Medical Product Supply Research Articles

Examining the roles and relationships of actors in community health systems in Nigeria through the lens of the expanded health systems framework

BackgroundCommunity health system (CHS) exists through the actions and activities of different actors within and outside communities. However, these actors, their roles and their relationships with one another have not...

Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation

BackgroundNational Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the identification of substandard and falsified medicines, the changes in the functions and key indicators of assessment, and the quality improvement changes of the Pharmacy Board of Sierra Leone.MethodsData was obtained from 2013 to 2021 records using a data collection tool to collate and review all relevant information to address the different objectives. All data were sourced from the Department of Quality Assurance and the Department of Enforcement and Narcotics at the Pharmacy Board of Sierra Leone. The review also included, identified substandard and falsified medicines, the World Health Organisation Global benchmarking self-assessment tool, and internal and external audit records of the quality management system of all twelve departments of the Pharmacy Board of Sierra Leone.ResultsThe study showed marked changes in identifying substandard and falsified medicines by the Pharmacy Board of Sierra Leone during ISO 9001:2015 implementation (2017- 2020) compared to Pre-ISO 9001:2015 implementation (2013- 2016). Critical functions of the Pharmacy Board of Sierra Leone from the assessment of the WHO GBT ML in 2016 and 2021 showed that several indicators had been addressed during ISO 9001:2015 certification with improvement in the level of maturity for the quality management systems and Pharmacovigilance functions. There was also an improvement in identifying non-conformances and a commitment to continuous improvement of processes during ISO 9001:2015 implementation.ConclusionsThis study revealed that regular checks through standard assessment, internal audits, and standard management review processes that generate follow-up actions, timelines, and a commitment to identifying correction, and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of an institution (Pharmacy Board of Sierra Leone). Our study revealed that commitment to continuous implementation of proper quality management system could significantly improve institutional efficiency, thereby improving service delivery and customer satisfaction.

Enhancing sustainability in medical product supply chains: The role of remanufacturing and government subsidies

This study explores the impact of government subsidies on the production dynamics within the medical product supply chain, particularly focusing on the remanufacturing of medical goods. Amidst the backdrop of the COVID-19 pandemic, which has underscored the critical shortages in medical supplies, our research delves into the adoption of remanufacturing practices by medical product manufacturers as a strategic response to these shortages and environmental concerns. We investigate how government subsidies influence the production volumes of original manufacturers and remanufacturers and examine the competitive interplay between newly manufactured and remanufactured medical products. Through the development of three production game models—Scenario B (manufacturers produce both new and refurbished products), Scenario N (separate production of new and refurbished products by manufacturers and remanufacturers, respectively), and Scenario C (similar to Scenario N but includes a certification fee paid by remanufacturers to original manufacturers)—we analyze the strategies that could mitigate supply deficiencies during medical crises. Our findings indicate that the certification strategy (Scenario C) not only yields the highest total production of medical products but also offers a viable solution to enhance the sustainability of the entire medical production system by alleviating supply chain disruptions. Furthermore, we discuss the managerial implications of our results, emphasizing the potential of a joint remanufacturing strategy to stabilize the supply chain and foster environmental conservation. Lastly, we highlight our study's limitations and suggest future research directions, particularly concerning the variability in product quality and the reliance on government subsidies. This research contributes to a nuanced understanding of green remanufacturing within the pharmaceutical supply chain, offering insights for manufacturers, remanufacturers, and policymakers aiming for sustainable industry practices.

Drone a technological leap in health care delivery in distant and remote inaccessible areas: A narrative review.

In developing countries, last-mile delivery of medical products is a challenge, especially in hilly and rural areas where there is no road connectivity. As helicopters or other air services are not affordable all the time, drones can be used for the supply of medical products. They are cost-effective as compared to other air or road transport. However, the carrying capacity of drone is less, it is not able to carry heavier payloads. Also, operating drones requires trained operators, and it is a new venture in a developing country so possibilities of confusion and lack of clarity on operating procedures are there. Drones are becoming increasingly reliable for the health care delivery. This narrative review explores the use of drones in healthcare delivery globally.

