A dynamic management model for sustainable drug supply chain in hospital pharmacies in Iran.

BACKGROUND: Sustainable supply chain management encompasses the strategic coordination and control of material, information, and financial flows, as well as the collaborative efforts among the entities engaged in the medicinal supply chain. This research proposes a dynamic and sustainable supply chain management model tailored explicitly for the inpatient pharmacies of Medical Centers and Hospitals affiliated with Iran University of Medical Sciences. METHODS: This is a quantitative study in terms of research objective and a qualitative study based on the stages in the conceptual development of the model. Therefore, the current study can be considered a mixed-methods approach. After identifying the key factors influencing the sustainability of the medicine supply chain, we conducted a dynamic analysis of the problem using system dynamics methodology. In order to simulate the system's behavior over 24 months, we utilized a combination of existing documentary information and expert opinions. The developed model was implemented using Vensim PLE software, allowing us to simulate and analyze the impact of various policies on the system. RESULTS: Medicine disposal exhibited an upward trend, particularly during the second 12-month period. Conversely, the trend of medicine expirations remained relatively stable in the initial months but showed an upward trajectory after that. The cost associated with disposed medicine experienced a consistent increase, with a higher rate observed during the second 12-month period. In contrast, sales of low-consumable medicine experienced a significant initial surge followed by a slower growth rate. Finally, the pharmacy's profit demonstrated an overall increasing trend, although the rate of increase was higher during the first 12 months. CONCLUSION: Among the various scenarios considered, namely "increasing the adequacy of human resources," "increasing the speed of response," and "utilizing pharmacists in the drug prescribing team," it was found that these interventions had a substantial effect on both enhancing the pharmacy's profit and reducing medication waste. Therefore, these scenarios were identified as having the most significant impact. The proposed model can serve as a valuable tool for forecasting and informing policy-making, providing insights into addressing the challenges associated with the sustainable drug supply chain in hospital pharmacies.

[Managing medicine shortages: responsibilities and strategies at the Swedish Medical Products Agency]. / Restsituationer för läkemedel ­ uppdrag och ansvarsfördelning.

The paper outlines the role of the Swedish Medical Products Agency (Läkemedelsverket) in managing medicine shortages. The agency receives reports from pharmaceutical companies, investigates causes, and disseminates information to pharmacies, healthcare providers, and the public. While focusing on mitigating shortages, the agency clarifies its non-involvement in manufacturing or sales decisions. Pharmaceutical companies must promptly report shortages, with sanctions enforced for non-compliance. Various measures, including regulatory actions, interchangeable medicines, temporary dispensations, and licensing, are employed to address shortages. Additionally, the agency advocates for stable national drug supply preparedness, emphasizing collaboration and governmental intervention.

The Medicines Center and pharmaceutical care during the civil-military dictatorship (1970-1974). / A Central de Medicamentos e a assistência farmacêutica na ditadura civil-militar (1970-1974).

The present article analyzes the formation of the first pharmaceutical care policies implemented by the Brazilian Federal Government between 1968 and 1974, during the civil-military dictatorship. It examines a set of measures adopted by the Costa e Silva and Médici governments to contain a continuous rise in the prices of raw materials and pharmaceutical specialties, with this context being essential to the creation of the Medicines Center (CEME) in 1971. The core argument of the article is that CEME represented, at the federal level, the consolidation of a policy carried out at the National Institute of Social Security (Instituto Nacional da Previdência Social - INPS) between 1968 and 1970, based on the production of inputs and medicines in public laboratories. Ended in 1970, this policy was resumed the following year with broad participation of military personnel and laboratories of the Armed Forces. The originality of this article lies in its explanation of how such support influenced the establishment of CEME in its early years. Until 1974, military members were the majority in the Board of Directors of CEME, with some of the agency's early missions being the supplier for Civil-Social Actions of the Armed Forces.

