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The study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.

The article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.

The results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.

In this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.

A key feature of human rights in health is access to safe, effective and affordable medicines. Pharmacovigilance is advocated for monitoring intended/unintended effects of medicines to assure their safety. The purpose of this paper is to synthesize knowledge about supply chain impediments to safe medicines in developing nations and contribute to future development of research in this field.

This paper conducts a structured literature review based on Preferred Reporting Items for the Systematic Reviews and Meta-Analyses guidelines. It aims at profiling supply chain impediments to safe medicines in developing nations by reviewing 46 recent pharmacovigilance-specific papers published between 2005 and 2020.

Analysis of reviewed articles identified criticality of supply chain impediments that affect constituents across pharmaceutical in developing nations, which still struggle to maintain robust national pharmacovigilance systems due to lack of awareness, policy and practices.

Research results can be applied by pharmaceutical industry decision-makers and drug safety professionals in developing nations. Because the review is qualitative in nature, its implication ought to be tested after actual implementation.

This review can help identify underinvestigated impediments and methods to aid in developing new pharmacovigilance knowledge areas in developing nation context.

The review uncovers gaps in global health equity dialogue in developing nations. It also recognizes that macrolevel supply chain impediments exist due to unfair disease burden and health inequities in developing nations.

The paper examines supply chain impediments to safe medicines in developing nations with insights for future pharmacovigilance research. Identifying and classifying supply chain impediments through this review is the first step toward creating effective interventions for these impediments to safe medicines.

Cryptomarkets or darknet marketplaces host multiple ‘vendors’ selling a variety of illicit products. The most sold and sought products on such markets are illegal drugs. These markets use cryptocurrencies as a payment system and provide participants with anonymity through their location on the dark web, and in recent years they have seen continuous growth in revenue and exchange. Existing literature has provided various explanations for this growth, but in 2017 the European Monitoring Centre for Drugs and Drug Addiction and Europol concluded in their 2017 ‘Drugs and the Darknet’ report that current interpretations of trends are not sufficient. This chapter will provide an alternative explanation for this phenomenon by considering web-based drug selling and purchasing in terms of trends towards ‘Uberisation’ and ‘McDonaldisation’ and applying Bourdieu’s concept of cultural capital to the discussion of the dynamic cultures of consumption and different subcultures of the drug world.

The purpose of the present work is to improve the industry performance by identifying and quantifying the risks faced by the Indian pharmaceutical industry (IPI). The risk values for the prominent risks and overall industry are determined based on the four risk parameters, which would help determine the most contributive risks for mitigation.

An extensive literature survey was done to identify the risks, which were also validated by industry experts. The finalized risks were then evaluated using the fuzzy synthetic evaluation (FSE) method, which is the most suitable approach for the risk assessment with parameters having a set of different risk levels.

The three most contributive sub-risks are counterfeit drugs, demand fluctuations and loss of customers due to partners' poor service performance, while the main risks obtained are demand, financial and logistics. Also, the overall risk value indicates that the industry faces medium to high risk.

The study identifies the critical risks which need to be mitigated for an efficient industry. The industry is most vulnerable to the demand risk category. Therefore, the managers should minimize this risk by mitigating its sub-risks, like demand fluctuations, bullwhip effect, etc. Another critical sub-risk, the counterfeit risk, should be managed by adopting advanced technologies like blockchain, artificial intelligence, etc.

There is insufficient literature focusing on risk quantification. Therefore, this work addresses this gap and obtains the industry's most critical risks. It also discusses suitable mitigation strategies for better industry performance.

The online sourcing, supply, and purchase of illicit drugs is fast transforming drug markets worldwide. Although the long-term development of simple communications technology over time (from pagers to mobile phones) continues to impact and extend local drug supply dynamics, it is the recent developments of dark web cryptomarkets, social media applications (like Instagram), encrypted messaging applications (like WhatsApp), and surface web platforms, such as LeafedOut, that are changing the drug supply landscape online. The use of technology in drug supply has tended to go hand in hand with improving the efficiency of supply and opportunities to reduce exchange-related risks for both buyers and sellers. In relation to app-mediated supply, for example, the use of encrypted messaging provides enhanced security for arranging purchases beyond the lurking surveillance of law enforcement. Despite the perception of improved safety, however, the use of social media apps and other online platforms can expose both buyers and sellers to risk scenarios they may not fully appreciate. Drawing on two recent studies on the use of social media apps and the online platform LeafedOut as mediators of drugs supply, this chapter will consider how these mid-range (between cryptomarkets and traditional telecommunications such as basic texting/calling and material ‘street’ markets) virtual spaces are being utilised for drug supply and the extent to which this is ‘just more of the same’ or provides new structures and experiences for those engaging with it and in what ways. Consideration will also be given to contradictions in the mid-range market space where the broad perception of reduced risk from the use of encrypted messaging can in fact produce greater levels of risk for some buyers and sellers depending on how they engage with the process/es.

Increased outsourcing and importation of drugs from different parts of the world to the Latin America and the Caribbean (LAC) region result in the proliferation of substandard and fake medicines, posing a threat to public health. The presence of substandard and fake medications in LAC regions is a source of public health concern and causes an economic burden to the governments in these regions. Whereas testing and detecting medication quality can easily be achieved in developed countries, the situation is different in developing countries such as LAC. This paper aims to examine the public health challenges faced by LAC regarding substandard, fake and counterfeit medicines and how the region can tackle these challenges.

Databases such as Scopus, PubMed, ScienceDirect, Embase, HINARI, EBSCOhost, Google Scholar, unpublished data, conference abstracts and papers from World Health Organization, Pan-American Health Organization and electronic newspapers were searched concerning medicine quality and in LAC.

