Yes / Background: The efficacy of medicines depends on their accessibility and availability. Dedicated medicine shortage reporting systems (MSRS) have been set up in different countries, either mandatory or voluntary, following the recommendations of the World Health Organisation to ensure these. Objectives: To explore how the Medicine Shortages Reporting System (MSRS) can tackle medicine shortages through improved access and sustainability. Methods: Personnel directly involved in the reporting mechanisms for medicine shortages in eight (8) countries participated in semi-structured interviews. An interview protocol based on the Dynamic Capabilities View and Organisational Information Processing Theory (OIPT) was developed. It contained questions related to participant's views on the process involved in MSRS and how it was used to tackle shortages. Data were thematically analysed. Results: Three core elements were identified to influence MSRS's ability to tackle shortages and ensure sustainability; (1) the ability to identify what information requirements the reporting system needs, (2) identify information processing capabilities, and (3) the ability to match requirements and information processing capabilities through a dynamic capability decision-making process. The dynamic decision-making process involves reiteratively sensing shortages by understanding and validating information received. Conclusion: Building MSRS to tackle shortages for accessibility and sustainability is a systemic process that entails understanding the various elements and processes of MSRS. It includes defining medicine shortages, reconfiguring resources, defining accessibility and ensuring the system's sustainability. Our study provides insights into MSRS developed for mitigating medicine shortages and provides a framework for a sustainable MSRS. The findings extend the literature on medicine shortage management by identifying the various elements required to set up an MSRS. It also provides practical implications for countries that seek to establish MSRS to mitigate medicine shortages. Further studies could extend the number of participating countries to provide a clearer picture of the MSRS and how it can reduce medicine shortages. / This research is supported by the National Institute for Health and Care Research (NIHR) Yorkshire and Humber Patient Safety Research Collaboration (NIHR Yorkshire and Humber PSRC). Grant number - NIHR204293.

Background: In a globalised world and increased interconnected business environments effective resilience capabilities are pivotal for disruption mitigation. In the pharmaceutical industry this concerns the phenomenon of medicine shortages and high geographical sourcing dependencies resulting in severe consequences for healthcare providers and patients. Purpose: Analysing challenges affecting resilience in the upstream of the pharmaceutical supply chain network and root-causes of the heparin sourcing shortage. This study aims to find resilience strategies to effectively manage future heparin sourcing shortages. Method: This qualitative case study analysed the dynamic phenomenon of supply chain network resilience in a German listed healthcare company. Semi- structured interviews were conducted based on non-probability purposive sampling. The empirical findings were analysed according to the thematic analysis. Conclusion: The findings indicate that insufficient management of challenges impacting the supply chain network resilience leads to medicine shortages. Driven by the ethical obligation the pharmaceutical supply chain network particularly has to deal with external hurdles and sourcing dependencies created by complex product characteristics.

In the first 3 years of the Obama Administration, 2009-2011, the number of warning letters issued to pharmaceutical firms for manufacturing and quality issues increased by 81% to 49 letters. Only 9 letters were issued in the last 3 years of the George W. Bush Administration. Shortfalls in compliance and product quality led to medicine shortages that affected patients' treatment and health. This quantitative study sought to learn to what extent, if any, the independent variables, management behaviors and financial indicators at pharmaceutical firms in the United States, correlated with, or predicted, the dependent variable, compliance with the FDA regulations. FDA's enforcement actions on the firms were the treatment event. A shift in the relationship between the variables occurred after the FDA interventions, which highlighted a new level of compliance. Of the 1144 SurveyMonkey invitations sent to the members of the International Society of Pharmaceutical Engineers, only 21 completed the survey's 133 questions. Three research questions were addressed using correlations and linear regressions. The theory of planned behavior was applied to correlate behavioral constructs with the compliance of the firms leading to the rejection of the null hypothesis. By establishing an inverse relation between financial indicators and the firms' level of compliance, the study offers awareness and insight to senior leaders regarding their behaviors and the decision-making process. Enhancing managers' decision-making processes in light of their beliefs, along with their control over financial indicators, could reinforce the presence of effective quality systems among pharmaceutical manufacturers minimizing medicine shortages.