O artigo analisa a formação das primeiras políticas de assistência farmacêutica executadas pelo Governo Federal brasileiro entre 1968 e 1974, durante a ditadura civil-militar. Examina um conjunto de medidas adotadas pelos governos Costa e Silva e Médici para conter uma contínua elevação nos preços de matérias-primas e especialidades farmacêuticas, sendo este contexto fundamental para a criação da Central de Medicamentos (CEME), em 1971. O argumento central do artigo é o de que a CEME representou a consolidação, em âmbito federal, de uma política realizada no Instituto Nacional da Previdência Social (INPS) entre 1968 e 1970, baseada na produção de insumos e medicamentos em laboratórios públicos. Encerrada em 1970, esta política foi retomada no ano seguinte com ampla participação de militares e laboratórios das Forças Armadas, sendo a originalidade deste artigo explicar como tal apoio influiu na montagem da CEME em seus primeiros anos. Até 1974, os membros militares eram majoritários na Comissão Diretora da CEME, sendo algumas das primeiras missões da autarquia o abastecimento de Ações Cívico-Sociais das Forças Armadas.

Identifying Medicine Shortages With the Twitter Social Network: Retrospective Observational Study.

BACKGROUND: Early identification is critical for mitigating the impact of medicine shortages on patients. The internet, specifically social media, is an emerging source of health data. OBJECTIVE: This study aimed to explore whether a routine analysis of data from the Twitter social network can detect signals of a medicine shortage and serve as an early warning system and, if so, for which medicines or patient groups. METHODS: Medicine shortages between January 31 and December 1, 2019, were collected from the Dutch pharmacists' society's national catalog Royal Dutch Pharmacists Association (KNMP) Farmanco. Posts on these shortages were collected by searching for the name, the active pharmaceutical ingredient, or the first word of the brand name of the medicines in shortage. Posts were then selected based on relevant keywords that potentially indicated a shortage and the percentage of shortages with at least 1 post was calculated. The first posts per shortage were analyzed for their timing (median number of days, including the IQR) versus the national catalog, also stratified by disease and medicine characteristics. The content of the first post per shortage was analyzed descriptively for its reporting stakeholder and the nature of the post. RESULTS: Of the 341 medicine shortages, 102 (29.9%) were mentioned on Twitter. Of these 102 shortages, 18 (5.3% of the total) were mentioned prior to or simultaneous to publication by KNMP Farmanco. Only 4 (1.2%) of these were mentioned on Twitter more than 14 days before. On average, posts were published with a median delay of 37 (IQR 7-81) days to publication by KNMP Farmanco. Shortages mentioned on Twitter affected a greater number of patients and lasted longer than those that were not mentioned. We could not conclusively relate either the presence or absence on Twitter to a disease area or route of administration of the medicine in shortage. The first posts on the 102 shortages were mainly published by patients (n=51, 50.0%) and health care professionals (n=46, 45.1%). We identified 8 categories of nature of content. Sharing personal experience (n=44, 43.1%) was the most common category. CONCLUSIONS: The Twitter social network is not a suitable early warning system for medicine shortages. Twitter primarily echoes already-known information rather than spreads new information. However, Twitter or potentially any other social media platform provides the opportunity for future qualitative research in the increasingly important field of medicine shortages that investigates how a larger population of patients is affected by shortages.

Drug supply and assurance: a cross-sectional study of drug shortage monitoring varieties in China.

BACKGROUND: Drug shortage is a worldwide problem that seriously threatens public health. China released the most comprehensive list of key drug shortage monitoring varieties ever in 2022. We aim to analyze the attributes and characteristics of the medicines within the list to provide a reference for improving China's supply security of shortage drugs. METHODS: We used public data to extract information on drug types, dosage forms, indications, classification of clinical uses, whether they were included in medical catalogs such as the National Essential Drugs, and the number of drug and active pharmaceutical ingredient (API) manufacturers. A descriptive statistical analysis was used. RESULTS: Of the 980 drugs on the list, 99.59% were chemicals and 92.65% were injectables. Drugs for blood and hematopoietic organs, the cardiovascular system, and the digestive tract and metabolism ranked among the top three shortages. Verification of the medical catalogs showed that 90.41% of the drugs belonged to the national essential drugs, 95.10% were medicare drugs, 2.55% were volume-based procurement drugs, and 14.70% were for rare diseases, and 42.04% were for children. In terms of drug supply capacity, 21.33% of drug approvals are less than 10, and there were even 26 drugs for exclusive production, close to 90% of manufacturers need to purchase APIs from outside. Among the 256 APIs included in the list, 152 APIs had less than 10 manufacturers, and there were even 5 APIs produced by only one enterprise nationwide. CONCLUSIONS: The situation of drug shortages in China was severe and complex, with serious shortages of medicines adapted to basic medical and healthcare needs and clinically necessary medicines, and a need to improve the production capacity of drugs and the ability to supply APIs. We recommend strengthening drug monitoring and stockpiling and accelerating the approval of shortage drugs to improve drug supply security.