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea.

Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness. The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

Stockpiling at the Onset of the COVID-19 Pandemic: An Empirical Analysis of National Prescription Drug Sales and Prices

At the onset of the coronavirus (COVID-19) pandemic, hospitals experienced a demand surge for COVID-19–related medical care while simultaneously struggling to source prescription drugs needed to manage COVID-19 patients. This is worrisome as shortfalls in the supply of essential drugs can negatively impact patient outcomes. The popular press reporting on these challenges suggests that they are caused by supply chain disruptions. However, rigorous research on the relationship between the pandemic and prescription drug supply is limited. To address this gap, we leverage a quasi-experimental design and IQVIA’s National Sales Perspectives™ data from 2018 to 2020. We focus on prescription drugs indicated for the management of COVID-19 patients and a set of control drugs (i.e., drugs not used for COVID-19). We find that in the early phases of the pandemic, hospitals stockpiled prescription drugs indicated for the management of COVID-19, making this behavior an under-recognized cause of the sourcing challenges. The sales volume of drugs indicated for COVID-19 management was concentrated in the first two months of the pandemic, after which sales decreased significantly despite a nationwide increase in COVID-19–related hospitalizations. We investigate another potential cause of stockpiling: expected price increases. Counter to concerns of price gouging, we find little evidence of price inflation for these drugs. An implication for drug manufacturers is that orders due to stockpiling by downstream buyers early on in a pandemic may need to be discounted when predicting future demand. Our results have implications for drug suppliers, hospitals, and policymakers interested in improving medical product supply chain resilience. This paper was accepted by Stefan Scholtes, healthcare management. Funding: R. M. Conti was supported by the National Science Foundation (Grant 1123649-463157) and the Sloan Foundation. Supplemental Material: The online appendices and data files are available at https://doi.org/10.1287/mnsc.2021.04150 .

Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine.

When an initial marketing authorization of a pharmaceutical product is granted, a substantial number of chemistry, manufacturing, and control (CMC) post approval changes (PACs) have to be managed by the manufacturers. Despite efforts undertaken over the years by multiple regulatory jurisdictions, there is still heterogeneity in terms of regulatory requirements and timelines across national regulatory authorities (NRAs). This creates complexity in managing global CMC PACs, putting the supply of medical products at risk. Regulators have developed regulatory mechanisms that aim at accelerating the reviews and approvals of PACs by NRAs. The World Health Organization (WHO) is supporting the concept of "reliance" among NRAs, which are encouraged to rely on the assessment completed by a "highly performing authority". The objective is to accelerate the overall process for PACs, ultimately fostering more equitable and timely access to medical products for populations who need them. With the support of Health Canada, WHO, Pan American Health Organization, and the Paul-Ehrlich-Institut, Sanofi has launched a pilot using the principles of reliance for a CMC PAC for a vaccine, with 21 NRAs who accepted to participate in the pilot. The objective of this pilot was to apply these principles to reduce the approval timeline to a maximum of 6 months in all countries after an initial approval is granted by a reference authority. We discuss the opportunities and challenges of implementing reliance principles for CMC PACs. We also describe the pilot experience by sharing initial lessons learned from the Step 1 of this pilot, which consisted of engaging the reference authority and the NRAs.

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

ObjectiveTo explore the impact of the Coronavirus disease 2019 (COVID-19) pandemic on the quality of medical products in Zimbabwe, including market risks for substandard and falsified products and impacts on...

Predictive stability, novel HPLC-MS analysis and semi-automatic compounding process for the emergency implementation of a production line of pancuronium in injectable solution.

