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Creating a Sustainable and Reliable Emergency Preparedness Program to Promote Appropriate Health Care Resources Use
Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.1 These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.4
Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.
Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.4
The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members.
2018 Alaska Earthquake
On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.
During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).5 Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.6 Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.7 However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.
As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.
Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.
During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.
Observations
A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.
Identified gaps
Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.8 EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.
Pharmacists play a vital role in managing chronic diseases.9 Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.9 Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).
Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.10
Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.6 Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.11 The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.12
Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.13 Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.14 However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.
Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.15 The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.18
Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.
Emergency Preparation Program
To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.
EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager.
Discussion
In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.19 This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.
Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training.
In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.
It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).
Conclusions
Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.
1. Ritchie H, Roser M. Natural disasters. Updated November 2019. Accessed March 12, 2021. https://ourworldindata.org/natural-disasters
2. Freedy JR, Simpson WM Jr. Disaster-related physical and mental health: a role for the family physician. Am Fam Physician. 2007;75(6):841-846.
3. Martin U. Health after disaster: a perspective of psychological/health reactions to disaster. Cogent Psychol. 2015;2(1):1053741. doi:10.1080/23311908.2015.1053741
4. Joy K. Ripple effect: how hurricanes and other disasters affect hospital care. Published September 11, 2017. Accessed March 12, 2021. https://labblog.uofmhealth.org/industry-dx/ripple-effect-how-hurricanes-and-other-disasters-affect-hospital-care
5. Krousel-Wood MA, Islam T, Muntner P, et al. Medication adherence in older clinic patients with hypertension after Hurricane Katrina: implications for clinical practice and disaster management. Am J Med Sci. 2008;336(2):99-104. doi:10.1097/MAJ.0b013e318180f14f
6. Cefalu WT, Smith SR, Blonde L, Fonseca V. The Hurricane Katrina aftermath and its impact on diabetes care: observations from “ground zero”: lessons in disaster preparedness of people with diabetes. Diabetes Care. 2006;29(1):158-160. doi:10.2337/diacare.29.1.158
7. Fonseca VA, Smith H, Kuhadiya N, et al. Impact of a natural disaster on diabetes: exacerbation of disparities and long-term consequences. Diabetes Care. 2009;32(9):1632-1638. doi:10.2337/dc09-0670
8. Suneja A, Chandler TE, Schlegelmilch J, May M, Redlener IE; Columbia University Earth Institute. Chronic disease after natural disasters: public health, policy, and provider perspectives. Published November 12, 2018. Accessed March 12, 2021. doi:10.7916/D8ZP5Q23
9. Kehrer JP, Eberhart G, Wing M, Horon K. Pharmacy’s role in a modern health continuum. Can Pharm J (Ott). 2013;146(6):321-324. doi:10.1177/1715163513506370
10. Shearer MP, Geleta A, Adalja A, Gronvall GK; Johns Hopkins Bloomberg School of Public Health Center for Health Security. Serving the greater good: public health & community pharmacy partnerships. Published October 2017. Accessed March 12, 2021. https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2017/public-health-and-community-pharmacy-partnerships-report.pdf
11. Flowers L, Wick J, Figg WD Sr, et al. U.S. Public Health Service Commissioned Corps pharmacists: making a difference in advancing the nation’s health. J Am Pharm Assoc (2003). 2009;49(3):446-452. doi:10.1331/JAPhA.2009.08036
12. American Society of Health-System Pharmacists. ASHP Statement on the Role of Health-System Pharmacists in Public Health. Am J Health Syst Pharm. 2008;65(5):462-467. doi:10.2146/ajhp070399
13. Deloitte. Data USA: pharmacists. Accessed June 2, 2020. https://datausa.io/profile/soc/pharmacists
14. Menighan TE. Pharmacists have major role in emergency response. Pharmacy Today. 2016;22(8):8. doi:10.1016/j.ptdy.2016.07.009
15. American Association of Colleges of Pharmacy. Academic pharmacy’s vital statistics. Updated July 2020. Accessed March 12, 2021. https://www.aacp.org/article/academic-pharmacys-vital-statistics
16. American Pharmacists Association. APhA-ASP Operation Heart. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-heart
17. World Health Organization. Noncommunicable diseases. Updated June 1, 2018. Accessed March 12, 2021. https://www.who.int/en/news-room/fact-sheets/detail/noncommunicable-diseases
18. American Pharmacists Association. APhA-ASP Operation Diabetes. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-diabetes
19. Reeve M, Wizemann T, Altevogt B. Enabling Rapid and Sustainable Public Health Research During Disasters: Summary of a Joint Workshop by the Institute of Medicine and the U.S. Department of Health and Human Services. National Academies Press; 2015.
Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.1 These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.4
Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.
Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.4
The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members.
2018 Alaska Earthquake
On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.
During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).5 Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.6 Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.7 However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.
As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.
Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.
During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.
Observations
A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.
Identified gaps
Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.8 EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.
Pharmacists play a vital role in managing chronic diseases.9 Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.9 Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).
Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.10
Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.6 Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.11 The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.12
Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.13 Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.14 However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.
Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.15 The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.18
Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.
Emergency Preparation Program
To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.
EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager.
Discussion
In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.19 This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.
Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training.
In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.
It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).
Conclusions
Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.
Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.1 These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.4
Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.
Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.4
The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members.
2018 Alaska Earthquake
On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.
During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).5 Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.6 Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.7 However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.
As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.
Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.
During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.
Observations
A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.
Identified gaps
Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.8 EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.
Pharmacists play a vital role in managing chronic diseases.9 Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.9 Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).
Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.10
Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.6 Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.11 The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.12
Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.13 Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.14 However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.
Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.15 The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.18
Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.
Emergency Preparation Program
To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.
EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager.
Discussion
In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.19 This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.
Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training.
In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.
It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).
Conclusions
Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.
1. Ritchie H, Roser M. Natural disasters. Updated November 2019. Accessed March 12, 2021. https://ourworldindata.org/natural-disasters
2. Freedy JR, Simpson WM Jr. Disaster-related physical and mental health: a role for the family physician. Am Fam Physician. 2007;75(6):841-846.
