of the Pongola River basin. Further work is recommended on appropriate statutory delegations, mechanisms of sustainable funding, sufficient penetration of knowledge to local levels to catalyse behaviour change, incentivised support from professionals, back-to-back expansion of WUAs to alleviate scale and cost burdens, and the creation of catchment data monitoring and compilation centres.

Branding Good Corporate Governance: A Pathway to Strengthen Investors’ Perception and Brand Equity

Corporate governance has become a crucial issue in both the business and academic world as a result of world-wide financial scandals and lack of trust in corporate practices. There is no doubt that in order to thrive and attain growth in the market, a company must earn the trust of its stakeholders by consistently delivering on its commitments. Directors of the companies thus comprehend the importance of upfront communication with relevant stakeholders to increase their confidence. The authors of this article argue that practicing good corporate governance is not enough in this highly competitive market place; corporate leaders need to market their good corporate governance practices in order to make the company more attractive to investors. This article also contends that the strength of corporate governance relies wholly upon the extent to which it is communicated simply, effectively and unceasingly to its stakeholders. The main objective of this study, therefore, is to explore the importance of branding good corporate governance in order to increase corporate brand equity, attract investors, and capture market share. A structured questionnaire comprising three sections and a total of 34 questions was prepared and surveyed by the authors among respondents residing in Bangladesh and who also have an academic and corporate background, to investigate the potential impact of branding good corporate governance in the market place. High mean values for individual questions and overall section depict that communicating and branding good corporate governance to the stakeholders will not only boost the investors’ confidence but also increase the corporate brand equity, yielding both profitable and sustainable business environment.

Quantifying Uncertainties in an Archetype-Based Building Stock Energy Model by Use of Individual Building Models

Focus on reducing energy consumption in existing buildings at large scale, e.g. in cities or countries, has been increasing in recent years. In order to reduce energy consumption in existing buildings, political incentive schemes are put in place and large scale investments are made by utility companies. Prioritising these investments requires a comprehensive overview of the energy consumption in the existing building stock, as well as potential energy-savings. However, a building stock comprises thousands of buildings with different characteristics making it difficult to model energy consumption accurately. Moreover, the complexity of the building stock makes it difficult to convey model results to policymakers and other stakeholders. In order to manage the complexity of the building stock, building archetypes are often employed in building stock energy models (BSEMs). Building archetypes are formed by segmenting the building stock according to specific characteristics. Segmenting the building stock according to building type and building age is common, among other things because this information is often easily available. This segmentation makes it easy to convey results to non-experts. However, using a single archetypical building to represent all buildings in a segment of the building stock is associated with loss of detail. Thermal characteristics are aggregated while other characteristics, which could affect the energy efficiency of a building, are disregarded. Thus, using a simplified representation of the building stock could come at the expense of the accuracy of the model. The present study evaluates the accuracy of a conventional archetype-based BSEM that segments the building stock according to building type- and age. The accuracy is evaluated in terms of the archetypes’ ability to accurately emulate the average energy demands of the corresponding buildings they were meant to represent. This is done for the buildings’ energy demands as a whole as well as for relevant sub-demands. Both are evaluated in relation to the type- and the age of the building. This should provide researchers, who use archetypes in BSEMs, with an indication of the expected accuracy of the conventional archetype model, as well as the accuracy lost in specific parts of the calculation, due to use of the archetype method.

Conventional and Islamic Perspective in Accounting: Potential for Alternative Reporting Framework

This paper provides an overview of fundamental philosophical and functional differences in conventional and Islamic accounting. The aim of this research is to undertake a detailed analysis focus on specific illustrations drawn from both these systems and highlight how these differences implicate in recording financial transactions and preparation of financial reports for a range of stakeholders. Accounting as being universally considered as a platform for providing a ‘true and fair’ view of corporate entities can be challenged in the current world view, as the business environment has evolved and transformed significantly. Growth of the non-traditional corporate entity such as Islamic financial institutions, fundamentally questions the applicability of conventional accounting standards in preparation of Shariah-compliant financial reporting. Coupled with this, there are significant concerns about the wider applicability of Islamic accounting standards and framework in order to achieve reporting practices satisfying the information needs generally. Against the backdrop of such a context, this paper raises fundamental question as to how potential convergence could be achieved between these two systems in order to provide users’ a transparent and comparable state of financial information resulting in an alternative framework of financial reporting.