During the early months of the COVID-19 pandemic, the international medical product supply chain was tight, causing breaks in the availability of neuromuscular blocking agents essential for the treatment of patients in intensive care units. The present study describes the pharmaceutical development of an injectable 2 mg/mL solution of pancuronium bromide (PC) in a very short lapse of time. The sterile solution was compounded into a good manufacturing practice grade A clean room, filtered (0.2 µm) and filled into 10 mL type I glass, manually sealed with bromobutyl rubber stoppers. A novel HPLC-MS stability indicating method for pancuronium quantification and its degradation product was developed and validated. This fast, sensitive and straightforward method was used to study the stability of the formulation using a semi-predictive method, enabling a very fast attribution of a temporary shelf-life, which was confirmed by a classic prospective stability study. The production line and the analytical tools set-up were performed in six weeks and the semi-predictive stability study was conducted in 90 days, allowing us to predict a shelf life, which was successfully confirmed by prospective study. In conclusion, using innovative methods, we were able to rapidly overcome the shortage of a critical drug.

Shortages of agents used to treat antimuscarinic delirium

IntroductionAntimuscarinic delirium (AD), a potentially life-threatening condition frequently encountered by emergency physicians, results from poisoning with antimuscarinic agents. Treatment with physostigmine and benzodiazepines is the mainstay of pharmacotherapy, and use of dexmedetomidine and non-physostigmine centrally-acting acetylcholinesterase inhibitors (cAChEi) such as rivastigmine has also been described. Unfortunately, these medications are subject to drug shortages which negatively impact the ability to provide appropriate pharmacologic treatment of patients with AD. MethodsDrug shortage data were retrieved from the University of Utah Drug Information Service (UUDIS) database from January 2001 through December 2021. Shortages of first-line agents used to treat AD (physostigmine and parenteral benzodiazepines) and second-line agents (dexmedetomidine and non-physostigmine cAChEi) were examined. Drug class, formulation, route of administration, reason for shortage, shortage duration, generic status, and whether the drug was a single-source product (made by only one manufacturer) were extracted. Shortage overlap and median shortage durations were calculated. ResultsTwenty-six shortages impacting drugs used to treat AD were reported to UUDIS from January 1, 2001 to December 31, 2021. Median shortage duration for all medication classes was 6.0 months. Four shortages were unresolved at the end of the study period. The single medication most often on shortage was dexmedetomidine, however benzodiazepines were the most common medication class on shortage. Twenty-five shortages involved parenteral formulations, and one shortage involved the transdermal patch formulation of rivastigmine. The majority (88.5%) of shortages involved generic medications, and 50% of products on shortage were single-source. The most common reported reason for shortage was a manufacturing issue (27%). Shortages were often prolonged and, in 92% of cases, overlapped temporally with other shortages. Shortage frequency and duration increased during the second half of the study period. ConclusionShortages of agents used in the treatment of AD were common during the study period and affected all agent classes. Shortages were often prolonged and multiple shortages were ongoing at study period end. Multiple concurrent shortages involving different agents occurred, which could hamper substitution as a means of mitigating shortage. Healthcare stakeholders must develop innovative patient- and institution-specific solutions in times of shortage and work to build resilience into the medical product supply chain to minimize future shortages of drugs used for treatment of AD.

Government Procurement Defence Under GATT 1994 Article III:8(a): A Critical Review of the Turkey-Pharmaceutical Products Dispute

This article critically reviews the Turkey-Pharmaceutical Products Dispute, focusing on the question of whether Turkey’s drug insurance reimbursement scheme can be regarded as government procurement, which would allow Turkey’s drug production localization policy to be exempt from national treatment obligation. Both the panel (on the account that there was no ownership by the government) and the arbitrators (on the account that there was insufficient control of pharmaceutical products subject to the dispute), ruled against Turkey’s government procurement defence. In contrast, this article argues that given rising health costs and repeated global pandemics which compel governments to build up sufficient national production capability of health products to facilitate timely supply of medical products, it would be desirable to take a broad approach towards interpreting the scope of Article III:8(a) with respect to the pharmaceutical sector, granting greater policy space for member governments. pharmaceuticals, government procurement, national treatment, Article III:8(a) derogation, drug insurance reimbursement, domestic localization policy, health policy, Turkey