[On the issue of logistic support of export of medicinal preparations of national production].

The current geopolitical situation raised pointed question of developing new supply chains and looking for rolling stock to develop newly formed cargo flows, including medicinal preparations transportation. Considering necessity in timely and safe supply of medicines, it is necessary to develop set of measures permitting to implement export of this production of national industry to ensure ultimate independence from unfriendly states. The article considers main indicators of import and export operations of medicinal preparations and measures taken by the state to support industry in current conditions, requirements for international transportation of this category of goods. The measures increasing exports within the framework of the Pharmaceutical Industry Development Strategy until 2030, such as expansion of fleet of autonomous refrigerated containers, use of consolidation warehouses in Turkey and Kazakhstan to ensure decreasing of cost of multi-modal transportation of medicinal preparations, as well as validation of rolling stock in accordance with GDP requirements.

[The long 1992 in medicinal (non-)security of Russia. Report II. Market networks and institutes].

The year of 1992 is very important milestone in history of Russian pharmaceutical market. It began not in January 1922, but in December 1991, when the President and Government enactments to open free market for medications were promulgated. The advisers of B. N. Yeltsin considered market economy as reliable mean to overcome medicinal deficiencies, corruption and bureaucratic monopoly. However, panacea did not work. Moreover, it caused completely new problems. The human and state security implies protection from threats of dependencies. The unprepared dive into market plunged Russians and the country into severe dependence on import of medications and foreign pharmaceutical companies. The proposed study expands our publications in this journal and in journal "Pharmacy" in 2022. At that time, analysis of medication scarcity was implemented on the basis of published sources and relied on journalistic evidences. The current study is carried out on the basis of archival documents of the Ministry of Health Care of the Russian Federation and authors interviews of representatives of regulator. The second report reconstructs the sequence of the emergence and correlation of the structural elements of the Russian pharmaceutical market.

Cheaper is not always better: Drug shortages in the United States and a value-based solution to alleviate them.

Drug shortages threaten patients' access to medications and are associated with adverse health outcomes and increased costs. Drug shortages disproportionately occur among generic drugs of limited profitability, most notably drugs administered by injection. In this perspective, we discuss how reimbursement and purchasing practices that were meant to create an efficient marketplace for generics have generated strong price pressure that threatens profitability in certain markets. We further explain how, faced with limited profitability, manufacturers lack incentives to invest in resilient supply chains, and in some cases, engage in cost-containment strategies or decide to exit the market, ultimately contributing to shortages. We propose the development and implementation of value-based reimbursement to provide needed incentives for drug purchasers and manufacturers to establish a more reliable supply chain as part of the policy solution to reduce the number and extent of drug shortages. This reimbursement model would necessitate the development of a rating system that measures supply chain resilience and maturity for each generic product. This rating would then be applied as a value-based modifier to reimbursement rates for generic products. The proposed model would result in higher reimbursement rates for generic products from more dependable supply chains, generating incentives for manufacturers to invest in supply chain resiliency. We propose the application of this reimbursement system originally in Medicare given Congressional interest on reforming Medicare payment to prevent drug shortages.

Coping with drug shortages: A study of government-enterprise option cooperation stockpiling strategies for drugs in shortage considering API surrogate stockpiling subsidies.