3. Martin U. Health after disaster: a perspective of psychological/health reactions to disaster. Cogent Psychol. 2015;2(1):1053741. doi:10.1080/23311908.2015.1053741
4. Joy K. Ripple effect: how hurricanes and other disasters affect hospital care. Published September 11, 2017. Accessed March 12, 2021. https://labblog.uofmhealth.org/industry-dx/ripple-effect-how-hurricanes-and-other-disasters-affect-hospital-care
5. Krousel-Wood MA, Islam T, Muntner P, et al. Medication adherence in older clinic patients with hypertension after Hurricane Katrina: implications for clinical practice and disaster management. Am J Med Sci. 2008;336(2):99-104. doi:10.1097/MAJ.0b013e318180f14f
6. Cefalu WT, Smith SR, Blonde L, Fonseca V. The Hurricane Katrina aftermath and its impact on diabetes care: observations from “ground zero”: lessons in disaster preparedness of people with diabetes. Diabetes Care. 2006;29(1):158-160. doi:10.2337/diacare.29.1.158
7. Fonseca VA, Smith H, Kuhadiya N, et al. Impact of a natural disaster on diabetes: exacerbation of disparities and long-term consequences. Diabetes Care. 2009;32(9):1632-1638. doi:10.2337/dc09-0670
8. Suneja A, Chandler TE, Schlegelmilch J, May M, Redlener IE; Columbia University Earth Institute. Chronic disease after natural disasters: public health, policy, and provider perspectives. Published November 12, 2018. Accessed March 12, 2021. doi:10.7916/D8ZP5Q23
9. Kehrer JP, Eberhart G, Wing M, Horon K. Pharmacy’s role in a modern health continuum. Can Pharm J (Ott). 2013;146(6):321-324. doi:10.1177/1715163513506370
10. Shearer MP, Geleta A, Adalja A, Gronvall GK; Johns Hopkins Bloomberg School of Public Health Center for Health Security. Serving the greater good: public health & community pharmacy partnerships. Published October 2017. Accessed March 12, 2021. https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2017/public-health-and-community-pharmacy-partnerships-report.pdf
11. Flowers L, Wick J, Figg WD Sr, et al. U.S. Public Health Service Commissioned Corps pharmacists: making a difference in advancing the nation’s health. J Am Pharm Assoc (2003). 2009;49(3):446-452. doi:10.1331/JAPhA.2009.08036
12. American Society of Health-System Pharmacists. ASHP Statement on the Role of Health-System Pharmacists in Public Health. Am J Health Syst Pharm. 2008;65(5):462-467. doi:10.2146/ajhp070399
13. Deloitte. Data USA: pharmacists. Accessed June 2, 2020. https://datausa.io/profile/soc/pharmacists
14. Menighan TE. Pharmacists have major role in emergency response. Pharmacy Today. 2016;22(8):8. doi:10.1016/j.ptdy.2016.07.009
15. American Association of Colleges of Pharmacy. Academic pharmacy’s vital statistics. Updated July 2020. Accessed March 12, 2021. https://www.aacp.org/article/academic-pharmacys-vital-statistics
16. American Pharmacists Association. APhA-ASP Operation Heart. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-heart
17. World Health Organization. Noncommunicable diseases. Updated June 1, 2018. Accessed March 12, 2021. https://www.who.int/en/news-room/fact-sheets/detail/noncommunicable-diseases
18. American Pharmacists Association. APhA-ASP Operation Diabetes. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-diabetes
19. Reeve M, Wizemann T, Altevogt B. Enabling Rapid and Sustainable Public Health Research During Disasters: Summary of a Joint Workshop by the Institute of Medicine and the U.S. Department of Health and Human Services. National Academies Press; 2015.
1. Ritchie H, Roser M. Natural disasters. Updated November 2019. Accessed March 12, 2021. https://ourworldindata.org/natural-disasters
2. Freedy JR, Simpson WM Jr. Disaster-related physical and mental health: a role for the family physician. Am Fam Physician. 2007;75(6):841-846.
3. Martin U. Health after disaster: a perspective of psychological/health reactions to disaster. Cogent Psychol. 2015;2(1):1053741. doi:10.1080/23311908.2015.1053741
4. Joy K. Ripple effect: how hurricanes and other disasters affect hospital care. Published September 11, 2017. Accessed March 12, 2021. https://labblog.uofmhealth.org/industry-dx/ripple-effect-how-hurricanes-and-other-disasters-affect-hospital-care
5. Krousel-Wood MA, Islam T, Muntner P, et al. Medication adherence in older clinic patients with hypertension after Hurricane Katrina: implications for clinical practice and disaster management. Am J Med Sci. 2008;336(2):99-104. doi:10.1097/MAJ.0b013e318180f14f
6. Cefalu WT, Smith SR, Blonde L, Fonseca V. The Hurricane Katrina aftermath and its impact on diabetes care: observations from “ground zero”: lessons in disaster preparedness of people with diabetes. Diabetes Care. 2006;29(1):158-160. doi:10.2337/diacare.29.1.158
7. Fonseca VA, Smith H, Kuhadiya N, et al. Impact of a natural disaster on diabetes: exacerbation of disparities and long-term consequences. Diabetes Care. 2009;32(9):1632-1638. doi:10.2337/dc09-0670
8. Suneja A, Chandler TE, Schlegelmilch J, May M, Redlener IE; Columbia University Earth Institute. Chronic disease after natural disasters: public health, policy, and provider perspectives. Published November 12, 2018. Accessed March 12, 2021. doi:10.7916/D8ZP5Q23
9. Kehrer JP, Eberhart G, Wing M, Horon K. Pharmacy’s role in a modern health continuum. Can Pharm J (Ott). 2013;146(6):321-324. doi:10.1177/1715163513506370
10. Shearer MP, Geleta A, Adalja A, Gronvall GK; Johns Hopkins Bloomberg School of Public Health Center for Health Security. Serving the greater good: public health & community pharmacy partnerships. Published October 2017. Accessed March 12, 2021. https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2017/public-health-and-community-pharmacy-partnerships-report.pdf
11. Flowers L, Wick J, Figg WD Sr, et al. U.S. Public Health Service Commissioned Corps pharmacists: making a difference in advancing the nation’s health. J Am Pharm Assoc (2003). 2009;49(3):446-452. doi:10.1331/JAPhA.2009.08036
12. American Society of Health-System Pharmacists. ASHP Statement on the Role of Health-System Pharmacists in Public Health. Am J Health Syst Pharm. 2008;65(5):462-467. doi:10.2146/ajhp070399
13. Deloitte. Data USA: pharmacists. Accessed June 2, 2020. https://datausa.io/profile/soc/pharmacists
14. Menighan TE. Pharmacists have major role in emergency response. Pharmacy Today. 2016;22(8):8. doi:10.1016/j.ptdy.2016.07.009
15. American Association of Colleges of Pharmacy. Academic pharmacy’s vital statistics. Updated July 2020. Accessed March 12, 2021. https://www.aacp.org/article/academic-pharmacys-vital-statistics
16. American Pharmacists Association. APhA-ASP Operation Heart. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-heart
17. World Health Organization. Noncommunicable diseases. Updated June 1, 2018. Accessed March 12, 2021. https://www.who.int/en/news-room/fact-sheets/detail/noncommunicable-diseases
18. American Pharmacists Association. APhA-ASP Operation Diabetes. Accessed March 12, 2021. https://www.pharmacist.com/apha-asp-operation-diabetes
19. Reeve M, Wizemann T, Altevogt B. Enabling Rapid and Sustainable Public Health Research During Disasters: Summary of a Joint Workshop by the Institute of Medicine and the U.S. Department of Health and Human Services. National Academies Press; 2015.