Globale Warenketten und Versorgungsengpässe in Österreich mit Medizinprodukten in der COVID-19-Pandemie

The COVID-19 Pandemic led to a strong increase in demand for medical products. At the same time, supply problems in international supply chains kicked in due to health policy interventions (e.g., lockdowns) and economic policy measures (e.g., export controls). Combined, both resulted in temporary shortages and triggered a controversial discussion about the advantages and disadvantages of globalised production structures, which led to strong dependencies on a few, primarily Asian, locations and producers. Against this background and based on case studies for Austria, the article deals with the question which factors determine the robustness of global commodity chains for respirators, protective gloves and respiratory equipment and which national and European policies could be suitable for increasing resilience in the supply of medical products.

Freedom of Establishment of Pharmacies in the Case Law of the Court of Justice of the European Union

The objective of the European Union’s healthcare policy is to protect and improve the health of people at a European level. At the same time, actions taken by European bodies are merely complementary to national health policies. This means that the concepts of national health systems, including access to the pharmacy business, lie within the scope of powers of individual member states. Legal regulations governing the operation of pharmacies are not harmonised and, hence, national systems are not homogeneous. Currently, national pharmacy business models vary from one EU member state to another, depending on adopted legal solutions as well as political and economic context in which pharmacies operate. The problem which thus arises is whether the legal regulations that impose certain restrictions on the pharmacy business can be deemed violating the freedom of establishment in the European Union. An analysis of the Court of Justice’s jurisprudence leads to a position that the EU law does not stand in the way of national regulations that make the right to operate a pharmacy conditional on the possession of pharmaceutical education, if certain conditions are met. In the light of the Court’s line of jurisprudence, restrictions on the freedom of establishment should be applied without discrimination on grounds of nationality, and should be justified by overriding reasons of general interest, should be suitable to achieve legitimate objectives and should not go beyond what is necessary for the achievement of these objectives. Furthermore, the protection of public health and the duty to provide the population with a steady supply of medical products of proper quality seem to outweigh the freedom to conduct business under the treaties

Government strategies to secure the supply of medical products in pandemic times

We investigate how to secure reliable access to personal protective equipment (PPE) in pandemics, which are characterized by random occurrences and durations, at the lowest expected cost. The policymaker’s strategy is based on a mix of (1) holding ready-to-use strategic stockpile that is acquired at regular price but incurs a holding cost, (2) building partnership with PPE manufacturers to relocate offshore production locally, which guarantees some local supply but requires offering subsidies, and (3) buying PPE from the spot market, which is characterized by long supply lead times and high prices.We model the problem as a Stackelberg game between a policymaker (leader) and a manufacturer (follower). The policymaker decides the PPE stockpile, the subsidy offered to the local manufacturer, and the quantity to buy from the spot market. The manufacturer determines whether to move production onshore. We determine the optimal strategy for each player and study the effect of spot market conditions and pandemic characteristics.Analytical results show that attracting local manufacturers is less costly for the government when the variability of pandemic duration increases. While it is sub-optimal to rely only on the strategic stockpile, holding some stockpile may be necessary even when the PPE can be obtained from the spot market as soon as the pandemic starts. Results reveal policymaker’s preference for subsidizing onshore production in the following cases: products with low spot prices (counter-intuitively), spot market with long supply lead time, less frequent pandemics, and shorter pandemics.

Industrial applications of 3D printing to scale-up production of COVID-19-related medical equipment.

Additive manufacturing or 3D printing allows the rapid conversion of information from digital 3D models into physical objects. The current COVID-19 crisis underscored the value of 3D-printing technology in addressing critical shortages in the medical product supply chain. This article provides a review of the significant role of additive manufacturing technologies in addressing the COVID-19 situation. This article concludes that 3D printing has an important role in global public health because of its potential to adapt to emerging situations far more easily and quickly as compared with conventional manufacturing methods. There is a need for further research to improve the technology to mass produce better quality products more economically. Currently, the 3D-printing industry is concentrated in the US and Western Europe. Policy efforts are needed to tap all markets across the globe in order to be better prepared for a future pandemic.

