Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.327
Michael Ganio
This article argues that drug shortages should be addressed as crises that exacerbate already compromised US health care infrastructure. Clinicians, especially pharmacists, can help limit threats that shortages pose to patients. For example, pharmacists can canvass procurement options, consolidate inventory, and prepare medications to prevent need for some clinical interventions. This article describes how pharmacists' preparation and training equip them to help clinical teams navigate shortages by equitably rationing limited medicines, suggesting appropriate therapeutic alternatives, modifying drug administration routes, or delaying interventions. Pharmacists' roles can be key, since good management of supplies during drug shortages can mitigate risk of worse-than-usual clinical outcomes, mitigate risk of medication errors, and reduce some financial burdens on the overall health care system.
{"title":"How Should We Draw on Pharmacists' Expertise to Manage Drug Shortages in Hospitals?","authors":"Michael Ganio","doi":"10.1001/amajethics.2024.327","DOIUrl":"https://doi.org/10.1001/amajethics.2024.327","url":null,"abstract":"This article argues that drug shortages should be addressed as crises that exacerbate already compromised US health care infrastructure. Clinicians, especially pharmacists, can help limit threats that shortages pose to patients. For example, pharmacists can canvass procurement options, consolidate inventory, and prepare medications to prevent need for some clinical interventions. This article describes how pharmacists' preparation and training equip them to help clinical teams navigate shortages by equitably rationing limited medicines, suggesting appropriate therapeutic alternatives, modifying drug administration routes, or delaying interventions. Pharmacists' roles can be key, since good management of supplies during drug shortages can mitigate risk of worse-than-usual clinical outcomes, mitigate risk of medication errors, and reduce some financial burdens on the overall health care system.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"44 9","pages":"E327-333"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140767068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.295
Nisha Quasba, Elliot Vice
Drug importation raises several ethical and safety concerns relevant to prescribers and policy makers considering costs and benefits of international medicine importation. This article suggests key points to consider, especially from a policy perspective, when weighing imported medicines' perceived affordability and accessibility against additional resource expenditure needed to assure sufficient regulatory oversight and equitable distribution and to mitigate potential risks of harm to patients.
{"title":"What Should Prescribers and Policy Makers Know About US Drug Importation?","authors":"Nisha Quasba, Elliot Vice","doi":"10.1001/amajethics.2024.295","DOIUrl":"https://doi.org/10.1001/amajethics.2024.295","url":null,"abstract":"Drug importation raises several ethical and safety concerns relevant to prescribers and policy makers considering costs and benefits of international medicine importation. This article suggests key points to consider, especially from a policy perspective, when weighing imported medicines' perceived affordability and accessibility against additional resource expenditure needed to assure sufficient regulatory oversight and equitable distribution and to mitigate potential risks of harm to patients.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"259 1","pages":"E295-302"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140780544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.348
Mollie R. Gordon, Rebecca Chen, John Coverdale, Mike Schiller, Hanni Stoklosa, Phuong Nguyen
There has been little attention given to roles played by human trafficking in health care organizations' supply chains. Hand sanitizers and gloves, for example, might be produced by forced labor, which tends to increase in prevalence during pandemics, mass violence, migration, or other global crises. This article considers the nature and scope of health care organizations' corporate and social responsibilities to procure products and personnel justly, offers recommendations to minimize possibilities that supplies are produced by forced labor, and advocates for a public health approach to limiting human trafficking in organizations' supply chains.
{"title":"How Should Health Care Organizations Limit Roles of Human Trafficking in Their Labor and Supply Chains?","authors":"Mollie R. Gordon, Rebecca Chen, John Coverdale, Mike Schiller, Hanni Stoklosa, Phuong Nguyen","doi":"10.1001/amajethics.2024.348","DOIUrl":"https://doi.org/10.1001/amajethics.2024.348","url":null,"abstract":"There has been little attention given to roles played by human trafficking in health care organizations' supply chains. Hand sanitizers and gloves, for example, might be produced by forced labor, which tends to increase in prevalence during pandemics, mass violence, migration, or other global crises. This article considers the nature and scope of health care organizations' corporate and social responsibilities to procure products and personnel justly, offers recommendations to minimize possibilities that supplies are produced by forced labor, and advocates for a public health approach to limiting human trafficking in organizations' supply chains.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"100 ","pages":"E348-356"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140756953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.334
Erin R Fox, Matthew K. Wynia
When any drug is in short supply, it must be rationed. Recent increases in the frequency of shortages require more rationing by clinicians. Most health systems have policies on managing drug shortages, but transparency of criteria according to which specific scarce medications should be rationed-and by whom-are rare. The COVID-19 pandemic offered several examples of clinical and ethical need to develop and implement clear, fair strategies for distributing medications in short supply. Lessons from the pandemic should inform strategies for managing drug shortages now and in the future.
