• Antibiotic shortages
• Antibiotic stewardship
• Bacterial infection
• Supply chains
• Systematic

• Anti-Bacterial Agents/supply & distribution
• Humans

• Health Logistics Management Center, Ministry of Social Development, Bagmati Province

• Availability
• Disruption
• Drug shortage
• Pharmaceutical
• Stock-out
• Supply

• Humans
• Pandemics
• COVID-19
• Costs and Cost Analysis
• Policy
• Pharmaceutical Preparations

• Drug shortage
• Financial crisis
• Management
• Medication
• Validation

• COVID-19
• community pharmacists
• drug shortages
• patient care

• Epidemiology
• Health policy
• ONCOLOGY
• PUBLIC HEALTH

• Humans
• Pakistan
• Cross-Sectional Studies
• Pharmacists
• Bleomycin
• Carboplatin

• National Natural Science Foundation of China

• Actor levels
• Centralized shortage management
• Drug shortages
• Hospital pharmacy
• National task force
• Patient safety

• Europe
• availability
• medical need
• pandemic
• pharmaceutical preparations
• register
• stock-out
• supply chain

• Organization and Administration
• Quality of Health Care
• Safety
• Thromboembolism

• Anticoagulants/supply & distribution

• antibiotic shortages
• antibiotic use
• antimicrobial stewardship
• point-prevalence survey
• quality indicator

• Saudi Arabia
• ambulatory care
• drug class
• medication shortage
• perception
• pharmacist

• essential medicines
• market characteristics
• supply chain

• COVID-19/epidemiology
• Communicable Disease Control
• Cross-Sectional Studies
• Health Expenditures
• Humans
• Pharmaceutical Preparations
• Retrospective Studies
• Switzerland
• COVID-19 Drug Treatment

Patient access to medicines in the community at end-of-life (pertaining to the last year of life) is vital for symptom control. Supply of such medicines is known to be problematic, but despite this, studies have failed to examine the issues affecting community pharmacy access to palliative medicines.

To identify community pharmacists' and pharmaceutical wholesalers'/distributors' views on supply chain processes and challenges in providing access to medicines during the last year of life, to characterise supply in this UK context.

Qualitative design, with telephone interviews analysed using Framework Analysis. Coding frames were developed iteratively with data analysed separately and then triangulated to examine differences in perspectives.

Thirty-two interviews (24 community pharmacists and 8 wholesalers/distributors) were conducted. To ensure appropriate palliative medicines were available despite occasional shortages, community pharmacists worked tirelessly. They navigated a challenging interface with wholesalers/distributors, the Drug Tariff to ensure reimbursement, and multiple systems. IT infrastructures and logistics provided by wholesalers/distributors were often helpful to supply into community pharmacies resulting in same or next day deliveries. However, the inability of manufacturers to predict operational issues or accurately forecast demand led wholesalers/distributors to encounter shortages with manufactured stock levels, reducing timely access to medicines.

The study identifies for the first time how palliative medicines supply into community pharmacy, can be improved. A conceptual model was developed, illustrating how influencing factors affect responsiveness and speed of medicines access for patients. Work is required to strengthen this supply chain via effective relationship-building and information-sharing, to prevent patients facing disruptions in access to palliative medicines at end-of-life.

Drug shortages continue to pose a significant threat to public health and safety. Drug shortages not only worsen patient outcomes, but also significantly burden healthcare systems with additional costs. This study aimed to assess community pharmacy staff knowledge, opinion, and practice toward drug shortages in Saudi Arabia from November 2019 to March 2020. This was a cross-sectional study carried out among 1,008 community pharmacists from Saudi Arabia using a validated, self-administered and Internet-based survey. Analysis was done using chi square and fisher exact tests. Most participants were males (97.2%), less than 30 years old (48.1%), and non-Saudi citizens (94.4%), and 72.0% had good knowledge of drug shortages (score = 4–5). Around 36.0% reported that it takes 1–3 days to receive a response to the shortage report. There was a statistically significant association between the professional level of the community pharmacists and their opinion about reporting drug shortages (P < .05). Most community pharmacies (56.2%) did not receive any notification about drug shortages. In conclusion, most community pharmacists are knowledgeable and have good practice regarding drug shortages, but their opinions about drug shortages differ according to each pharmacy reporting policy.

