| dc.description.abstract | Background: Access to medicines is a basic human right. The World Health Organization (WHO) Model List of Essential Medicines was created in 1977, to promote access to essential medicines that satisfy the priority health care needs of the population. In this day and age, access to safe and affordable medicines is not guaranteed to all. There exists global inequality of access to lifesaving or essential medicines. This is referred to by the WHO as the ‘global drug gap’, in which approximately one third of the global population still does not have access to basic medicines. Contributing to the disparity in access, are rising pharmaceutical expenditures and globalisation of complex pharmaceutical supply chain networks. This has resulted in countries of all economies and geographical regions sourcing their medicines from common sources. Therefore, challenges accessing unavailable medicines have become a shared experience, as demonstrated by the relatively recent emergence and recurrence of global drug shortage crises. The WHO framework for access to essential medicines, which considers rational selection of medicines, affordable prices, sustainable financing, and reliable health and supply systems, was used as a theoretical framework to explore the gap in access to medicines. Aims and Objectives: Aim: To explore stakeholder views about the concept of essential medicines. Objectives: (1) To explore the application of the Essential Medicines List (EML) concept and how this was associated with access to essential medicines. (2) To explore the factors that influence access to essential medicines, and understand the roles of international key stakeholders involved in this process. (3) To explore what constitutes an “essential” medicine, and how the EML concept functions in a high income country (HIC) context. Content of This Thesis This thesis is made up of 4 chapters. Chapter 1 contains the background and a review of the literature on access to essential medicines. The challenges identified in chapter 1 lead to the exploration of global perspectives on the supply and management of essential medicines in chapter 2. The qualitative study in chapter 3 describes what constitutes an essential medicine for stakeholders in a high income country (HIC). Lastly, chapter 4 contains general discussions and conclusions from the work described in this thesis. Methods: A narrative literature review (chapter 1) was performed to explore how the application of the EML concept is associated with access to essential medicines. A search strategy developed from the principles of the WHO access to medicines framework was used to identify primary studies from Medline, Embase and PubMed. A qualitative study was conducted to explore perspectives of international (chapter 2) and Australian (chapter 3) key stakeholders about the pharmaceutical supply chain, on the application and relevance of EML concept and what makes a medicine essential. Snowball sampling was used to recruit decision makers, leaders or senior managers involved in medicines decision making across seven stakeholder groups. Stakeholders included: government, health care providers, academics, consumer groups, non-profit organisations, pharmaceutical manufacturers and wholesaler/distributors. Forty-seven semi structured interviews were conducted face-to-face, via Skype or telephone, audio-recorded and transcribed verbatim. Interviews were conducted until thematic saturation was achieved. Data were analysed using a grounded theory approach. The comprehensive theory of collaboration was applied after the grounded theory analysis to organise and understand results within a management context. In addition, chapter 2 used the Ishikawa fishbone diagram to illustrate the complexities of the pharmaceutical supply chain. Meanwhile, chapter 3 illustrated the conceptual model derived from the results. Key Findings: Chapter 1- A literature review showed that there has been improved access to essential medicines for many populations. Findings showed EMLs help promote advocacy and provide reliable evidence at the health systems level. However, there was variable use of EMLs at the health services delivery level (i.e. for a patient at the point of care). Decision making around standard treatment guidelines and EMLs were often not aligned with procurement and management strategies within the supply chain. The literature review showed that accessing medicines was complex. Studies were often not well-designed, had narrow research objectives and few qualitative studies were conducted. Studies focused on resource limited settings in LMICs and scarce data was available for EMLs in HICs. Chapter 2- Qualitative interviews with international stakeholders described the complexities involved in managing the global pharmaceutical supply chain. While stakeholders’ roles and responsibilities were inter-connected, therapeutic decision making was often separated from logistic management of the pharmaceutical supply chain due to potential conflicts of interest. This created many gaps and inconsistencies around pricing and costs, planning and reactivity, communication and transparency, and contributed to difficulties building trust and consistency between stakeholders. Adding to this complexity, individualised or patient-centred care approaches have emphasised the need for consumer choice and demand a wide range of products that has become increasingly challenging to manage. Therefore, drug shortages have highlighted the opportunity for collaborative alliances to identify, prioritise, and manage vulnerabilities in the supply chain to prevent or mitigate patient harm as a result of restricted access to medicines. In particular, wholesalers and distributors were identified as potentially having more valuable roles in managing supply disruptions (e.g. redistribution) and facilitating information exchange between stakeholders (e.g. forecasting or confirming at what level of the system a shortage occurs). Participants also suggested designating drug shortage experts or liaison to manage and communicate shortages, especially to consumers and health providers. Chapter 3- Qualitative interviews with Australian stakeholders demonstrated that the different perceived functions of EMLs seemed to be stratified depending on whether the decision making context was at a health systems level or at an individual level (i.e., for a patient at the point of care). EMLs can function as reimbursement lists at the health systems level, or hospital formularies at the health services level. Meanwhile, non-reimbursed or off-formulary medicines were available to consumers who were willing and able to pay if they were deemed essential to individuals. Conversely, some medicines can be deemed essential but were not available or affordable to individuals. The wide range of views in this study, highlight the complexities of decision-making processes involved in developing and managing EMLs, which has been compounded by the expanding consumer need to have a range of therapeutic options. These findings emphasise the context within the health system determines for whom a medicine is deemed essential. Conclusion: Prior to this thesis, EMLs have been studied with narrow research objectives and mainly in LMICs. This body of research was the first to explore how the application and management of EMLs effected access to medicines, from a broad range of stakeholder views involved in both therapeutic decision making and logistics management. Furthermore, it was also a rare study that examined the EML concept within HIC contexts. Findings from this body of work demonstrated different perceived functions of the EML. Furthermore, it also questioned whether the term ‘essential’ was appropriate and reflected how the EML was used. While EMLs can be useful to guide evidence based decision making for reimbursement at the systems level, the variations in the notion of essential at the individual level is influenced by an individual’s choice. Therefore, this highlights the importance of guiding (or limiting) consumer choice with appropriate and accessible information, to help individuals make informed and responsible decisions. This research confirmed that the access to medicines gap continues to be problematic. The pharmaceutical supply chain has been unable to handle drug shortages adequately. Therefore, in order to sustain patient-centred care practices, concessions by all stakeholders must be made if the supply chain is to withstand global economic, political, and ecological instability. Multi-stakeholder engagement, transparent processes, innovative communication pathways, and EML approaches offer potential solutions to mitigate supply chain disruptions. Future approaches should align decision making priorities with procurement practices. Decision makers and supply chain managers have a valuable opportunity to reflect and understand how the current system is functioning, in order to develop foundations for improved processes, and innovative and cooperative platforms to interact and network. | en_AU |