{"title":"How Should Critical Medications Be Rationed During Shortages?","authors":"Erin R Fox, Matthew K. Wynia","doi":"10.1001/amajethics.2024.334","DOIUrl":"https://doi.org/10.1001/amajethics.2024.334","url":null,"abstract":"When any drug is in short supply, it must be rationed. Recent increases in the frequency of shortages require more rationing by clinicians. Most health systems have policies on managing drug shortages, but transparency of criteria according to which specific scarce medications should be rationed-and by whom-are rare. The COVID-19 pandemic offered several examples of clinical and ethical need to develop and implement clear, fair strategies for distributing medications in short supply. Lessons from the pandemic should inform strategies for managing drug shortages now and in the future.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"41 9","pages":"E334-340"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140783586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.289
Kavitha Nallathambi, Amy B Cadwallader
This commentary responds to a case about diethylene glycol-contaminated glycerin in cough syrup. Glycerin is a commonly used excipient in medicines to improve texture and taste. Excipients are typically pharmacologically inactive ingredients contained in prescription and over-the-counter drugs that play a critical role in the delivery, effectiveness, and stability of active drug substances. The commentary first canvasses how contaminants enter the excipient supply chains. One way is by misleading labeling or intentional adulteration by manufacturers or suppliers. Another way is by human or systemic error. This commentary then discusses quality control testing and suggests the ethical and clinical importance of increased transparency in excipient supply chains.
{"title":"How Should Regulators and Manufacturers Prevent Avoidable Deaths of Children From Contaminated Cough Syrup?","authors":"Kavitha Nallathambi, Amy B Cadwallader","doi":"10.1001/amajethics.2024.289","DOIUrl":"https://doi.org/10.1001/amajethics.2024.289","url":null,"abstract":"This commentary responds to a case about diethylene glycol-contaminated glycerin in cough syrup. Glycerin is a commonly used excipient in medicines to improve texture and taste. Excipients are typically pharmacologically inactive ingredients contained in prescription and over-the-counter drugs that play a critical role in the delivery, effectiveness, and stability of active drug substances. The commentary first canvasses how contaminants enter the excipient supply chains. One way is by misleading labeling or intentional adulteration by manufacturers or suppliers. Another way is by human or systemic error. This commentary then discusses quality control testing and suggests the ethical and clinical importance of increased transparency in excipient supply chains.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"71 3","pages":"E289-294"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140792709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.282
Courtney Perlino, Hilary Daniel, Amy B Cadwallader
The World Health Organization (WHO) published its first Essential Medicines List (EML) in 1977, and it is updated biennially. One might reasonably think drugs on the EML are there because they are critical to effective, evidence-based patient care and intervention. One might not reasonably guess, however, that a particular drug's supply chain vulnerabilities that make it a shortage risk would contribute to a drug's listing on the EML. This commentary on a case first describes why the WHO makes the EML and suggests reasons why it might be important to consider a drug's shortage risk when revising and updating it. This commentary also suggests how distinguishing "essential" drugs from "vulnerable" drugs could bolster supply chain resiliency and mitigate drug shortages' disruptions to patient care.
{"title":"Which Drugs Should Be on the Essential Medicines List?","authors":"Courtney Perlino, Hilary Daniel, Amy B Cadwallader","doi":"10.1001/amajethics.2024.282","DOIUrl":"https://doi.org/10.1001/amajethics.2024.282","url":null,"abstract":"The World Health Organization (WHO) published its first Essential Medicines List (EML) in 1977, and it is updated biennially. One might reasonably think drugs on the EML are there because they are critical to effective, evidence-based patient care and intervention. One might not reasonably guess, however, that a particular drug's supply chain vulnerabilities that make it a shortage risk would contribute to a drug's listing on the EML. This commentary on a case first describes why the WHO makes the EML and suggests reasons why it might be important to consider a drug's shortage risk when revising and updating it. This commentary also suggests how distinguishing \"essential\" drugs from \"vulnerable\" drugs could bolster supply chain resiliency and mitigate drug shortages' disruptions to patient care.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"64 17","pages":"E282-288"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140791263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.341
C. Ching, Muhammad H. Zaman
Reliable, adequate supply of essential items, including quality-assured medicines, is hard to maintain in refugee camps in low- and middle-income countries. Disruption of medicine supply chains delays treatment for displaced persons and drives procurement of poor-quality products, often from unauthorized or unlicensed sellers. This article explains how current strategies and policies disrupt reliable flow of safe medicines to refugee camps and calls on stakeholders to rigorously map medicine supply chains to refugee camps, which would help identify strategies to improve displaced persons' access to quality-assured medicines.