Building the Professional Readiness of Graduates from Day One: An Empirical Approach to Curriculum Continuous Improvement

Industry employers require new graduates to bring with them a range of knowledge, skills and abilities which mean these new employees can immediately make valuable work contributions. These will be a combination of discipline and professional knowledge, skills and abilities which give graduates the technical capabilities to solve practical problems whilst interacting with a range of stakeholders. Underpinning the development of these disciplines and professional knowledge, skills and abilities, are “enabling” knowledge, skills and abilities which assist students to engage in learning. These are academic and learning skills which are essential to common starting points for both the learning process of students entering the course as well as forming the foundation for the fully developed graduate knowledge, skills and abilities. This paper reports on a project created to introduce and strengthen these enabling skills into the first semester of a Bachelor of Information Technology degree in an Australian polytechnic. The project uses an action research approach in the context of ongoing continuous improvement for the course to enhance the overall learning experience, learning sequencing, graduate outcomes, and most importantly, in the first semester, student engagement and retention. The focus of this is implementing the new curriculum in first semester subjects of the course with the aim of developing the “enabling” learning skills, such as literacy, research and numeracy based knowledge, skills and abilities (KSAs). The approach used for the introduction and embedding of these KSAs, (as both enablers of learning and to underpin graduate attribute development), is presented. Building on previous publications which reported different aspects of this longitudinal study, this paper recaps on the rationale for the curriculum redevelopment and then presents the quantitative findings of entering students’ reading literacy and numeracy knowledge and skills degree as well as their perceived research ability. The paper presents the methodology and findings for this stage of the research. Overall, the cohort exhibits mixed KSA levels in these areas, with a relatively low aggregated score. In addition, the paper describes the considerations for adjusting the design and delivery of the new subjects with a targeted learning experience, in response to the feedback gained through continuous monitoring. Such a strategy is aimed at accommodating the changing learning needs of the students and serves to support them towards achieving the enabling learning goals starting from day one of their higher education studies.

Assessment of the Situation and the Cause of Junk Food Consumption in Iranians: A Qualitative Study

The consumption of junk food in Iran is alarmingly increasing. This study aimed to investigate the influencing factors of junk food consumption and amendable interventions that are criticized and approved by stakeholders, in order to presented to health policy makers. The articles and documents related to the content of study were collected by using the appropriate key words such as junk food, carbonated beverage, chocolate, candy, sweets, industrial fruit juices, potato chips, French fries, puffed corn, cakes, biscuits, sandwiches, prepared foods and popsicles, ice cream, bar, chewing gum, pastilles and snack, in scholar.google.com, pubmed.com, eric.ed.gov, cochrane.org, magiran.com, medlib.ir, irandoc.ac.ir, who.int, iranmedex.com, sid.ir, pubmed.org and sciencedirect.com databases. The main key points were extracted and included in a checklist and qualitatively analyzed. Then a summarized abstract was prepared in a format of a questionnaire to be presented to stakeholders. The design of this was qualitative (Delphi). According to this method, a questionnaire was prepared based on reviewing the articles and documents and it was emailed to stakeholders, who were asked to prioritize and choose the main problems and effective interventions. After three rounds, consensus was obtained.            Studies revealed high consumption of junk foods in the Iranian population, especially in children and adolescents. The most important affecting factors include availability, low price, media advertisements, preference of fast foods taste, the variety of the packages and their attractiveness, low awareness and changing in lifestyle. Main interventions recommended by stakeholders include developing a protective environment, educational interventions, increasing healthy food access and controlling media advertisements and putting pressure from the Industry and Mining Ministry on producers to produce healthy snacks. According to the findings, the results of this study may be proposed to public health policymakers as an advocacy paper and to be integrated in the interventional programs of Health and Education ministries and the media. Also, implementation of supportive meetings with the producers of alternative healthy products is suggested.

Building Information Modelling for Construction Delay Management

The Kingdom of Saudi Arabia (KSA) is not an exception in relying on the growth of its construction industry to support rapid population growth. However, its need for infrastructure development is constrained by low productivity levels and cost overruns caused by factors such as delays to project completion. Delays in delivering a construction project are a global issue and while theories such as Optimism Bias have been used to explain such delays, in KSA, client-related causes of delays are also significant. The objective of this paper is to develop a framework-based approach to explore how the country’s construction industry can manage and reduce delays in construction projects through building information modelling (BIM) in order to mitigate the cost consequences of such delays.  It comprehensively and systematically reviewed the global literature on the subject and identified gaps, critical delay factors and the specific benefits that BIM can deliver for the delay management.  A case study comprising of nine hospital projects that have experienced delay and cost overruns was also carried out. Five critical delay factors related to the clients were identified as candidates that can be mitigated through BIM’s benefits. These factors are: Ineffective planning and scheduling of the project; changes during construction by the client; delay in progress payment; slowness in decision making by the client; and poor communication between clients and other stakeholders. In addition, data from the case study projects strongly suggest that optimism bias is present in many of the hospital projects. Further validation via key stakeholder interviews and documentations are planned.

