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812,329 result(s) for "Shortage"
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2SPD-025 Application of hazard vulnerability analysis to evaluate the risk level of medicine shortages
Background and importanceDrug shortages have become a worldwide phenomenon which has repercussions on patient care and on the hospital’s budget.Aim and objectivesThe aim of our study was to assess the risk of shortages of drugs included in our hospital therapeutic formulary (HTF), for which there is shortage reporting, using a hazard vulnerability analysis (HVA).Material and methodsWe performed an HVA on 43 drugs in our HTF, which were also included in the Italian Medicines Agency list of shortages. The HVA used to assign the risk of shortage (ROS) included three macro areas: probability that the shortages will occur based on shortages in the past 2 years; magnitude factors which increase the risk of shortages; and mitigation factors which reduce it. Probability was assigned a score from 0 to 2 based on previous shortages.Magnitude factors wererelevance of active substance; budget impact; and percentage of patients treated. Mitigation factors were: therapeutic alternative; stock availability; and import of drug. For each of these items a score from 0 to 3 was assigned. For magnitude factors, a higher score was assigned for increasing severity values. In contrast, for mitigation factors, a higher score was assigned in relation to mitigation reduction. The value of the risk was calculated multiplying the percentage of probability (P) and the percentage of severity (S). According to the score obtained, three classes of ROS were assigned: low (<30%); medium (30–60%); and high (>60%).ResultsNo drug was found to be at high risk of shortage (>60%), 32/43 (74.4%) were at low risk of shortage and 11/43 (25.6%) were at medium risk of shortage. The latter had previously been lacking; 6/11 had the same active ingredient as a therapeutic alternative, 3/11 had a different active ingredient as an alternative while 2/11 had no alternative.Conclusion and relevanceThe HVA is an important method to assess the ROS and implement targeted strategies for drugs at risk of shortages. Knowledge of the risk level facilitates the timeliness of the interventions to resolve the shortages themselves.References and/or acknowledgementsNo conflict of interest.
Drug Shortage: Causes, Impact, and Mitigation Strategies
Drug shortage is a global issue affecting low, middle, and high-income countries. Many countries have developed various strategies to overcome the problem, while the problem is accelerating, affecting the whole world. All types of drugs, such as essential life-saving drugs, oncology medicines, antimicrobial drugs, analgesics, opioids, cardiovascular drugs, radiopharmaceutical, and parenteral products, are liable to the shortage. Among all pharmaceutical dosage forms, sterile injectable products have a higher risk of shortage than other forms. The causes of shortage are multifactorial, including supply issues, demand issues, and regulatory issues. Supply issues consist of manufacturing problems, unavailability of raw materials, logistic problems, and business problems. In contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal demand, and unpredictable demand. For regulatory issues, one important factor is the lack of a unified definition of drug shortage. Drug shortage affects all stakeholders from economic, clinical, and humanistic aspects. WHO established global mitigation strategies from four levels to overcome drug shortages globally. It includes a workaround to tackle the current shortage, operational improvements to reduce the shortage risk and achieve early warning, changes in governmental policies, and education and training of all health professionals about managing shortages.
National and transnational drug shortages: a quantitative descriptive study of public registers in Europe and the USA
Background Drug shortages are a growing global problem, posing clinical and economic challenges. To understand them better, we conducted an inventory of national public drug shortage registers and their comparability in Europe and the USA. Methods The study was based on openly accessible drug shortage notifications published by national drug authorities. These data were obtained from all national data sources mentioned on the European Medicines Agency’s (EMA’s) web page and FDA in the USA. After selection of the countries with comparable data, descriptive statistics were used to present characteristics of the shortages both across countries and within countries for 9 months (January–September) in 2020. We studied whether the shortages that occurred in these countries were the same, and how shortages were distributed by therapeutic uses and formulations. We also investigated price variation between the United States and Finland among drugs in shortage in one formulation category (creams and gels). Results Finland, Sweden, Norway, Spain, and the United States had suitable registers and were included. Altogether 5132 shortage reports from Finland ( n  = 1522), Sweden ( n  = 890), Norway ( n  = 800), Spain ( n  = 814), and the United States ( n  = 1106) were published during the study period. Of active ingredient level shortages 54% occurred in only one country, and 1% occurred in all five. However, at the country level, where there was one or more shortage notifications in an ATC active ingredient category, 19–41% were in a single country. The distributions by ATC therapeutic class and drug formulation differed substantially between countries, particularly between the USA and European countries. Injectables had a high shortage risk in the USA (57% of all shortages versus 17–31% of all shortages in the European countries). By contrast, shortages in gels and creams occurred only in European data (4–6% of all shortages). In the price comparison, creams and gels in shortage in Finland were 160% more expensive in the USA where these shortages were not detected. Conclusions Public drug shortage registers are vital data sources for proactively maintaining and managing a reliable drug supply. However, our study demonstrates that much work remains to standardize the contents and quality of public register data. Shortages may not be solely a consequence of manufacturing disruptions but may reflect other contributing factors in the international drug distribution and supply mechanisms, including price differences and profit margins between national pharmaceutical markets. Data to perform practical and useful international comparisons to understand these shortages are required.