{"title":"Mapping a Way to Displaced Persons' Access to Quality Medicines.","authors":"C. Ching, Muhammad H. Zaman","doi":"10.1001/amajethics.2024.341","DOIUrl":"https://doi.org/10.1001/amajethics.2024.341","url":null,"abstract":"Reliable, adequate supply of essential items, including quality-assured medicines, is hard to maintain in refugee camps in low- and middle-income countries. Disruption of medicine supply chains delays treatment for displaced persons and drives procurement of poor-quality products, often from unauthorized or unlicensed sellers. This article explains how current strategies and policies disrupt reliable flow of safe medicines to refugee camps and calls on stakeholders to rigorously map medicine supply chains to refugee camps, which would help identify strategies to improve displaced persons' access to quality-assured medicines.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"53 36","pages":"E341-347"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140796161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.306
Matt Christian, Wejdan Bagais
Drug shortages are a persistent and serious problem in the United States, affecting patient care and health care costs. This article canvasses factors that contribute to drug shortages, such as manufacturing complexity, price, and quality inspection records. This article further proposes an early warning system and payment, contracting, and pricing innovations to mitigate drug shortages and offers data-driven recommendations to stakeholders looking to protect the supply of quality medicines.
{"title":"Which Data Analytics Tool Should We Use to Evaluate Risk in Upstream Drug Supply Chains?","authors":"Matt Christian, Wejdan Bagais","doi":"10.1001/amajethics.2024.306","DOIUrl":"https://doi.org/10.1001/amajethics.2024.306","url":null,"abstract":"Drug shortages are a persistent and serious problem in the United States, affecting patient care and health care costs. This article canvasses factors that contribute to drug shortages, such as manufacturing complexity, price, and quality inspection records. This article further proposes an early warning system and payment, contracting, and pricing innovations to mitigate drug shortages and offers data-driven recommendations to stakeholders looking to protect the supply of quality medicines.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"119 ","pages":"E306-314"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140761957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.321
Mahshid Abir, Bradley Martin
The COVID-19 pandemic exposed vulnerabilities of the United States' routine and emergency supply chains of medicines and critical equipment. These vulnerabilities underscore an urgent need to prevent routine and emergency shortages by making drug manufacturing more transparent and by tracking how key supplies get to end users. Near real-time surveillance systems must be developed to monitor fluctuations in supplies of medicines and equipment. Implementation of such systems will require getting key stakeholders (clinicians, administrators, community members, manufacturers, and policy makers) to collaborate.
{"title":"Surveillance and Security in US Medicine and Equipment Supply Chains.","authors":"Mahshid Abir, Bradley Martin","doi":"10.1001/amajethics.2024.321","DOIUrl":"https://doi.org/10.1001/amajethics.2024.321","url":null,"abstract":"The COVID-19 pandemic exposed vulnerabilities of the United States' routine and emergency supply chains of medicines and critical equipment. These vulnerabilities underscore an urgent need to prevent routine and emergency shortages by making drug manufacturing more transparent and by tracking how key supplies get to end users. Near real-time surveillance systems must be developed to monitor fluctuations in supplies of medicines and equipment. Implementation of such systems will require getting key stakeholders (clinicians, administrators, community members, manufacturers, and policy makers) to collaborate.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"66 7","pages":"E321-326"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140769824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1001/amajethics.2024.315
Geoff Hollett, Jennie B Jarrett
The Strategic National Stockpile (SNS) is a national system maintained by the US federal government to deliver medical supplies during emergencies. In the past, the SNS has been used to mitigate public health consequences of tragedies, such as Hurricane Katrina and Ebola outbreaks. However, challenges in maintaining and utilizing the SNS for patient safety are prevalent. This article canvasses ways in which the SNS is accessed and suggests needed changes in the wake of the COVID-19 pandemic.
{"title":"How Should Resources From National Stockpiles Be Managed?","authors":"Geoff Hollett, Jennie B Jarrett","doi":"10.1001/amajethics.2024.315","DOIUrl":"https://doi.org/10.1001/amajethics.2024.315","url":null,"abstract":"The Strategic National Stockpile (SNS) is a national system maintained by the US federal government to deliver medical supplies during emergencies. In the past, the SNS has been used to mitigate public health consequences of tragedies, such as Hurricane Katrina and Ebola outbreaks. However, challenges in maintaining and utilizing the SNS for patient safety are prevalent. This article canvasses ways in which the SNS is accessed and suggests needed changes in the wake of the COVID-19 pandemic.","PeriodicalId":505099,"journal":{"name":"AMA Journal of Ethics","volume":"769 1","pages":"E315-320"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140775332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}