Cancer screening stopped by pandemic: Repercussions to come?
Last year, cancer screening programs around the world ground to a halt as SARS-CoV-2 infection rates surged globally. The effect of this slowdown is now becoming clear.
Thousands of cancer diagnoses are “missing,” and oncologists worry that this will lead to more advanced cancers and higher mortality for years to come.
“I feel like this is an earthquake that’s rocked our health care system. My guess is that you’ll probably still see repercussions of this over the next couple of years at least,” said Sharon Chang, MD, an attending surgical oncologist in the Permanente Medical Group, Fremont, Calif.
She was senior author of a study that analyzed the effects of the slowdown in mammography screening as a result of California’s “shelter-in-place” order on March 17, 2020. In the 2 months that followed, there were 64% fewer breast cancer diagnoses at 21 Kaiser Permanente medical centers, compared with the same period in 2019 (250 vs. 703).
In effect, approximately 450 breast cancer patients had “disappeared,” said coauthor Annie Tang, MD, a research fellow at the University of California, San Francisco, East Bay surgery program.
“What surprised me most from our data was the sheer number of breast cancer patients that were missing,” Dr. Tang said in an interview.
A similar picture has emerged elsewhere.
In Boston, an estimated 1,438 cancerous and precancerous lesions “went missing” during the first 3 months of pandemic shutdown, according to a study from the Massachusetts General Brigham health care system.
In this study, the investigators assessed screening rates for five cancers – breast cancer (mammography), prostate cancer (prostate-specific antigen testing), colorectal cancer (colonoscopy), cervical cancer (Papanicolaou tests), and lung cancer (low-dose CT).
Screening rates during the first peak of the pandemic (March 2 to June 2, 2020) were compared with those during the preceding and following 3 months and during the same 3 months in 2019.
The results showed a pronounced drop in screening rates during the peak pandemic period, compared with the three control periods. Decreases occurred for all screening tests and ranged from –60% to –82%.
There were also significant decreases in cancer diagnoses resulting from the decreases in screening tests, ranging from –19% to –78%.
“Quantifying the actual problem made us realize how much work needs to be done to get us back to prepandemic numbers,” said senior author Quoc-Dien Trinh, MD, FACS, codirector of the Dana Farber/Brigham and Women’s prostate cancer program.
In the Canadian province of Alberta, a similar decrease in cancer diagnoses occurred during the early days of the pandemic.
By the end of 2020, Alberta was “missing” approximately 2,000 cases of invasive cancers and 1,000 cases of noninvasive cancers, Doug Stewart, MD, senior medical director at the Cancer Strategic Clinical Network (SCN) of Alberta Health Services, told this news organization.
Dr. Stewart is able to track cancer diagnoses in Alberta almost in real time through a mandatory cancer registry. Within a month of shutdown, there was a 30% decrease in diagnoses of invasive cancers and a 50% decrease “in the kind of preinvasive cancers that, for the most part, are picked up by screening programs,” said Dr. Stewart.
After the health care system opened up again in the summer, Stewart said, noninvasive cancer diagnoses continued to be 20% lower than expected. There was a 10% shortfall in invasive cancer diagnoses.
The number of diagnoses had returned to normal by December 2020. However, Dr. Stewart is worried that this fact conceals a terrible truth.
The worry is over the backlog. Although the number of diagnoses is now similar to what it was before the pandemic, “people are presenting later, and maybe the cancer is more advanced,” he speculated.
His team at Alberta Health Services is assessing whether the cancers that are being diagnosed now are more advanced. Initial results are anticipated by late April 2021.
In the United Kingdom, there was a similar halt in cancer screening as a result of the country’s lockdown. Researchers now predict an uptick in cancer diagnoses.
Ajay Aggarwal, MD, PhD, consultant clinical oncologist and associate professor at the London School of Hygiene and Tropical Medicine, and colleagues have estimated that at least 3,500 deaths from breast, colorectal, esophageal, and lung cancer will occur during the next 5 years in England that could have been avoided had it not been for the lockdown measures necessitated by the pandemic.
Speaking to this news organization, Dr. Aggarwal warned that these numbers, which are from a modeling study published in August 2020, are “extremely conservative,” because the investigators considered diagnostic delays over only a 3-month period, the analysis involved only four cancers, and it did not reflect deferral of cancer treatment.
“It felt like it was the tip of the iceberg,” Dr. Aggarwal said. He warns that more recent data suggest that “diagnostic delays are probably worse than we predicted.”
He suspects that there is more at play than screening cancellations.
In another study conducted in the United Kingdom, data show “a falling edge of referrals” from primary care to cancer centers early in the pandemic. In that study, investigators analyzed real-time weekly hospital data from eight large British hospitals and found that urgent cancer referrals fell 70% at their lowest point.
“It really surprised me that the urgent referrals dropped so drastically,” said lead author Alvina Lai, PhD, a lecturer in health data analytics at University College London.
She attributed this in part to patients’ adherence to lockdown rules. “Patients are trying to follow government guidelines to stay home and not go to [general practitioners] unless necessary,” Dr. Lai explained in an interview.
Canada, like the United Kingdom, has a publicly funded health care system. Dr. Stewart came to a similar conclusion. “Some patients who have been diagnosed with cancer ... have told me it took them an extra couple of months to even contact the family doc, because they ... didn’t want to bother the family doctor with something that wasn’t COVID, this kind of guilt. They want to do something good for society. You know, most people are just really nice people, and they don’t want to bother the health care system if they don’t have COVID,” Dr. Stewart said.
Shelley Fuld Nasso, CEO of the National Coalition for Cancer Survivorship, a nonprofit organization based in Silver Spring, Md., agreed that screening shutdowns are not the only danger. “While we agree that screening is really important, we also want to make sure patients are following up with their physicians about symptoms that they have,” she said.
“Some of the speculation or concern about increased mortality for cancer is related to screening, but some of it is related to delayed diagnosis because of not following up on symptoms. ... What concerns me is not everyone has that ability or willingness to advocate for themselves,” she said.
Speaking at a press briefing held by the American Society for Radiation Oncology on March 30, Dr. Nasso related a case involving a patient who experienced severe arm pain. In a teleconsultation with her primary care physician, her condition was diagnosed as arthritis. She was subsequently diagnosed in the ED as having multiple myeloma.