• Drug shortage
• Knowledge
• Perception
• Pharmacist
• Saudi Arabia

• general medicine (see internal medicine)
• health policy
• health services administration & management
• quality in health care

• Cross-Sectional Studies
• Delivery of Health Care
• Humans
• Pakistan/epidemiology
• Patient Care
• Pharmacists

• Department of Science and Technology of Shaanxi Province
• National Natural Science Foundation of China

Background: The increasing number of drug shortages (DSs) worldwide calls for more proactive solutions to prevent the negative impacts of DSs on patient care. Such solutions require in-depth knowledge about potential patient safety risks related to DSs, the processes of recognizing and managing DSs, the contextual setting in which DSs occur, and the actors involved.

Objective: The aim of the study is to use prospective risk assessment to identify patient safety risks in hospitals associated with the management of DSs among actors at national, regional and local level in Denmark.

Methods: Healthcare Failure Mode and Effect Analysis (HFMEA) was employed in composition with elements from the Systematic Human Error Reduction and Prediction Approach (SHERPA) and the Systems-Theoretic Accident Model and Processes (STAMP). Potential risks related to DS management across three actor levels (national, regional and local) in the Danish healthcare system were described. Each actor level consisted of six participants that were identified using a purposive sampling strategy. Processes and sub-processes related to managing critical DSs were outlined and the actors identified, prioritized and rated potential failure modes, causes and consequences related to the processes. Recommendations to mitigate failures were proposed for high risk failures modes.

Results: Overall, a total of 167 failure modes were identified across the three actor levels. At the national level, the process of DS management consisted of 17 sub-processes, from which 71 failure modes were identified. Nine of them were rated as high risk. At regional level, 7 sub-processes and 33 failure modes were identified, of which 9 were rated as high risk. At local level, 14 sub-processes and 63 failure modes were identified, of which 32 were rated as high risk. The high-risk failures were related to a lack of IT support in the medication modules, underestimation of patient safety aspects, and insufficient personnel training and patient information.

Conclusion: Exploring DS management failure modes across actor levels provided an overview of interrelated failures. Potential solutions related to high risk failures were developed to ensure that actors ensure patient safety related to DS in healthcare.

•

Healthcare Failure Mode and Effect Analysis (HFMEA) is used to identify patient safety risks in hospitals associated with DS management among actors at national, regional and local level.

The shortage of medicines represents a complex global phenomenon that triggers patient care and safety issues. The study was undertaken to explore the impact of medicines shortages on patients in Pakistan. The study also identified barriers which hinder the solutions of medicines shortages issue.

A qualitative study design was adopted and the data was collected in stages between July and September 2019using an in-depth interview approach. The purposive and convenient sampling strategy was used to recruit the study participants. Sample size was limited by using the saturation point criteria. All interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis.

A total of 35 stakeholders including 13 physicians, 12 pharmacists and 10 patients participated in the study. The findings of the study were classified into five key themes and seven subthemes. The five themes included, ‘impact of medicine shortages on patients’, ‘patients’ practices in response to medicine shortages’, ‘influence of medicines shortages on medical practice or pharmaceutical business’, ‘barriers to solutions for medicines shortages’, and ‘suggestions to assuage the impact of medicine shortages.’This study showed that the medicine shortages had significant clinical and financial impact on patients. Patients’ opted for a number of risk-prone practices to avoid treatment disruption during shortages. An array of pharmaceutical market, medicines quality and patient related factors refrain physicians to switch from brand name medicine to generics and lead to ineffective management of medicines shortages. Promotion of generic prescription, implementation of punitive policies and proper patient consultation was advised to assuage the impact of medicine shortages on patients.

The adverse clinical, economic and humanistic impact affirmed in this study demand the introduction of risk-management strategies for medicines shortages in hospital and community settings in accordance with the international standards. Promotion of effective patient counselling by the healthcare professionals to deter risk-prone practices associated with medicines shortages is mandatory.

The online version contains supplementary material available at 10.1186/s12913-021-06812-7.

• Access to medicines
• Drug regulatory Authority of Pakistan
• Essential medicines
• Generic substitution
• Impact
• Medicines shortages

• COVID-19
• Critical Care
• Drugs
• Global Health
• Intensive Care Unit

• causes
• definitions
• drug shortage
• impacts
• medicine shortage
• mitigation strategies

Given the impact of politico-economic sanctions on the pharmaceutical supply chain, this study aims to identify practical strategies to improve the resilience of the Iranian supply chain in pharmaceutical procurement under politico-economic sanctions.

