Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain

Drug counterfeits have been an international issue for almost two decades, and the latest statistics show that fake medications will continue to penetrate legitimate pharmaceutical supply chains (PSCs). Therefore, identifying the issues faced by PSCs is essential to combat the counterfeit drug problem, which will require the implementation of technologies in various phases of the PSC to gain better visibility. In this regard, a literature review was conducted to fulfill the following objectives: (i) review the application of traceability technologies in various PSC phases to detect counterfeits; (ii) analyze the various barriers affecting the establishment of a safe PSC and the critical success factors used to overcome those barriers; and (iii) develop a conceptual framework and guidelines to demonstrate the influence of traceability technologies and success factors on overcoming the various barriers in different phases of the PSC. The major finding of this review was that traceability technologies and the critical success factors have a significant influence on overcoming the barriers to establishing a safe PSC.

Counterfeiting: Exploring mitigation capabilities and resilience in South African pharmaceutical supply chains

Orientation: Pharmaceutical supply chains (SCs) are experiencing a growing emergence of illicit trade of counterfeited products. This threat is amplified because of global distributed SC networks, increased access to the Internet and challenging economic conditions.Research purpose: The purpose of this study was to explore risk mitigation capabilities and SC resilience (SCRES) to reduce the effects of counterfeiting in the South African pharmaceutical industry.Motivation for the study: Developing countries such as South Africa tend to be more vulnerable to counterfeiting, as these countries do not have established responses that are seen in more developed countries, such as SC regulation, track-and-trace technology and enforcement regimes.Research design, approach and method: This study employed a generic qualitative research design. Semi-structured interviews were used to collect data from 12 pharmaceutical manufacturers, distributors and retailers in the South African pharmaceutical industry. A thematic analysis approach was followed to analyse the collected data.Main findings: The findings show that the sources of counterfeiting stem from the local and outsourced manufacturing of counterfeited products, presence of unauthorised distributors and importing of counterfeit products. Risk awareness can be enhanced by collaborating with industry members, training members to identify counterfeits and by developing authentication technologies. The industry actively combats counterfeiting by using SCRES enablers including visibility, collaboration, information sharing and by developing an SC risk management culture.Practical/managerial implications: South African pharmaceutical firms have limited resilience. Therefore, managers should develop flexibility, agility, sensing and redundancy as resilience enables firms to combat counterfeiting.Contribution/value-add: This study expands the current literature by identifying the unique sources of counterfeiting and risk mitigation capabilities to combat counterfeiting in pharmaceutical firms in a developing country context.

Material convergence issue in the pharmaceutical supply chain during a disease outbreak

PurposePharmaceutical donations are a practical approach to increase medicine availability during disasters such as disease outbreaks. However, often donated pharmaceuticals are inappropriate and unsuitable. This convergence of inappropriate pharmaceuticals is a severe operational challenge and results in environmental hazards. This study explores the pharmaceutical supply chains (PSCs) during a disease outbreak to relieve the negative impact of the material convergence problem (MCP).Design/methodology/approachThis study adopts a situation-actors-process learning-action-performance (SAP-LAP) linkage framework to understand the PSC dynamics. The problem-solving component of the SAP-LAP analysis provides the strategies catering to MCP. The findings from the SAP-LAP helped to develop the causal loop diagram (CLD). This study conducts several experiments on the proposed strategies by integrating CLD into a stock and flow diagram. Later, a disease outbreak case study accessed the pharmaceutical donations effect on PSC performance.FindingsThe study synthesises and evaluates propositions and strategies to incorporate circular economy (CE) principles in PSC. This study proposed two strategies; one to sort and supply and the other to sort, supply and resell. The reuse policy improves humanitarian organisations' finances in the simulation study. This study verified the operational improvement of PSC by reducing the transport and storage burden due to MCP.Originality/valueThis study comprehensively approaches the issue of drug donation and uniquely produced several propositions for incorporating a CE perspective in PSC. The study also proposed a unique simulation approach to model the donation arrivals in response to a disease outbreak using susceptible, exposed, infectious and recovered modelling.

Pharmaceutical supply chains and management innovation?