Patients who “feel fine” may postpone their checkups to avoid going to the hospital and risking exposure to COVID-19.
“Some patients are still hesitant about returning for their mammograms or coming in if they feel a breast lump,” Dr. Tang said. “That fear of COVID-19 is still out there, and we don’t know how long patients are going to delay.”
In London, Dr. Aggarwal saw a similar response to the pandemic. “People were overestimating quite significantly what their risk of death was from acquiring COVID-19, and I think that balance was never [redressed] explicitly,” he said.
Public health initiatives to rebalance the messaging are now underway.
Public Health England and National Health Service England launched their Help Us Help You campaign in October 2020. The public information campaign urges people to speak to their doctors if they were “worried about a symptom that could be cancer.”
In Canada, the provincial government in Alberta has launched a public awareness campaign that conveys the message, “cancer has not gone away.”
“Cancer is still the No. 1 cause of potential life-years lost, despite COVID,” Dr. Stewart said. “We need to do what we can to make sure there’s no slippage in survival rates.”
Dr. Tang, Dr. Chang, Dr. Lai, Dr. Stewart, and Dr. Aggarwal have disclosed no relevant financial relationship. Dr. Trinh has received personal fees from Astellas, Bayer, and Janssen and grants from Intuitive Surgical.
A version of this article first appeared on Medscape.com.
Last year, cancer screening programs around the world ground to a halt as SARS-CoV-2 infection rates surged globally. The effect of this slowdown is now becoming clear.
Thousands of cancer diagnoses are “missing,” and oncologists worry that this will lead to more advanced cancers and higher mortality for years to come.
“I feel like this is an earthquake that’s rocked our health care system. My guess is that you’ll probably still see repercussions of this over the next couple of years at least,” said Sharon Chang, MD, an attending surgical oncologist in the Permanente Medical Group, Fremont, Calif.
She was senior author of a study that analyzed the effects of the slowdown in mammography screening as a result of California’s “shelter-in-place” order on March 17, 2020. In the 2 months that followed, there were 64% fewer breast cancer diagnoses at 21 Kaiser Permanente medical centers, compared with the same period in 2019 (250 vs. 703).
In effect, approximately 450 breast cancer patients had “disappeared,” said coauthor Annie Tang, MD, a research fellow at the University of California, San Francisco, East Bay surgery program.
“What surprised me most from our data was the sheer number of breast cancer patients that were missing,” Dr. Tang said in an interview.
A similar picture has emerged elsewhere.
In Boston, an estimated 1,438 cancerous and precancerous lesions “went missing” during the first 3 months of pandemic shutdown, according to a study from the Massachusetts General Brigham health care system.
In this study, the investigators assessed screening rates for five cancers – breast cancer (mammography), prostate cancer (prostate-specific antigen testing), colorectal cancer (colonoscopy), cervical cancer (Papanicolaou tests), and lung cancer (low-dose CT).
Screening rates during the first peak of the pandemic (March 2 to June 2, 2020) were compared with those during the preceding and following 3 months and during the same 3 months in 2019.
The results showed a pronounced drop in screening rates during the peak pandemic period, compared with the three control periods. Decreases occurred for all screening tests and ranged from –60% to –82%.
There were also significant decreases in cancer diagnoses resulting from the decreases in screening tests, ranging from –19% to –78%.
“Quantifying the actual problem made us realize how much work needs to be done to get us back to prepandemic numbers,” said senior author Quoc-Dien Trinh, MD, FACS, codirector of the Dana Farber/Brigham and Women’s prostate cancer program.
In the Canadian province of Alberta, a similar decrease in cancer diagnoses occurred during the early days of the pandemic.
By the end of 2020, Alberta was “missing” approximately 2,000 cases of invasive cancers and 1,000 cases of noninvasive cancers, Doug Stewart, MD, senior medical director at the Cancer Strategic Clinical Network (SCN) of Alberta Health Services, told this news organization.
Dr. Stewart is able to track cancer diagnoses in Alberta almost in real time through a mandatory cancer registry. Within a month of shutdown, there was a 30% decrease in diagnoses of invasive cancers and a 50% decrease “in the kind of preinvasive cancers that, for the most part, are picked up by screening programs,” said Dr. Stewart.
After the health care system opened up again in the summer, Stewart said, noninvasive cancer diagnoses continued to be 20% lower than expected. There was a 10% shortfall in invasive cancer diagnoses.
The number of diagnoses had returned to normal by December 2020. However, Dr. Stewart is worried that this fact conceals a terrible truth.
The worry is over the backlog. Although the number of diagnoses is now similar to what it was before the pandemic, “people are presenting later, and maybe the cancer is more advanced,” he speculated.
His team at Alberta Health Services is assessing whether the cancers that are being diagnosed now are more advanced. Initial results are anticipated by late April 2021.
In the United Kingdom, there was a similar halt in cancer screening as a result of the country’s lockdown. Researchers now predict an uptick in cancer diagnoses.
Ajay Aggarwal, MD, PhD, consultant clinical oncologist and associate professor at the London School of Hygiene and Tropical Medicine, and colleagues have estimated that at least 3,500 deaths from breast, colorectal, esophageal, and lung cancer will occur during the next 5 years in England that could have been avoided had it not been for the lockdown measures necessitated by the pandemic.
Speaking to this news organization, Dr. Aggarwal warned that these numbers, which are from a modeling study published in August 2020, are “extremely conservative,” because the investigators considered diagnostic delays over only a 3-month period, the analysis involved only four cancers, and it did not reflect deferral of cancer treatment.
“It felt like it was the tip of the iceberg,” Dr. Aggarwal said. He warns that more recent data suggest that “diagnostic delays are probably worse than we predicted.”
He suspects that there is more at play than screening cancellations.
In another study conducted in the United Kingdom, data show “a falling edge of referrals” from primary care to cancer centers early in the pandemic. In that study, investigators analyzed real-time weekly hospital data from eight large British hospitals and found that urgent cancer referrals fell 70% at their lowest point.
“It really surprised me that the urgent referrals dropped so drastically,” said lead author Alvina Lai, PhD, a lecturer in health data analytics at University College London.
She attributed this in part to patients’ adherence to lockdown rules. “Patients are trying to follow government guidelines to stay home and not go to [general practitioners] unless necessary,” Dr. Lai explained in an interview.