This is a qualitative content analysis study conducted in 2018. Semi-structured interviews were conducted using snowball sampling, and saturation was achieved after 18 interviews. Guba and Lincoln's criteria, namely credibility, confirmability, transferability, and dependability, were considered to ensure the validity and transparency of the study. A five-step framework analysis was applied to analyze the data using MAX QDA10.

The results led to the identification of nine main themes and 26 subthemes as strategies to improve the resilience of the pharmaceutical chain. According to the thematic map, some of these strategies have an extra-sectoral character: ‘insurance organizations’, ‘strengthening relations with other countries’, ‘mechanization of the distribution system’, and ‘suppliers and manufacturers’. At the same time, some inter-sectoral strategies can help the pharmaceutical chain maintain its resilience: ‘healthcare management and policy’, ‘exploiting local potential’, ‘pricing’, and ‘integrated health information systems.’ As a strategy, ‘Medical community and consumers’ also plays a crucial role in this regard. According to the subthemes, revisions of health management, more supervision, privatization, clinical policies, strategic purchasing, improvement of the referral system, inter-sectoral cooperation, support of indigenous medicines, rational pricing, insurance system, improvement of medical coverage, and development of electronic prescription should be considered by health systems. Sufficient support for indigenous medication and supervision of the distribution system should be considered by the pharmaceutical industry, taking into account the cooperation between consumers and patients.

Integration of the pharmaceutical supply chain and modern technologies, more attention to business complexity, economic development, intense competition, rapid changes in customer needs, and appropriate relationship between manufacturers, distributors, prescribers, and insurance organizations as purchasers should be considered by policymakers to improve supply chain resilience.

• Iran
• Pharmaceutical supply chain
• Politico-economic sanctions
• Qualitative content analysis
• Resilience
• Strategy

• Denmark
• Drug shortage
• Hospital
• Management and communication
• Qualitative research
• Social constructivism

Drug shortage is a significant public health problem, especially for drugs related to life threatening conditions. Almost all countries affected by variety of supply problems and spent a considerable amount of time and resources responding to shortage. The aim of present study is to determine and prioritize strategies to achieve best solutions for these considerable healthcare system challenges and to evaluate this strategies base on practical criteria.

To achieve the study objectives, the research was conducted in two phases. Determining of the strategies to control drug shortage, and comprehensive assessments of priority of possible strategies. For each phase, a self-design questionnaire was developed. The five main managerial strategies dimensions including: regulatory, financial, supply chain, information system and policy-making were set out. Forty-five alternatives were elicited from literature, and were evaluated and trimmed to 37 strategies based on experts’ opinion. The Multiple criteria decision-making (MCDM) methods were applied in second phase. Five important criteria including cost, time, labor, compliance with law and culture were weighed by Analytic Hierarchy Process (AHP) technique. Then, 37 alternatives have been rated base on the five criteria on the Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) technique.

“Creating integrated Supply chain information system to manage medicines inventory in the country”, “Creating and using the databases to predict the shortage of medicines”, “Using track and trace system” are alternatives 20th, 24th and 25th, which related to supply chain (SC) and information system (IS) dimensions have higher priority in the experts’ point of view. The results show IS dimension has 100 percentage of priority; following that policy and supply chain have higher priority, respectively.

Health systems rely on consistent supplying of pharmaceuticals to support patient care. The results show that information system, policy-making and supply chain are in the top-ranking priorities. Warning system needs to be improved to the advance system via better collaboration with stakeholders, publish precise and explicit national guidelines for drug shortage management, enforce the guidelines, and improve Iran FDA’s pharmaceutical market control capability.