Examining the Effect of Export Restrictions on Medical Products under WTO during Covid-19 Pandemic

Export of medical instruments in midst of life-threatening pandemic crisis has increased significantly. However, the urgent supply of medical products faces the challenge of unprecedented protectionist restrictions introduced by several developed nations. These restrictions, introduced to avoid shortage of medical products in domestic market of such exporting countries, threaten the lives and livelihood of million others in immediate and urgent need of goods. The article examines the legality and effect of these restrictions under the extant WTO framework. Lastly, the article also highlights the necessity of international cooperation between nations to overcome partisan policies of self-interest and the imporatnce of collective efforts in this fight against a common threat.

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist

The U.S. capacity to manufacture key essential medications has diminished. The U.S. pharmaceutical supply chain (USPSC) has diversified and now relies on international sources of active pharmaceutical ingredients and finished drug products (FDPs). Despite years of effort raising concerns about the USPSC, pharmacists and pharmacy technicians continue to spend a substantial amount of time and energy responding to, and mitigating the impact of, medication shortages, drug recalls, and the adverse outcomes related to low-quality medications. The extent of U.S. reliance on foreign sources of medications is largely unknown. Pharmacists do not have a reliable way to determine the country of origin (i.e., source), capacity, or geographic location of pharmaceutical manufacturers, limiting our ability to anticipate challenges or mitigate risks to our Nation’s drug supply. The U.S. Food and Drug Administration’s task of regulating quality and safety is challenging and will likely require additional safeguards and resources. In addition to pharmacists’ engagement, solutions will likely need to leverage a mix of policy, economic incentives, and expanded objective surveillance testing. The U.S. pharmaceutical supply chain is complex, global, and goes beyond FDPs. The 2020 American Pharmacists Association House of Delegates has rightly asserted that “The quality and safety of pharmaceutical and other medical products and the global pharmaceutical and medical product supply chain are essential to the United States national security and public health.” Pharmacy professionals on the front line engage with patients, identify medication-related issues, and engage in drug-procurement decisions. Pharmacists are essential to our nation’s overall health and must be engaged in the development and implementation of strategies to safeguard the USPSC.

Blockchain based Information Architecture for Medical Product Supply Chain

Blockchain based Information Architecture for Medical Product Supply Chain

Impact of 3D printed medical equipment on the management of the Covid19 pandemic.

SummaryVery high mortality rates of coronavirus pandemic (COVID‐19) are observed around the world due to lack of medical equipment. The increased need for medical devices and personal protective equipment (PPE) has kept several healthcare professionals at risk. Fortunately, 3D printing technology allows to overcome the lack of medical supplies. This study highlights the impact of 3D printing on the combat against COVID19, and its importance in the medical product supply chain. Indeed, the existing medical equipment fabricated by 3D printing technology and its role in the management of Covid19 pandemic is presented. Moreover, the last works are examined to know whether the models of the medical equipment are free of use and whether useful informations are presented (eg, available design data and setup guidelines).

The consequence of COVID-19 on the global supply of medical products: Why Indian generics matter for the world?

While the world is facing the urgency of the COVID-19 pandemic, policymakers must plan for the direct response to the outbreak while minimising its collateral impact. Maintaining the supply chain of pharmaceutical products is not only paramount to cover the immediate medical response but will be fundamental to reducing disruption of the healthcare delivery system, which requires constant medicines, diagnostic tools and vaccines for smooth functioning. In this equation, the role of the Indian pharmaceutical industry will not only be critical to meet the domestic need of over 1.3 billion inhabitants but will equally be important for the rest of the world, including wealthy economies. Preventing a significant disruption of the Indian pharmaceutical supply chain during the outbreak and preparing it for large scale production for COVID-19 therapeutic or preventive medical products will not only help India but will assist the global response to this outbreak.