Impact of medicine shortages on patients - a framework and application in the Netherlands.
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ABSTRACT: Background
Medicine shortages are often described in plain numbers, suggesting all shortages have a uniform impact. However, some shortages have a direct and serious effect on patients and need a prompt reaction from stakeholders. This study aims to create a broad framework to assess the impact of a shortage.Method
We identified high impact shortages and selected exemplary shortages which we considered our learning cases. From five learning cases, we identified elements that had a potentially profound impact on one or more of these cases. We tested data saturation on the elements with another five test cases. Based on these elements, we created a framework to assess impact of shortages on patients and presented practical examples how to rate these different elements. Subsequently, we visualised the impact of these five learning cases on patients in radar charts.Results
The five elements which we identified as potentially having a large impact were 1) alternative product, 2) disease, 3) susceptibility, 4) costs and 5) number of patients affected. The five learning cases rated high on different elements, leading to diverse and sometimes even opposite patterns of impact.Conclusion
We created a framework for assessing the impact of a medicine shortage on patients by means of five key elements. By rating these elements, an indication of the impact can be obtained.
SUBMITTER: Postma DJ
PROVIDER: S-EPMC9670055 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Impact of medicine shortages on patients - a framework and application in the Netherlands.
Postma Doerine J DJ De Smet Peter A G M PAGM Notenboom Kim K Leufkens Hubert G M HGM Mantel-Teeuwisse Aukje K AK
BMC health services research 20221117 1
<h4>Background</h4>Medicine shortages are often described in plain numbers, suggesting all shortages have a uniform impact. However, some shortages have a direct and serious effect on patients and need a prompt reaction from stakeholders. This study aims to create a broad framework to assess the impact of a shortage.<h4>Method</h4>We identified high impact shortages and selected exemplary shortages which we considered our learning cases. From five learning cases, we identified elements that had ...[more]
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Project description:IntroductionCurrent research to assess the impact that medicine shortages have on patients is limited to general aspects, such as the prevalence of shortages and product characteristics. The aim of this study is to assess the overall impact that medicine shortages have on economic, clinical, and humanistic outcomes.MethodsA cohort of all known products in shortage in the Netherlands between 2012 and 2015 were characterized by their route of administration, anatomical therapeutic chemical class, and whether they were originator or generic products. A representative sample of 324 shortages (18% of all shortages) was rated as having low, medium, or high impact on the five elements that determine the impact of shortages on patients: availability of an alternative product, underlying disease, susceptibility of the patient, costs (for patients and society at large), and number of patients affected. Ratings were converted into numerical scores per element and multiplied to obtain an overall impact score.ResultsTwo elements were most frequently rated as having a high impact: disease (29%) and costs (20%). Nearly half of the shortages (47%) rated high on at least one element, while nearly 10% rated high on multiple elements. Thirty percent of the shortages rated high on direct impact, which is represented by these elements: alternative product and disease. An additional 17% of the shortages rated high on indirect impact, which is represented by these elements: costs, susceptibility, and number of patients. High impact scores could not significantly be attributed to characteristics of the products in shortage.ConclusionsAn assessment of the medicine shortages' impact using a framework based on economic, clinical, and economic outcomes showed that all three outcomes affect the overall impact that medicine shortages have on patients.
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Project description: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.
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Project description:Beaches are thought to be a large reservoir for marine plastics. To protect vulnerable beaches, it is advantageous to have information on the sources of this plastic. Here, we develop a universally applicable Bayesian framework to map sources of plastic arriving on a specific beach. In this framework, we combine Lagrangian backtracking simulations of drifting particles with estimates of plastic input from coastlines, rivers and fisheries. The advantage over traditional Lagrangian simulations is that the Bayesian framework can consider information on known sources, and thus facilitates spatiotemporal source attribution for plastic arriving at the specified beach. We show that the main sources for our target beach in southwest Netherlands are the east coast of the UK, the Dutch coast, the English Channel (fisheries) and the Thames, Seine, Rhine and Trieux (rivers). We also show that floating time is a major uncertainty in source attribution using backtracking.