• Drug shortage
• Iran
• Multi-criteria decision-making
• Pharmaceutical policy
• Supply chain management

• COVID-19
• antimicrobial resistance
• epidemiology
• global health

• Anti-Bacterial Agents/supply & distribution
• Anti-Bacterial Agents/therapeutic use
• COVID-19/epidemiology
• COVID-19/prevention & control
• Communicable Disease Control/methods
• Communicable Disease Control/organization & administration
• Critical Pathways/organization & administration
• Critical Pathways/trends
• Drug Resistance, Bacterial/physiology
• Global Health/trends
• Humans
• SARS-CoV-2
• COVID-19 Drug Treatment

• MR/P014658/1 Medical Research Council
• NIHR Policy Research Program through its core support to the Policy Innovation and Evaluation Resear National Institute for Health Research
• TB MAC OPP1135288 Bill and Melinda Gates Foundation
• LID Studentship (MR/N013638/1) Medical Research Council
• Skills Development Fellowship (MR/P014658/1) Medical Research Council
• London Interdisciplinary Doctoral Programme (BB/M009513/1) Biotechnology and Biological Sciences Research Council
• 874850 H2020 European Research Council

Among increasingly common drug shortages, antimicrobial drug and vaccine shortages are the most frequently reported. This could be related to the smaller size of the market, compared to statins or antidepressant drugs. But there are multiple causes to shortages, such as flawed manufacturing processes, modification of quality control processes and scarcity of raw materials. Besides, concentration of manufacturing in emerging economies, dependence on a single producer and pressure on profit margins amplify the consequences of any manufacturing problem. Antimicrobial drug shortages have an impact on patient outcomes and antimicrobial resistance (AMR) by leading to choices of alternatives with an inadequately large spectrum, and consequently with deleterious side effects and increased costs. Moreover, vaccine shortages result in controversies exacerbated by the antivax community. Given the transmissibility of infectious diseases, antimicrobial drug and vaccine shortages will impact both individual and population health through herd effect. For these reasons, they represent a worldwide threat that goes beyond impact at the individual level. There has been no coordinated response to this threat hitherto. In order to provide an adequate response plan, precise data on shortage occurrences and their causes are a prerequisite. Moreover, efficient action will not be possible without a transnational will. Examples of useful actions could be: Incorporating a standardized survey into the WHO surveillance programs on antimicrobial use; creating a communication channel between pharmaceutical companies, providers and national agencies so as to recognize upcoming shortages; licensing some laboratories to manufacture out-of-stock drugs, for the duration of the shortage.

• antimicrobial
• antimicrobial resistance
• out-of-stock
• shortage
• vaccine
• vaccine hesitancy

Objectives: The primary objective of the study was to assess the impact of the Low-Price Medicine Policy (LPMP) on the supply of low-price medicines (LPMs) in China. The secondary objective of the study was to describe the supply situation of LPMs from 2005 to 2018.

Methods: The LPMP was launched in the third quarter of 2014 (2014Q3). An interrupted time series analysis was used to evaluate the impact of LPMP on the supply of LPMs in China. Ordinary least squares and Poisson regression models were utilized to estimate the effect of LPMP on LPMs’ supply growth rate and the number of supplied LPMs. All the LPMs were divided into two subgroups: intermittent supply and continuous supply. The trend and level changes of the quarterly average growth rate and number of quarterly supplies for different LPM groups were analyzed from 2005 to 2018.

Findings: For the quarterly average growth rate, before the intervention, a significant increasing trend was observed in the total group and the continuous supply subgroup; after the introduction of LPMP, the increasing trend was ceased and a significant decrease in the trend and level was noted for both the total group (trend coefficient: β₃= −0.0132, p < 0.01; level coefficient: β₂ = −0.1510, p < 0.05) and the continuous supply subgroup (trend coefficient: β₃ = −0.0133, p < 0.01; level coefficient: β₂ = −0.1520, p < 0.05); whereas it had no significant effect for intermittent supply subgroup. For the number of quarterly supplies, after the intervention of LPMP, decline of the supply number was observed (trend coefficient: β₃ = −0.0027, p < 0.001; level coefficient: β₂ = −0.0584, p < 0.001); whereas the LPMP was associated with an upward trend and level (trend coefficient: β₃ = 0.0715, p < 0.001; level coefficient: β₂ = 0.174) for the intermittent supply subgroup.

Conclusion: For most of the LPMs, LPMP did not meet the goal of stimulating LPM production. However, for severely shortage medicines (the intermittent supply subgroup), the effect of LPMP was positive. Comprehensive policies rather than just deregulating medicine price should be introduced to alleviate the situation of medicine shortage in China.

• interrupted time series analysis
• low‐price medicine policy
• medicine price
• medicine shortage
• medicine supply

Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe.

Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code.

Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment.

Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.

• Europe
• antibiotics
• medicine shortage
• mitigation
• prospective risk assessment
• substitution

The present study aimed to develop an Analytic Network Process (ANP) model to assist policymakers in identifying and prioritizing allocation indicators, which are being used or should be used to distribute drugs in short supply among different provinces.

The model encompasses the interactions between various indicators and efficiency, equity, and effectiveness paradigms. Accordingly, a set of clusters and elements, which were associated with the allocation of drugs in short supply in Iran’s pharmaceutical system, were detected to develop the model and were then compared in pairs in terms of a specified factor to show the priorities.

Equity had the highest priority (0.459) following by Efficiency (0.37), and Effectiveness (0.171). The 4 most important allocation indicator were “number of prescriptions” (0.26) and “total bed occupancy rate” (0.19) related to equity, “total population” (0.21) in efficiency and “the burden of rare and incurable disease” (0.07) in effectiveness paradigm.

The capability to overcome inefficient resource allocation patterns caused by both oversupply and undersupply derived from historic resource allocation may be highly limited in the absence of the need indicators. The quality of the decision is related to a careful balancing act of the three paradigms which represents roughly the triple aim of public healthcare systems: clinical improvement (effectiveness), population health improvement (equity and access), and reducing cost (economic aspects -efficiency).

• Analytic network process
• Effectiveness
• Efficiency
• Equity
• Need-based resource allocation
• Resource allocation
• Scarce drugs allocation

Coronavirus disease 2019 (COVID-19) arising from Wuhan, China, is currently outbreaking worldwide. The World Health Organization (WHO) has declared COVID-19 to be a global pandemic. COVID-19 could cause a wide range of symptoms ranging from self-limiting fever, sore throat, and cough to more severe symptoms that could lead to acute respiratory distress syndrome. As a result of the lockdown and increased demand, drug shortages could become a growing global issue. This article aims to shed light on the potential impact of drug shortages as a result of this pandemic on patient outcomes and the role of pharmacists and pharmacy policymakers in alleviating this emerging problem.

• COVID-19
• Coronavirus
• Drug shortage
• Pandemic
• Pharmacist
• Policymaker

Drug shortages are common yet their impact on patient care and their commercial ramifications has not been adequately researched. In Australia a shortage of balsalazide (2012-2013) necessitated substitution with alternative 5-aminosalicylate (5-ASA) formulations for ulcerative colitis (UC).

To assess and compare the clinical and commercial sequelae of non-medical switching from balsalazide to another 5-ASA and/or return to balsalazide once supply resumed.

A prospective cohort study of patients on balsalazide for mild-moderate UC was conducted where, strictly due to the national shortage (November 2012- January 2013), were switched to alternative 5-ASA and/or then returned to balsalazide once supply resumed. Clinical (Partial Mayo), endoscopic (Mayo score) activity, adverse effects (to alternative 5-ASA) and percentage market share (of continuous 5-ASA users) from baseline (i.e., time of switching due to shortage) through to five years were assessed.

Of 31 patients switched due to the shortage, 12 (38.7%) resumed balsalazide immediately once supply resumed, 8 (25.8%) prompted by adverse effects to the alternative 5-ASA used. Three patients (9.7%) had documented symptomatic improvement, 15 (48.4%) were unchanged and 13 (41.9%) had symptomatic worsening vs baseline (P < 0.01), after switching to an alternative 5-ASA. At 3 and 5y post switch, overall 26/31 (83.9%) and 23/31 (74.2%) had remained continuously on any 5-ASA therapy respectively. Twelve (38.7%) and 11 (35.5%) patients remained on balsalazide continuously at three and five years respectively after drug supply returned, equating to a loss of market share (within 5-ASA class) of 45.2% and 38.7% respectively.

This study of a balsalazide shortage in UC patients exemplifies the detrimental impact of a drug shortage on long term patient, disease and commercial outcomes.