Drug shortage is a global problem, and the development of government-enterprise cooperative stockpiles of drugs in shortage, combining physical and production capacity, has become one of the most important means of coping with drug shortages. However, existing studies have tended to overlook the fact that shortages of Active Pharmaceutical Ingredients (APIs) have become an important constraint on production capacity stockpiling and that the lack of incentives and provisions for coordination of benefits have led to a double marginal effect of joint stockpiling by government and enterprises of drugs in shortage. Accordingly, this study introduced the option contract to the drug supply system composed of government and pharmaceutical enterprises and used the subsidy of API storage in lieu as an important initiative to incentivize the reserve of APIs, to construct a model of shortage drug reserve under the government's leadership. This study aims to improve the effect of government-enterprise joint stockpiling of drugs in shortage, which is of great theoretical and practical significance. According to the classification of production license types of pharmaceutical enterprises, this study established a three-level supply chain decentralized decision-making model consisting of the government, formulation enterprises, and API enterprises, and a two-level supply chain centralized decision-making model consisting of the government and API Formulation (API-F) integrated enterprises, respectively. By solving the inverse order derivation, the government-enterprise option cooperation conditions and optimal decision-making strategy were derived. The study results showed that: (i) The addition of enterprise API stockpiling mode can help the government conventional reserves, and enterprise production capacity reserves, broaden the way of drug reserves, and improve the effect of government-enterprise option cooperation; (ii) when the probability of drug shortages is high, the government should prefer the cooperation of API-F integrated enterprises, which is conducive to reducing intermediate links and government costs and improving the supply responsiveness to shortages of medicines; (iii) Setting appropriate government subsidies for API storage can incentivize enterprises to stockpile APIs and improve drug production capacity and physical supply response capability. This study took the problem of socialized stockpiling of drugs in shortage as an entry point and explored the problems and solution strategies in the government-enterprise cooperative stockpiling of drugs in shortage, which not only made some theoretical contributions to the application of options contract in the government-enterprise cooperative stockpiling of drugs in shortage but also provided new ideas and theoretical basis for the improvement of the stockpiling work of drugs in shortage.

Public Good versus Private "Goods": Ethical Implications of Drug Shortages on Anesthesiology Practice.

Drug shortages remain a serious and widespread problem affecting all health systems and patients. Anesthesiology practice is strongly impacted by shortages of sterile injectable drugs, resulting in a negative impact on the quality of care. Understanding the root causes of drug shortages guides the anesthesiologist toward an ethical response. While rationing is a common consideration in secular ethics, and indeed rationing strategies are utilized, the use of rationing alone risks normalizing and perpetuating the drug shortage problem. Drug shortages are the direct result of a market failure brought on by lack of oversight of drug production standards in some cases as well as by the impact of intermediary purchasing groups on costs and availability of drugs. Legislation needs to reestablish a responsible, competitive, and robust manufacturing drug market.

HCSRL: hyperledger composer system for reducing logistics losses in the pharmaceutical product supply chain using a blockchain-based approach.

Blockchain technology uses a secure and decentralised framework for transaction management and data sharing within supply chains. This is particularly crucial in the pharmaceutical industry, where product authenticity and traceability are paramount. Blockchain plays a pivotal role in preventing product loss and counterfeiting, while simultaneously enhancing transparency and efficiency throughout the supply chain. The research introduces a step-by-step approach to implementing a proof-of-concept (PoC) for Supply Chain Risk Management (SCRM) through blockchain technology. This PoC involves simulating a supply chain process to assess feasibility and measure key performance indicators. Engaging stakeholders and gathering feedback is integral to refining the blockchain-based SCRM system. The study rigorously evaluates the performance of the SCRM blockchain across various test scenarios, featuring differing numbers of organizations and clients. Multiple fabric networks are employed to assess the system's scalability and performance under diverse conditions. The results of these comprehensive tests inform practical deployment decisions and highlight areas for potential optimization and further development. So this research provides valuable insights into the application of blockchain in pharmaceutical supply chains, offering a roadmap for implementation and improving supply chain security, efficiency, and transparency.

A proposed analytical framework for qualitative evaluation of access to medicines from a health systems perspective.