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Project description:ObjectivesMedicine access is a human right; yet, concerningly, there are international instances of shortages. Quantitative data has allowed WHO to propose global solutions; however, individualised understanding of specific regions is still required to work towards national solutions. Fiji has an established issue with medication supply and the aim of this study was to use qualitative methods to gain a fuller understanding of this context.MethodsSemi-structured interviews were used to gain the perspective of key stakeholders involved in the Fijian medicine supply chain in regards to causes, impacts and possible solutions of medicine shortages. Thematic analysis was used to analyse the interview data.ResultsIn total, 48 stakeholders participated and the information was synthesised into three main themes, causes, impacts and solutions and the sub-themes including; political, system and patient causes, adverse health effects on patients, professional dissatisfaction, monetary loss and loss of faith in the health system, workarounds, operation improvements, government intervention and education and training.ConclusionsThe situation in Fiji is not dissimilar to other instances of shortages around the world and hence international solutions like that proposed by WHO are feasible; however, they must be modified to be uniquely Fijian to work in this context.
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Project description:BackgroundEarly identification is critical for mitigating the impact of medicine shortages on patients. The internet, specifically social media, is an emerging source of health data.ObjectiveThis 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.MethodsMedicine 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.ResultsOf 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.ConclusionsThe 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.
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Project description:Prescription drug shortages began to increase markedly in the mid-2000s, including sterile injectable products such as chemotherapy drugs. Using Medicare claims linked to Surveillance Epidemiology and End Results (SEER), we examined outpatient chemotherapy use during shortage periods relative to the months before and after a shortage for newly diagnosed patients with breast, colorectal, leukemia, lung, lymphoma, ovarian, or pancreatic cancer (N = 182,470). For most drugs, we found little impact of shortages on either the fraction of patients receiving that drug or the quantity provided. In some cases, we found declines in utilization: 4% for doxorubicin and fluorouracil; 2.9% for oxaliplatin; and about 1% for cytarabine, dacarbazine, and leuprolide. Although shortages for a few drugs resulted in substantial reductions in use, in most cases, they resulted in little to no reduction. We discuss potential explanations for these counterintuitive findings, including potential limitations of current drug shortage reporting methods.
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Project description: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.
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Project description:IntroductionWhile medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice.MethodologyA semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns.ResultsThe participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy.ConclusionThe study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.
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Project description:BackgroundThe 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.MethodsA 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.ResultsA 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.ConclusionThe 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.
| S-EPMC8369330 | biostudies-literature
Project description:ObjectivesThe study estimated the shortages of oncology medicines in Pakistan, their causes, impacts, mitigation strategies, and possible interventions.DesignCross-sectional survey.SettingOncology pharmacists working at 43 oncology settings (out of 80) from five regions of Pakistan (four provinces (Punjab, Sindh, Khyber Pakhtunkhwa and Baluchistan) and one federal territory (Islamabad)) were approached.ParticipantsOncology pharmacists with more than 1 year of experience were selected using stratified random sampling, and data were collected using a questionnaire from September 2021 to January 2022.Primary and secondary outcome measuresTo estimate the prevalence of oncology medicine shortages in Pakistan and establish recommendations to overcome them.ResultsOf 167 responded pharmacists, 87% experienced shortages in their practice. Most respondents (50%) experienced both oncology and support agent shortages. It was a current problem in hospitals (58%) and increased with time, but the situation varied across regions (p=0.007). Mainly shortages occur half-yearly (p=0.001) and last for <3 months. Injectable (56.8%) and branded drugs (44.9%) were short. The most frequently mentioned drugs affected by shortages were etoposide, paclitaxel, dacarbazine, bleomycin and carboplatin. Usually, distributors (51.5%) notify the pharmacists about the shortages, and federal agencies (36%) are responsible for these shortages. Distributors (53.4%) were the main source of supply, and shortages were encountered by them as well. The impacts included delayed care (25%) and suboptimal outcomes (23%) on patients, extra time (32%) for staff, prioritisation issues (31%) for pharmacists, delayed clinical trials (60.5%) and increased drugs prices (52.1%). Some hospitals have reporting systems (39.5%) and recording (29.3%) drug shortages. The shortages were managed using available alternative options (21%) and redistributing (21%) the currently available stock.ConclusionPakistan's healthcare system is affected by oncology medicine shortages. The government should establish a cancer registry and drug shortage platform, revise drug prescribing/pricing policies and practice penalties for breaching regulations. Oncology medicines must be widely available to avoid the grey market.
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