Canada, like the United Kingdom, has a publicly funded health care system. Dr. Stewart came to a similar conclusion. “Some patients who have been diagnosed with cancer ... have told me it took them an extra couple of months to even contact the family doc, because they ... didn’t want to bother the family doctor with something that wasn’t COVID, this kind of guilt. They want to do something good for society. You know, most people are just really nice people, and they don’t want to bother the health care system if they don’t have COVID,” Dr. Stewart said.
Shelley Fuld Nasso, CEO of the National Coalition for Cancer Survivorship, a nonprofit organization based in Silver Spring, Md., agreed that screening shutdowns are not the only danger. “While we agree that screening is really important, we also want to make sure patients are following up with their physicians about symptoms that they have,” she said.
“Some of the speculation or concern about increased mortality for cancer is related to screening, but some of it is related to delayed diagnosis because of not following up on symptoms. ... What concerns me is not everyone has that ability or willingness to advocate for themselves,” she said.
Speaking at a press briefing held by the American Society for Radiation Oncology on March 30, Dr. Nasso related a case involving a patient who experienced severe arm pain. In a teleconsultation with her primary care physician, her condition was diagnosed as arthritis. She was subsequently diagnosed in the ED as having multiple myeloma.
Patients who “feel fine” may postpone their checkups to avoid going to the hospital and risking exposure to COVID-19.
“Some patients are still hesitant about returning for their mammograms or coming in if they feel a breast lump,” Dr. Tang said. “That fear of COVID-19 is still out there, and we don’t know how long patients are going to delay.”
In London, Dr. Aggarwal saw a similar response to the pandemic. “People were overestimating quite significantly what their risk of death was from acquiring COVID-19, and I think that balance was never [redressed] explicitly,” he said.
Public health initiatives to rebalance the messaging are now underway.
Public Health England and National Health Service England launched their Help Us Help You campaign in October 2020. The public information campaign urges people to speak to their doctors if they were “worried about a symptom that could be cancer.”
In Canada, the provincial government in Alberta has launched a public awareness campaign that conveys the message, “cancer has not gone away.”
“Cancer is still the No. 1 cause of potential life-years lost, despite COVID,” Dr. Stewart said. “We need to do what we can to make sure there’s no slippage in survival rates.”
Dr. Tang, Dr. Chang, Dr. Lai, Dr. Stewart, and Dr. Aggarwal have disclosed no relevant financial relationship. Dr. Trinh has received personal fees from Astellas, Bayer, and Janssen and grants from Intuitive Surgical.
A version of this article first appeared on Medscape.com.
Last year, cancer screening programs around the world ground to a halt as SARS-CoV-2 infection rates surged globally. The effect of this slowdown is now becoming clear.
Thousands of cancer diagnoses are “missing,” and oncologists worry that this will lead to more advanced cancers and higher mortality for years to come.
“I feel like this is an earthquake that’s rocked our health care system. My guess is that you’ll probably still see repercussions of this over the next couple of years at least,” said Sharon Chang, MD, an attending surgical oncologist in the Permanente Medical Group, Fremont, Calif.
She was senior author of a study that analyzed the effects of the slowdown in mammography screening as a result of California’s “shelter-in-place” order on March 17, 2020. In the 2 months that followed, there were 64% fewer breast cancer diagnoses at 21 Kaiser Permanente medical centers, compared with the same period in 2019 (250 vs. 703).
In effect, approximately 450 breast cancer patients had “disappeared,” said coauthor Annie Tang, MD, a research fellow at the University of California, San Francisco, East Bay surgery program.
“What surprised me most from our data was the sheer number of breast cancer patients that were missing,” Dr. Tang said in an interview.
A similar picture has emerged elsewhere.
In Boston, an estimated 1,438 cancerous and precancerous lesions “went missing” during the first 3 months of pandemic shutdown, according to a study from the Massachusetts General Brigham health care system.
In this study, the investigators assessed screening rates for five cancers – breast cancer (mammography), prostate cancer (prostate-specific antigen testing), colorectal cancer (colonoscopy), cervical cancer (Papanicolaou tests), and lung cancer (low-dose CT).
Screening rates during the first peak of the pandemic (March 2 to June 2, 2020) were compared with those during the preceding and following 3 months and during the same 3 months in 2019.
The results showed a pronounced drop in screening rates during the peak pandemic period, compared with the three control periods. Decreases occurred for all screening tests and ranged from –60% to –82%.
There were also significant decreases in cancer diagnoses resulting from the decreases in screening tests, ranging from –19% to –78%.
“Quantifying the actual problem made us realize how much work needs to be done to get us back to prepandemic numbers,” said senior author Quoc-Dien Trinh, MD, FACS, codirector of the Dana Farber/Brigham and Women’s prostate cancer program.
In the Canadian province of Alberta, a similar decrease in cancer diagnoses occurred during the early days of the pandemic.
By the end of 2020, Alberta was “missing” approximately 2,000 cases of invasive cancers and 1,000 cases of noninvasive cancers, Doug Stewart, MD, senior medical director at the Cancer Strategic Clinical Network (SCN) of Alberta Health Services, told this news organization.
Dr. Stewart is able to track cancer diagnoses in Alberta almost in real time through a mandatory cancer registry. Within a month of shutdown, there was a 30% decrease in diagnoses of invasive cancers and a 50% decrease “in the kind of preinvasive cancers that, for the most part, are picked up by screening programs,” said Dr. Stewart.
After the health care system opened up again in the summer, Stewart said, noninvasive cancer diagnoses continued to be 20% lower than expected. There was a 10% shortfall in invasive cancer diagnoses.
The number of diagnoses had returned to normal by December 2020. However, Dr. Stewart is worried that this fact conceals a terrible truth.
The worry is over the backlog. Although the number of diagnoses is now similar to what it was before the pandemic, “people are presenting later, and maybe the cancer is more advanced,” he speculated.
His team at Alberta Health Services is assessing whether the cancers that are being diagnosed now are more advanced. Initial results are anticipated by late April 2021.
In the United Kingdom, there was a similar halt in cancer screening as a result of the country’s lockdown. Researchers now predict an uptick in cancer diagnoses.
Ajay Aggarwal, MD, PhD, consultant clinical oncologist and associate professor at the London School of Hygiene and Tropical Medicine, and colleagues have estimated that at least 3,500 deaths from breast, colorectal, esophageal, and lung cancer will occur during the next 5 years in England that could have been avoided had it not been for the lockdown measures necessitated by the pandemic.
Speaking to this news organization, Dr. Aggarwal warned that these numbers, which are from a modeling study published in August 2020, are “extremely conservative,” because the investigators considered diagnostic delays over only a 3-month period, the analysis involved only four cancers, and it did not reflect deferral of cancer treatment.
“It felt like it was the tip of the iceberg,” Dr. Aggarwal said. He warns that more recent data suggest that “diagnostic delays are probably worse than we predicted.”