Remembering the 1970s gas shortages that wreaked national havoc
The sudden fuel shortage isn't the first time Americans have endured long lines and high gas prices.
DD-026 New market for medicines: Do the suppliers meet their commitments?
BackgroundPurchasing procedures in hospital are subject to the public procurement code and vary with the amounts of the purchase. The tender must be implemented when the purchase amount exceeds 200 000 Euros HT during the contract period. Although suppliers tender on estimated quantities, sometimes laboratories do not fulfil the first orders.PurposeThe objective of this study was to analyse the proportion of new markets whose orders were not honoured in the first 3 months after the beginning of the market.Material and methodsThe study focused on the local tender for generics starting in July 2015. The number of molecules for which the suppliers changed compared with the previous market were listed. The number of molecules for which the orders were not met by the contract holders in the first 3 months were also listed. Then we analysed the causes of these stock shortages. We also recorded if the upholder of the market was the best bidder or not, and if the previous market was subject to drug shortages or not.ResultsThe local market included 111 market changes. The proportion of new markets whose orders were not honoured in the first 3 months was 10%. 82% of these stock-outs concerned generics. 5 different suppliers were concerned, including 4 generic manufacturers. In 82% of cases, the successful supplier was the best bidder. 4 different causes of drug shortages were reported, the most common was a problem of quality control of raw material. In 18% of cases. the previous market was also subject to stock-outs.ConclusionDrug shortages on new markets are significant, and they may impact on quality of patient care and are time consuming for teams managing stock-outs (calls to other suppliers, orders, etc). It would be interesting to quantify the management cost of a drug shortage (human time, financial cost) and to establish indicators for the performance of suppliers that could help in the choice of future tenders.References and/or AcknowledgementsDirective 2004/18/EC of the European Parliament and of the Council of 31/03/2004 on the coordination of procedures for the award of public contracts.No conflict of interest.
Drug shortage in South Korea: machine learning-based prediction models and analysis of duration and causal factors
Drug shortages remain a critical challenge for healthcare systems in South Korea. This study aimed to develop predictive models to forecast drug shortage duration and identify their underlying causes. Using 1,054 regulatory-reported drug shortage cases from 2018 to 2024 obtained from the Korean Ministry of Food and Drug Safety (KMFDS), we developed two machine learning models: (1) Model 1 to estimate shortage duration ranges, and (2) Model 2 to classify shortage causes into seven categories. Eighteen features related to drug shortages were included based on relevance and data availability. Key predictors were identified using Random Forest feature importance. Model 1 achieved an accuracy of 62%, with Shortage Incidence Frequency being the most influential variable (importance = 0.152). In Model 2, weighted precision, recall, and F1-score all exceeded 70%, indicating robust performance despite imbalanced class distributions. The most important predictors for cause classification included Shortage Incidence Frequency, Existence of alternative drugs with the same ingredient, and Business size of the Marketing Authorization Holder. The KMFDS should continuously monitor drugs with repeated shortage episodes through regular reporting, early-warning systems, and supply-risk assessments. Incorporating supply-side indicators-particularly those related to economic feasibility-into national surveillance programs may help prevent shortages and mitigate their duration. By identifying key predictors associated with shortage causes, this study provides evidence to guide policy prioritization and targeted interventions.
Efficient hydrogen production from wastewater remediation by piezoelectricity coupling advanced oxidation processes
Efficient H₂ harvesting from wastewater instead of pure water can minimize fresh water consumption, which is expected to solve the problem of water shortage in H₂ production process and contribute to carbon neutrality in the environmental remediation, but the inevitable electron depletion caused by electron-consuming pollutants will result in an exhausted H₂ evolution reaction (HER) performance. In this paper, by coupling piezocatalysis and advanced oxidation processes (AOPs) by a MoS₂/Fe⁰/peroxymonosulfate (PMS) ternary system, extensive types of wastewater achieved considerable H₂ generation, which exceeded the yield in pure water with synchronous advanced degradation of organic pollutants. In addition, profiting from the crucial bridging role of PMS, the H₂ yield in nitrobenzene wastewater after the introduction of PMS-based AOPs increased 3.37-fold from 267.7 μmol·g−1·h−1 to 901.0 μmol·g−1·h−1 because the presence of PMS both thermodynamically benefited MoS₂ piezocatalytic H₂ evolution and eliminated the electron depletion caused by organic pollutants. By this way, the original repressed H₂ evolution performance in substrate of wastewater not only was regained but even showed a significant enhancement than that in pure water (505.7 μmol·g−1·h−1). Additionally, the cyclonic piezoelectric reactor was preliminarily designed for future industrialization. This strategy provided a valuable path for the recycling of actual wastewater by fuel production and synchronous advanced treatment.