Inner and Outer School Contextual Factors Associated with Poor Performance of Grade 12 Students: A Case Study of an Underperforming High School in Mpumalanga, South Africa

Often a Grade 12 certificate is perceived as a passport to tertiary education and the minimum requirement to enter the world of work. In spite of its importance, many students do not make this milestone in South Africa. It is important to find out why so many students still fail in spite of transformation in the education system in the post-apartheid era. Given the complexity of education and its context, this study adopted a case study design to examine one historically underperforming high school in Bushbuckridge, Mpumalanga Province, South Africa in 2013. The aim was to gain a understanding of the inner and outer school contextual factors associated with the high failure rate among Grade 12 students.  Government documents and reports were consulted to identify factors in the district and the village surrounding the school and a student survey was conducted to identify school, home and student factors. The randomly-sampled half of the population of Grade 12 students (53) participated in the survey and quantitative data are analyzed using descriptive statistical methods. The findings showed that a host of factors is at play. The school is located in a village within a municipality which has been one of the poorest three municipalities in South Africa and the lowest Grade 12 pass rate in the Mpumalanga province.   Moreover, over half of the families of the students are single parents, 43% are unemployed and the majority has a low level of education. In addition, most families (83%) do not have basic study materials such as a dictionary, books, tables, and chairs. A significant number of students (70%) are over-aged (+19 years old); close to half of them (49%) are grade repeaters. The school itself lacks essential resources, namely computers, science laboratories, library, and enough furniture and textbooks. Moreover, teaching and learning are negatively affected by the teachers’ occasional absenteeism, inadequate lesson preparation, and poor communication skills. Overall, the continuous low performance of students in this school mirrors the vicious circle of multiple negative conditions present within and outside of the school. The complexity of factors associated with the underperformance of Grade 12 students in this school calls for a multi-dimensional intervention from government and stakeholders. One important intervention should be the placement of over-aged students and grade-repeaters in suitable educational institutions for the benefit of other students.

Electric Vehicle Market Penetration Impact on Greenhouse Gas Emissions for Policy-Making: A Case Study of United Arab Emirates

The United Arab Emirates is clearly facing a multitude of challenges in curbing its greenhouse gas emissions to meet its pre-allotted framework of Kyoto protocol and COP21 targets due to its hunger for modernization, industrialization, infrastructure growth, soaring population and oil and gas activity. In this work, we focus on the bonafide zero emission electric vehicles market penetration in the country’s transport industry for emission reduction. We study the global electric vehicle market trends, the complementary battery technologies and the trends by manufacturers, emission standards across borders and prioritized advancements which will ultimately dictate the terms of future conditions for the United Arab Emirate transport industry. Based on our findings and analysis at every stage of current viability and state-of-transport-affairs, we postulate policy recommendations to local governmental entities from a supply and demand perspective covering aspects of technology, infrastructure requirements, change in power dynamics, end user incentives program, market regulators behavior and communications amongst key stakeholders. 

A Comparative Analysis of Solid Waste Treatment Technologies on Cost and Environmental Basis

Waste management decision making in developing countries has moved towards being more pragmatic, transparent, sustainable and comprehensive. Turkey is required to make its waste related legislation compatible with European Legislation as it is a candidate country of the European Union. Improper Turkish practices such as open burning and open dumping practices must be abandoned urgently, and robust waste management systems have to be structured. The determination of an optimum waste management system in any region requires a comprehensive analysis in which many criteria are taken into account by stakeholders. In conducting this sort of analysis, there are two main criteria which are evaluated by waste management analysts; economic viability and environmentally friendliness. From an analytical point of view, a central characteristic of sustainable development is an economic-ecological integration. It is predicted that building a robust waste management system will need significant effort and cooperation between the stakeholders in developing countries such as Turkey. In this regard, this study aims to provide data regarding the cost and environmental burdens of waste treatment technologies such as an incinerator, an autoclave (with different capacities), a hydroclave and a microwave coupled with updated information on calculation methods, and a framework for comparing any proposed scenario performances on a cost and environmental basis.

Adverse Drug Reactions Monitoring in the Northern Region of Zambia

The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.