• Inflammatory bowel disease
• Ulcerative colitis
• Drug supply
• Drug shortage
• Patient outcomes
• Market share

• Europe
• medicine shortage
• mitigation strategy
• risk assessment
• substitution

• France
• drug shortages
• major therapeutic interest
• national reporting system
• pharmacosurveillance
• short supply
• supply of medicines

• Databases, Factual
• Drugs, Generic/supply & distribution
• France
• Humans
• Prescription Drugs/classification
• Prescription Drugs/supply & distribution
• Retrospective Studies

The United States has experienced prolonged severe shortages of vital medications over the past two decades. The causes underlying the severity and prolongation of these shortages are complex, in part due to the complexity of the underlying supply chain networks, which involve supplier-buyer interactions across multiple entities with competitive and cooperative goals. This leads to interesting challenges in maintaining consistent interactions and trust among the entities. Furthermore, disruptions in supply chains influence trust by inducing over-reactive behaviors across the network, thereby impacting the ability to consistently meet the resulting fluctuating demand. To explore these issues, we model a pharmaceutical supply chain with boundedly rational artificial decision makers capable of reasoning about the motivations and behaviors of others. We use multiagent simulations where each agent represents a key decision maker in a pharmaceutical supply chain. The agents possess a Theory-of-Mind capability to reason about the beliefs, and past and future behaviors of other agents, which allows them to assess other agents’ trustworthiness. Further, each agent has beliefs about others’ perceptions of its own trustworthiness that, in turn, impact its behavior. Our experiments reveal several counter-intuitive results showing how small, local disruptions can have cascading global consequences that persist over time. For example, a buyer, to protect itself from disruptions, may dynamically shift to ordering from suppliers with a higher perceived trustworthiness, while the supplier may prefer buyers with more stable ordering behavior. This asymmetry can put the trust-sensitive buyer at a disadvantage during shortages. Further, we demonstrate how the timing and scale of disruptions interact with a buyer’s sensitivity to trustworthiness. This interaction can engender different behaviors and impact the overall supply chain performance, either prolonging and exacerbating even small local disruptions, or mitigating a disruption’s effects. Additionally, we discuss the implications of these results for supply chain operations.

• Computer Simulation
• Decision Making
• Equipment and Supplies, Hospital/trends
• Humans
• Models, Organizational
• Pharmaceutical Preparations/economics
• Pharmaceutical Preparations/supply & distribution
• Trust/psychology
• United States

• The National Science Foundation

• brand medicines
• drug regulatory authority of Pakistan
• drug shortage
• pricing
• short medicines

• Drug Industry/legislation & jurisprudence
• Drug Industry/organization & administration
• Drug Industry/standards
• Government Regulation
• Health Services Needs and Demand
• Humans
• Pakistan/epidemiology
• Pharmaceutical Preparations/economics
• Pharmaceutical Preparations/supply & distribution
• Qualitative Research
• Quality Control

Introduction: Over the last decade, global health policies and different research areas have focused on the relevance and impact of medicine shortages. Published studies suggest there have been difficulties with access to medicines since the beginning of the 20th century, and there have been advances in our understanding and management of the problem since then. However, in view of global and regional health care concerns with shortages, we believe this phenomenon needs to be characterized and described more fully regarding the types of medicines affected, possible causes, and potential strategies to address these. The aim of this scoping review was to identify, compare if possible, and characterize the recent literature regarding the situation of medicines shortages between countries, and provide different perspectives, including a global context and national approaches.

Methodology: A scoping study presented as a narrative review of the situation and findings principally based on published articles.

Results: Based on the reported cases in the literature, a typology of medicines shortage and supply interruption episodes and their causes were proposed; national approaches to notify and manage the medicines shortages cases were described and classified by update frequency; principal differences between market and supply chain management perspectives of the situation were identified and global and countries’ perspectives were described.

Conclusion: Policy makers require solutions that prevent those cases in which the population’s health is affected by episodes of medicine shortages and/or interruption in the supply chain. There is also a need to generate a glossary related to logistics management and the availability of medicines which will be useful to understand and overcome shortages. In addition, recognize that potential solutions are not only related with actions linked to research, development and innovation, but much wider. Overall, we believe this article can act as a basis for future discussions in this important area.

• Europe
• North America
• South America
• Western Asia
• medicine access
• medicine shortages
• medicine supply
• pharmaceutical policy

Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting.

Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held.

The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety.

DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

• drug change
• drug shortage
• facilitators and measures
• hospital
• patient safety challenges
• tender

• Humans
• Patient Outcome Assessment
• Pharmaceutical Preparations/supply & distribution
• Treatment Outcome

• Drugs
• Patient safety
• Shortage