He suspects that there is more at play than screening cancellations.
In another study conducted in the United Kingdom, data show “a falling edge of referrals” from primary care to cancer centers early in the pandemic. In that study, investigators analyzed real-time weekly hospital data from eight large British hospitals and found that urgent cancer referrals fell 70% at their lowest point.
“It really surprised me that the urgent referrals dropped so drastically,” said lead author Alvina Lai, PhD, a lecturer in health data analytics at University College London.
She attributed this in part to patients’ adherence to lockdown rules. “Patients are trying to follow government guidelines to stay home and not go to [general practitioners] unless necessary,” Dr. Lai explained in an interview.
Canada, like the United Kingdom, has a publicly funded health care system. Dr. Stewart came to a similar conclusion. “Some patients who have been diagnosed with cancer ... have told me it took them an extra couple of months to even contact the family doc, because they ... didn’t want to bother the family doctor with something that wasn’t COVID, this kind of guilt. They want to do something good for society. You know, most people are just really nice people, and they don’t want to bother the health care system if they don’t have COVID,” Dr. Stewart said.
Shelley Fuld Nasso, CEO of the National Coalition for Cancer Survivorship, a nonprofit organization based in Silver Spring, Md., agreed that screening shutdowns are not the only danger. “While we agree that screening is really important, we also want to make sure patients are following up with their physicians about symptoms that they have,” she said.
“Some of the speculation or concern about increased mortality for cancer is related to screening, but some of it is related to delayed diagnosis because of not following up on symptoms. ... What concerns me is not everyone has that ability or willingness to advocate for themselves,” she said.
Speaking at a press briefing held by the American Society for Radiation Oncology on March 30, Dr. Nasso related a case involving a patient who experienced severe arm pain. In a teleconsultation with her primary care physician, her condition was diagnosed as arthritis. She was subsequently diagnosed in the ED as having multiple myeloma.
Patients who “feel fine” may postpone their checkups to avoid going to the hospital and risking exposure to COVID-19.
“Some patients are still hesitant about returning for their mammograms or coming in if they feel a breast lump,” Dr. Tang said. “That fear of COVID-19 is still out there, and we don’t know how long patients are going to delay.”
In London, Dr. Aggarwal saw a similar response to the pandemic. “People were overestimating quite significantly what their risk of death was from acquiring COVID-19, and I think that balance was never [redressed] explicitly,” he said.
Public health initiatives to rebalance the messaging are now underway.
Public Health England and National Health Service England launched their Help Us Help You campaign in October 2020. The public information campaign urges people to speak to their doctors if they were “worried about a symptom that could be cancer.”
In Canada, the provincial government in Alberta has launched a public awareness campaign that conveys the message, “cancer has not gone away.”
“Cancer is still the No. 1 cause of potential life-years lost, despite COVID,” Dr. Stewart said. “We need to do what we can to make sure there’s no slippage in survival rates.”
Dr. Tang, Dr. Chang, Dr. Lai, Dr. Stewart, and Dr. Aggarwal have disclosed no relevant financial relationship. Dr. Trinh has received personal fees from Astellas, Bayer, and Janssen and grants from Intuitive Surgical.
A version of this article first appeared on Medscape.com.
TAVR feasible, comparable with surgery in rheumatic heart disease
Patients with rheumatic heart disease (RHD) appear to have comparable outcomes, whether undergoing transcatheter or surgical aortic valve replacement (TAVR/SAVR), and when compared with TAVR in patients with nonrheumatic aortic stenosis, a new Medicare study finds.
An analysis of data from 1,159 Medicare beneficiaries with rheumatic aortic stenosis revealed that, over a median follow-up of 19 months, there was no difference in all-cause mortality with TAVR vs. SAVR (11.2 vs. 7.0 per 100 person-years; adjusted hazard ratio, 1.53; P = .2).
Mortality was also similar after a median follow-up of 17 months between TAVR in patients with rheumatic aortic stenosis and 88,554 additional beneficiaries with nonrheumatic aortic stenosis (15.2 vs. 17.7 deaths per 100 person-years; aHR, 0.87; P = .2).
“We need collaboration between industry and society leaders in developed countries to initiate a randomized, controlled trial to address the feasibility of TAVR in rheumatic heart disease in younger populations who aren’t surgical candidates or if there’s a lack of surgical capabilities in countries, but this is an encouraging first sign,” lead author Amgad Mentias, MD, MSc, Cleveland Clinic Foundation, said in an interview.
Although the prevalence of rheumatic heart disease (RHD) has fallen to less than 5% or so in the United States and Europe, it remains a significant problem in developing and low-income countries, with more than 1 million deaths per year, he noted. RHD patients typically present at younger ages, often with concomitant aortic regurgitation and mitral valve disease, but have less calcification than degenerative calcific aortic stenosis.
Commenting on the results, published in the Journal of the American College of Cardiology, David F. Williams, PhD, said in an interview that “it is only now becoming possible to entertain the use of TAVR in such patients, and this paper demonstrates the feasibility of doing so.
“Although the study is based on geriatric patients of an industrialized country, it opens the door to the massive unmet clinical needs in poorer regions as well as emerging economies,” said Dr. Williams, a professor at the Wake Forest Institute for Regenerative Medicine, Winston-Salem, N.C., and coauthor of an accompanying editorial.
The study included Medicare beneficiaries treated from October 2015 to December 2017 for rheumatic aortic stenosis (TAVR, n = 605; SAVR, n = 55) or nonrheumatic aortic stenosis (n = 88,554).
Among those with rheumatic disease, SAVR patients were younger than TAVR patients (73.4 vs. 79.4 years), had a lower prevalence of most comorbidities, and were less frail (median frailty score, 5.3 vs. 11.3).
SAVR was associated with significantly higher weighted risk for in-hospital acute kidney injury (22.3% vs. 11.9%), blood transfusion (19.8% vs. 7.6%), cardiogenic shock (5.7% vs. 1.5%), new-onset atrial fibrillation (21.1% vs. 2.2%), and had longer hospital stays (median, 8 vs. 3 days), whereas new permanent pacemaker implantations trended higher with TAVR (12.5% vs 7.2%).
The TAVR and SAVR groups had comparable rates of adjusted in-hospital mortality (2.4% vs. 3.5%), 30-day mortality (3.6% vs. 3.2%), 30-day stroke (2.4% vs. 2.8%), and 1-year mortality (13.1% vs. 8.9%).
Among the two TAVR cohorts, patients with rheumatic disease were younger than those with nonrheumatic aortic stenosis (79.4 vs. 81.2 years); had a higher prevalence of heart failure, ischemic stroke, atrial fibrillation, and lung disease; and were more frail (median score, 11.3 vs. 6.9).