Purpose This paper aims to evaluate the implementation of innovative programmes within the downstream domain of the pharmaceutical supply chain (PSC), with the aim of informing improved service provision. Design/methodology/approach A mixed-method approach was used to assess to what extent innovation could be adopted by hospital and community pharmacies to improve the delivery process of pharmaceutical products. Unstructured interviews and 130 questionnaires were collected and analysed to identify factors that facilitate or prevent innovation within PSC processes. Findings The analysis led to the creation of the innovative pharmaceutical supply chain framework (IPSCF) that provides guidance to health-care organisations about how supply chain management problems could be addressed by implementing innovative approaches. The results also indicated that the implementation of Lean and Reverse Logistics (RL) practices, supported by integrated information technology systems, can help health-care organisations to enhance their delivery in terms of quality (products and service quality), visibility (knowledge and information sharing), speed (response to customers and suppliers needs) and cost (minimisation of cost and waste). Practical implications The study’s recommendations have potential implications for supply chain theory and practice, particularly for pharmacies in terms of innovation adoption. The IPSCF provides guidance to pharmacies and health-care organisations to develop more efficient and effective supply chain strategies. Originality/value This research contributes to the academic literature as it adds novel theoretical insights to highly complex delivery process innovation.

Organised crime will gain from world vaccine shortages

Significance However, it is vast global demand for the restricted supply of COVID-19 vaccines that offers the most alluring prize for criminal gangs. Black markets thrive in situations where demand outstrips supply, and there has long been an illicit trade in medicines. Impacts Countries with underdeveloped pharmaceutical supply chains will be vulnerable to theft and diversion of vaccine supplies. Government vaccine strategies could be undermined by high-profile black market vaccine scandals that damage public trust. Pharmaceutical companies are vulnerable to reputational damage if their supply chains are found to be tampered with. Criminal profits will fund other illegal activities such as trafficking of people, drugs and arms.

Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond

Background Adequate quality systems throughout pharmaceutical supply chains are crucial to protect individuals and communities from substandard and falsified medical products. Thus, pharmaceutical distributors are regularly assessed by qualified experts. Since the COVID-19 pandemic has forced a suspension of normal activities, remote assessments via videoconferencing may represent a temporary alternative to on-site audits. We exploratorily evaluated the feasibility of remote assessments of pharmaceutical distributors, located in a low- or middle-income country hard-to reach during the COVID-19 pandemic. Methods We conducted pilot remote assessments of four conveniently selected distributors. The expert was remotely connected via videoconference, and supported by an in-country assessment facilitator (ICAF), who had received ad hoc training and was present at the assessed facility. First, the remote expert assessed the quality assurance (QA) activities and rated their compliance with the standards of the World Health Organization Good Storage & Distribution Practices (GSDP), as per routine practice. Second, s/he assessed the completeness, clarity and accuracy of data collected remotely, first per distributor, and then in aggregated form. Results Data completeness was assessed by the expert as excellent, while clarity and accuracy were good. Overall data quality (a combination of completeness, clarity and accuracy) was good, with no major differences across QA activities, nor across distributors. Contextual limitations included poor internet connection, language barriers, and distributors’ lack of familiarity with QA terminology. Conclusions Our findings are exploratory and cannot be extrapolated to other contexts, nor to other types of audits. Nonetheless, this pilot experience suggests that a well-planned remote assessment of pharmaceutical distributors, conducted with the support of a well-trained onsite ICAF, can provide data of acceptable quality, allowing to assess GSDP-compliance and to make temporary decisions about licensing or purchasing. Purchasers and policy makers should read the results of remote assessments in light of their intrinsic limitations. At the moment, onsite assessments remain the gold standards, but this could change in the longer term, with improved information technology and in light of the need to avoid unnecessary travels. Furthermore, remote assessments could be considered for routine pre-screening candidates for on-site assessments, and for targeted follow-up of on-site assessment.

Procurement 4.0 to the rescue: catalysing its adoption by modelling the challenges

PurposeThe pandemic crisis has resulted in global chaos that had caused massive disruption to the supply chain. The pharmaceutical industry, in particular, has been working tirelessly to ensure that they can cater to the people who need them. With restrictions being imposed to prevent the spread of the COVID-19 virus, the movement of raw materials required has been affected, thus creating the need for the procurement function to be innovative. This study proposes the application of Industry 4.0 concepts into the procurement activities of an organization to make it more resilient and efficient.Design/methodology/approachTo study the intensity of the challenges, Total Interpretive Structural Modelling is used alongside the “Matrice des Impacts Croises Multiplication Appliquee a un Classement” (MICMAC) technique.FindingsResilience can be achieved through the collaboration between the organization and its network of suppliers. This is however easier said than done. High and unclear investments have been identified as the challenge that is taking a toll on all technological investments in the pandemic era. The study also shows that organizational inertia which is present in established and structured firms are a deterrent as well.Originality/valueThis study is based on the application of procurement 4.0 to ensure that pharmaceutical supply chains stay least affected since they are essentials. This study using a multi-criteria decision-making approach to prioritize the challenges. This will help practitioners make decisions faster.