OBJECTIVE: Despite global recognition that access to medicines is shaped by various interacting processes within a health system, a suitable analytical framework for identifying barriers and facilitators from a system's perspective was needed. We propose a framework specifically designed to find drivers to access to medicines from a country's health system perspective. This framework could enable the systematic evaluation of access across countries, disease areas and populations and facilitate targeted policy development. This framework is the byproduct of a larger study on the barriers and facilitators to childhood oncology medicines in South Africa. RESULTS: Eight core (pharmaceutical) functional processes were identified from existing frameworks: (I) medicine regulation, (II) public financing and pricing, (III) selection, (IV) reimbursement, (V) procurement and supply, (VI) healthcare delivery, (VII) dispensing and (VIII) use. National contextual components included policy and legislation and health information systems. To emphasize the interlinkage of processes, the proposed framework was structured as a pharmaceutical value chain. This framework focusses on national processes that are within a country's control as opposed to global factors, and functional mechanisms versus a country's performance or policy objectives. Further refinement and validation of the framework following application in other contexts is encouraged.

The empty code cart: Drug shortages over time.

PURPOSE: In high-acuity situations such as cardiac arrest, clinicians rely on prepared medications stocked in code carts to provide timely and accurate pharmacotherapy. We examined shortage trends for medications commonly used in code carts. METHODS: Drug shortage data from 2001 to 2022 were retrieved from the University of Utah Drug Information Service (UUDIS) to characterize shortages reported for commonly used code cart medications. Data extracted included the number of shortages, shortage duration, drug characteristics, and reason for the shortage. RESULTS: From 2001 to 2022, 71 drug shortages for code cart medications were reported. The number of new shortages peaked in 2010, and the number of total shortages peaked in 2010. At the end of the study period, 61 (84.7%) shortages had been resolved. For resolved shortages, the mean shortage duration was 18.2 months. The drug with the greatest number of reported shortages was dextrose (10 total), the drug with the longest resolved shortage was calcium chloride injection (116 months), and the drug with the longest active shortage was atropine injection (165 months at the end of the study period). Throughout the entire study period, only 2 suppliers provided commercially available prefilled syringes of dextrose for stocking on code carts. The most common reason for shortages, when reported, was manufacturing delays. CONCLUSION: Medications commonly used in code carts were frequently impacted by drug shortages, which have the potential to impact patient care. Institutional protocols for mitigation and larger efforts to promote a more resilient drug supply chain are critical to ensure patient safety and quality care.

Medicines Shortages Reporting Systems (MSRS): An exploratory review of access and sustainability.

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.

Understanding drug exceptional access programs (DEAPs) in Canada, and their associated social and political issues.

Drug exceptional access programs (DEAPs) exist across Canada to address gaps in access to pharmaceuticals. These programs circumvent standard procedures, raising epistemic, economic, social and political issues. This commentary provides insights into these issues by revealing the context and procedures on which these programs depend.

Blockchain technology: A potential tool for the management of pharma supply chain.

BACKGROUND: The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to the product's complexity and transaction flows, an efficient traceability system is needed in the pharma supply chain to identify the current and all previous product owners. Digitizing the track and trace process significantly improves regulatory oversight and guarantees product quality. A distributed platform for shared data that is immutable, trustworthy, accountable, and transparent in the pharmaceutical supply chain could be built using blockchain-based drug traceability. OBJECTIVE: This review aims to shed light on blockchain technology's significance and necessity for pharmaceutical supply chain management systems. METHOD: A comprehensive literature review was performed between January 2017 and September 2023. The search was conducted to elaborate on blockchain technology. Blockchain is a software-based technology that logs and records transactions using a block structure arranged chronologically. Cryptography technology links and secures these blocks on a peer-to-peer network. Blockchain is anticipated to transform the pharmaceutical supply chain by giving all participants access to a single, straightforward system that provides transparency, security, and oversight of the end-to-end delivery of goods. RESULT: In all, various literature data were included in this review. Using a supply chain powered by blockchain has many benefits. To begin with, it gives a thorough account of the entire procedure from start to finish. A single piece of software can manage the entire supply chain. Additionally, it increases communication between parties with permission. The enhanced security and traceability that blockchain offers is another important benefit. A blockchain system can track, trace, and recall products. CONCLUSION: Blockchain-based pharmaceutical supply chain management enables the tracking of medicinal drug transactions from raw materials suppliers to end consumers. The pharma blockchain has the potential to enhance the security, integrity, data provenance, and functionality of the supply chain due to its transparency, immutability, and auditability.