Still, there was no difference in weighted risk of in-hospital mortality (2.2% vs. 2.6%), 30-day mortality (3.6% vs. 3.7%), 30-day stroke (2.0% vs. 3.3%), or 1-year mortality (16.0% vs. 17.1%) between TAVR patients with and without rheumatic stenosis.
“We didn’t have specific information on echo[cardiography], so we don’t know how that affected our results, but one of the encouraging points is that after a median follow-up of almost 2 years, none of the patients who had TAVR in the rheumatic valve and who survived required redo aortic valve replacement,” Dr. Mentias said. “It’s still short term but it shows that for the short to mid term, the valve is durable.”
Data were not available on paravalvular regurgitation, an Achilles heel for TAVR, but Dr. Mentias said rates of this complication have come down significantly in the past 2 years with modifications to newer-generation TAVR valves.
Dr. Williams and colleagues say one main limitation of the study also highlights the major shortcoming of contemporary TAVRs when treating patients with RHD: “namely, their inadequate suitability for AR [aortic regurgitation], the predominant rheumatic lesion of the aortic valve” in low- to middle-income countries.
They pointed out that patients needing an aortic valve where RHD is rampant are at least 30 years younger than the 79-year-old TAVR recipients in the study.
In a comment, Dr. Williams said there are several unanswered questions about the full impact TAVR could have in the treatment of young RHD patients in underprivileged regions. “These mainly concern the durability of the valves in individuals who could expect greater longevity than the typical heart valve patient in the USA, and the adaptation of transcatheter techniques to provide cost-effective treatment in regions that lack the usual sophisticated clinical infrastructure.”
Dr. Mentias received support from a National Research Service Award institutional grant to the Abboud Cardiovascular Research Center. Dr. Williams and coauthors are directors of Strait Access Technologies.
A version of this article first appeared on Medscape.com.
Patients with rheumatic heart disease (RHD) appear to have comparable outcomes, whether undergoing transcatheter or surgical aortic valve replacement (TAVR/SAVR), and when compared with TAVR in patients with nonrheumatic aortic stenosis, a new Medicare study finds.
An analysis of data from 1,159 Medicare beneficiaries with rheumatic aortic stenosis revealed that, over a median follow-up of 19 months, there was no difference in all-cause mortality with TAVR vs. SAVR (11.2 vs. 7.0 per 100 person-years; adjusted hazard ratio, 1.53; P = .2).
Mortality was also similar after a median follow-up of 17 months between TAVR in patients with rheumatic aortic stenosis and 88,554 additional beneficiaries with nonrheumatic aortic stenosis (15.2 vs. 17.7 deaths per 100 person-years; aHR, 0.87; P = .2).
“We need collaboration between industry and society leaders in developed countries to initiate a randomized, controlled trial to address the feasibility of TAVR in rheumatic heart disease in younger populations who aren’t surgical candidates or if there’s a lack of surgical capabilities in countries, but this is an encouraging first sign,” lead author Amgad Mentias, MD, MSc, Cleveland Clinic Foundation, said in an interview.
Although the prevalence of rheumatic heart disease (RHD) has fallen to less than 5% or so in the United States and Europe, it remains a significant problem in developing and low-income countries, with more than 1 million deaths per year, he noted. RHD patients typically present at younger ages, often with concomitant aortic regurgitation and mitral valve disease, but have less calcification than degenerative calcific aortic stenosis.
Commenting on the results, published in the Journal of the American College of Cardiology, David F. Williams, PhD, said in an interview that “it is only now becoming possible to entertain the use of TAVR in such patients, and this paper demonstrates the feasibility of doing so.
“Although the study is based on geriatric patients of an industrialized country, it opens the door to the massive unmet clinical needs in poorer regions as well as emerging economies,” said Dr. Williams, a professor at the Wake Forest Institute for Regenerative Medicine, Winston-Salem, N.C., and coauthor of an accompanying editorial.
The study included Medicare beneficiaries treated from October 2015 to December 2017 for rheumatic aortic stenosis (TAVR, n = 605; SAVR, n = 55) or nonrheumatic aortic stenosis (n = 88,554).
Among those with rheumatic disease, SAVR patients were younger than TAVR patients (73.4 vs. 79.4 years), had a lower prevalence of most comorbidities, and were less frail (median frailty score, 5.3 vs. 11.3).
SAVR was associated with significantly higher weighted risk for in-hospital acute kidney injury (22.3% vs. 11.9%), blood transfusion (19.8% vs. 7.6%), cardiogenic shock (5.7% vs. 1.5%), new-onset atrial fibrillation (21.1% vs. 2.2%), and had longer hospital stays (median, 8 vs. 3 days), whereas new permanent pacemaker implantations trended higher with TAVR (12.5% vs 7.2%).
The TAVR and SAVR groups had comparable rates of adjusted in-hospital mortality (2.4% vs. 3.5%), 30-day mortality (3.6% vs. 3.2%), 30-day stroke (2.4% vs. 2.8%), and 1-year mortality (13.1% vs. 8.9%).
Among the two TAVR cohorts, patients with rheumatic disease were younger than those with nonrheumatic aortic stenosis (79.4 vs. 81.2 years); had a higher prevalence of heart failure, ischemic stroke, atrial fibrillation, and lung disease; and were more frail (median score, 11.3 vs. 6.9).
Still, there was no difference in weighted risk of in-hospital mortality (2.2% vs. 2.6%), 30-day mortality (3.6% vs. 3.7%), 30-day stroke (2.0% vs. 3.3%), or 1-year mortality (16.0% vs. 17.1%) between TAVR patients with and without rheumatic stenosis.
“We didn’t have specific information on echo[cardiography], so we don’t know how that affected our results, but one of the encouraging points is that after a median follow-up of almost 2 years, none of the patients who had TAVR in the rheumatic valve and who survived required redo aortic valve replacement,” Dr. Mentias said. “It’s still short term but it shows that for the short to mid term, the valve is durable.”
Data were not available on paravalvular regurgitation, an Achilles heel for TAVR, but Dr. Mentias said rates of this complication have come down significantly in the past 2 years with modifications to newer-generation TAVR valves.
Dr. Williams and colleagues say one main limitation of the study also highlights the major shortcoming of contemporary TAVRs when treating patients with RHD: “namely, their inadequate suitability for AR [aortic regurgitation], the predominant rheumatic lesion of the aortic valve” in low- to middle-income countries.
They pointed out that patients needing an aortic valve where RHD is rampant are at least 30 years younger than the 79-year-old TAVR recipients in the study.