Drug treatment improves the quality of life while decreasing morbidity and mortality among diseased populations. Absence of or inadequate testing laboratories, old and ineffective legislature, lack of enforcement or willpower and lack of effective surveillance are challenges in LAC for the proliferation of substandard and falsified medicines (SFMs).

The most significant limitation of this study was the need for the reviewers to have used articles written in other languages besides English. The LAC region has a large population in non-English-speaking countries, and many articles are written using local languages. Hence, excluding those articles is a limitation worthy of note in this review. The articles accessed needed to provide adequate information on SFM markets and illegal pharmacies or hospitals but did not. Future reviews may focus on providing illegal substandard and falsified medicines markets in the region and how they can be minimized or eliminated.

This review highlights the challenges faced by LAC countries regarding substandard, fake and counterfeit medicines. The sources, prevalence and consequences of substandard and falsified drugs were identified to suggest the measures needed to curb the infiltration of low-quality medicines in LAC.

The purpose of this research is to study and analyze the literature that integrates Lean Six Sigma (LSS) approach with blockchain technology in different sectors for improved quality management.

This study presents a scoping review on the application of integrated LSS and blockchain technology in the manufacturing and healthcare sector. Further, the authors examined existing blockchain-based solutions on a variety of dimensions, including application area, technical approach, methodology, application scenario, various blockchain platforms, purpose, and monitoring parameters. The authors study LSS approaches in detail, as well as the key benefits that blockchain technology can enable. Finally, the authors discuss significant research problems to be addressed in order to develop a highly efficient, resilient, and secure quality management framework using blockchain technology.

It has been observed that the adoption of blockchain technology for quality management and assurance is influenced by several factors such as transaction execution speed, throughput, latency. Also, prior blockchain-based solutions have neglected to leverage the benefits of LSS methodologies for effective quality management.

This is the first study to explores the influence of blockchain technology on quality management and assurance in manufacturing and healthcare industry. Furthermore, prior research has not examined how integrating the LSS methodology with blockchain technology can aid in the control of product quality management.

Almost five years after legalization, the unlicensed cannabis market is still thriving in Canada, and legacy cannabis retailers continue to face barriers to legal market entry. This study aims to shed light on these challenges and offer policy recommendations supporting legacy retailers and the government’s goals of enhancing public safety and displacing the unlicensed market.

This study reviewed online sources, including the media, gray literature, government, and other policy and legal websites, to identify legacy retailers’ challenges to entering the Canadian ecosystem since legalization and policy approaches of legalized jurisdictions with similar issues.

Legacy retailers face financial, legal and social barriers to entering the legal market. The Canadian government should focus on lowering and eliminating these barriers by developing programs that reduce financial risks and required capital, facilitate partnership programs and accelerators, provide innovative options that reduce overhead expenses, encourage pooled ownership to support small businesses, prioritize market entry for equity-deserving individuals and enable automatic expungement. A description of programs that have been implemented in other jurisdictions to address similar barriers is provided.

The policy recommendations in this paper would enable increased entrepreneurship and employment in a growing sector. While the tax revenue earned from the new market entrants may not be enough to support all the recommended policy initiatives, it could be reinvested to fund some of them creating sustainable growth opportunities.

The paper provides practical, timely policy recommendations on expanding the legal cannabis market in Canada and addressing unintended negative consequences of current policies.

Disruptions and shortages of drugs have become severe problems in recent years, which has triggered strong media and public interest in the topic. However, little is known about the factors that can be associated with the increased frequency of shortages. In this paper, the authors analyze the drivers of drug shortages using empirical data for Germany, the fourth largest pharmaceutical market.

The authors use a dataset provided by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with 425 reported shortages for drug substances (DSs) in the 24-month period between May 2017 and April 2019 and enrich the data with information from additional sources. Using logistic and negative binomial regression models, the authors analyze the impact of (1) market characteristics, (2) drug substance characteristics and (3) regulatory characteristics on the likelihood of a shortage.

The authors find that factors like market concentration, patent situation, manufacturing processes or dosage form are significantly associated with the odds of a shortage. The authors discuss the implications of these findings to reduce the frequency and severity of shortages.

The authors contribute to the empirical research on drug shortages by analyzing the impact of market characteristics, DS characteristics and regulatory characteristics on the reported shortages. The authors’ analysis provides a starting point for better prioritizing efforts to strengthen drug supply as it is currently intensely discussed healthcare authorities.

Drawing on information processing view (IPV) theory, the objective of this study is to explore big data analytics (BDA) in pharmaceutical supply chain (PSC) for better business intelligence. Supply chain operations reference (SCOR) model is used to identify and discuss the likely benefits of BDA adoption in five processes: plan, source, make, deliver and return.

Semi-structured interviews with managers in a triad comprising pharmaceutical manufacturers, wholesalers/distributors and public hospital pharmacies were undertaken. NVivo software was used for thematic data analysis.

The findings revealed that BDA capability would be more practical and helpful in planning, delivery and return processes within PSC. Sourcing and making processes are perceived to be less beneficial.

The study informs managers about the strategic role of BDA capabilities in SCOR processes for improved business intelligence.

Adoption of BDA in SCOR processes within PSC is a step towards resolving the challenges of drug shortages, counterfeiting and inventory optimisation through timely decision. Despite its innumerable benefits of BDA, Australian PSC is far behind in BDA investment. The study advances the IPV theory by illustrating and strengthening the fact that data sharing and analytics can generate real-time business intelligence helping in better health care support through BDA-enabled PSC.