In a comment, Dr. Williams said there are several unanswered questions about the full impact TAVR could have in the treatment of young RHD patients in underprivileged regions. “These mainly concern the durability of the valves in individuals who could expect greater longevity than the typical heart valve patient in the USA, and the adaptation of transcatheter techniques to provide cost-effective treatment in regions that lack the usual sophisticated clinical infrastructure.”
Dr. Mentias received support from a National Research Service Award institutional grant to the Abboud Cardiovascular Research Center. Dr. Williams and coauthors are directors of Strait Access Technologies.
A version of this article first appeared on Medscape.com.
Patients with rheumatic heart disease (RHD) appear to have comparable outcomes, whether undergoing transcatheter or surgical aortic valve replacement (TAVR/SAVR), and when compared with TAVR in patients with nonrheumatic aortic stenosis, a new Medicare study finds.
An analysis of data from 1,159 Medicare beneficiaries with rheumatic aortic stenosis revealed that, over a median follow-up of 19 months, there was no difference in all-cause mortality with TAVR vs. SAVR (11.2 vs. 7.0 per 100 person-years; adjusted hazard ratio, 1.53; P = .2).
Mortality was also similar after a median follow-up of 17 months between TAVR in patients with rheumatic aortic stenosis and 88,554 additional beneficiaries with nonrheumatic aortic stenosis (15.2 vs. 17.7 deaths per 100 person-years; aHR, 0.87; P = .2).
“We need collaboration between industry and society leaders in developed countries to initiate a randomized, controlled trial to address the feasibility of TAVR in rheumatic heart disease in younger populations who aren’t surgical candidates or if there’s a lack of surgical capabilities in countries, but this is an encouraging first sign,” lead author Amgad Mentias, MD, MSc, Cleveland Clinic Foundation, said in an interview.
Although the prevalence of rheumatic heart disease (RHD) has fallen to less than 5% or so in the United States and Europe, it remains a significant problem in developing and low-income countries, with more than 1 million deaths per year, he noted. RHD patients typically present at younger ages, often with concomitant aortic regurgitation and mitral valve disease, but have less calcification than degenerative calcific aortic stenosis.
Commenting on the results, published in the Journal of the American College of Cardiology, David F. Williams, PhD, said in an interview that “it is only now becoming possible to entertain the use of TAVR in such patients, and this paper demonstrates the feasibility of doing so.
“Although the study is based on geriatric patients of an industrialized country, it opens the door to the massive unmet clinical needs in poorer regions as well as emerging economies,” said Dr. Williams, a professor at the Wake Forest Institute for Regenerative Medicine, Winston-Salem, N.C., and coauthor of an accompanying editorial.
The study included Medicare beneficiaries treated from October 2015 to December 2017 for rheumatic aortic stenosis (TAVR, n = 605; SAVR, n = 55) or nonrheumatic aortic stenosis (n = 88,554).
Among those with rheumatic disease, SAVR patients were younger than TAVR patients (73.4 vs. 79.4 years), had a lower prevalence of most comorbidities, and were less frail (median frailty score, 5.3 vs. 11.3).
SAVR was associated with significantly higher weighted risk for in-hospital acute kidney injury (22.3% vs. 11.9%), blood transfusion (19.8% vs. 7.6%), cardiogenic shock (5.7% vs. 1.5%), new-onset atrial fibrillation (21.1% vs. 2.2%), and had longer hospital stays (median, 8 vs. 3 days), whereas new permanent pacemaker implantations trended higher with TAVR (12.5% vs 7.2%).
The TAVR and SAVR groups had comparable rates of adjusted in-hospital mortality (2.4% vs. 3.5%), 30-day mortality (3.6% vs. 3.2%), 30-day stroke (2.4% vs. 2.8%), and 1-year mortality (13.1% vs. 8.9%).
Among the two TAVR cohorts, patients with rheumatic disease were younger than those with nonrheumatic aortic stenosis (79.4 vs. 81.2 years); had a higher prevalence of heart failure, ischemic stroke, atrial fibrillation, and lung disease; and were more frail (median score, 11.3 vs. 6.9).
Still, there was no difference in weighted risk of in-hospital mortality (2.2% vs. 2.6%), 30-day mortality (3.6% vs. 3.7%), 30-day stroke (2.0% vs. 3.3%), or 1-year mortality (16.0% vs. 17.1%) between TAVR patients with and without rheumatic stenosis.
“We didn’t have specific information on echo[cardiography], so we don’t know how that affected our results, but one of the encouraging points is that after a median follow-up of almost 2 years, none of the patients who had TAVR in the rheumatic valve and who survived required redo aortic valve replacement,” Dr. Mentias said. “It’s still short term but it shows that for the short to mid term, the valve is durable.”
Data were not available on paravalvular regurgitation, an Achilles heel for TAVR, but Dr. Mentias said rates of this complication have come down significantly in the past 2 years with modifications to newer-generation TAVR valves.
Dr. Williams and colleagues say one main limitation of the study also highlights the major shortcoming of contemporary TAVRs when treating patients with RHD: “namely, their inadequate suitability for AR [aortic regurgitation], the predominant rheumatic lesion of the aortic valve” in low- to middle-income countries.
They pointed out that patients needing an aortic valve where RHD is rampant are at least 30 years younger than the 79-year-old TAVR recipients in the study.
In a comment, Dr. Williams said there are several unanswered questions about the full impact TAVR could have in the treatment of young RHD patients in underprivileged regions. “These mainly concern the durability of the valves in individuals who could expect greater longevity than the typical heart valve patient in the USA, and the adaptation of transcatheter techniques to provide cost-effective treatment in regions that lack the usual sophisticated clinical infrastructure.”
Dr. Mentias received support from a National Research Service Award institutional grant to the Abboud Cardiovascular Research Center. Dr. Williams and coauthors are directors of Strait Access Technologies.
A version of this article first appeared on Medscape.com.
Dupilumab for the Treatment of Lichen Planus
To the Editor:
Lichen planus (LP) is an inflammatory mucocutaneous disorder that primarily affects adults aged 30 to 60 years.1 It can present across various regions such as the skin, scalp, oral cavity, genitalia, nails, and hair. It classically presents with pruritic, purple, polygonal papules or plaques. The proposed pathogenesis of this condition involves autoimmune destruction of epidermal basal keratinocytes.2 Management involves a stepwise approach, beginning with topical therapies such as corticosteroids and phototherapy and proceeding to systemic therapy including oral corticosteroids and retinoids. Additional medications with reported positive results include immunomodulators such as cyclosporine, tacrolimus, and mycophenolate mofetil.2-4 Dupilumab is a biologic immunomodulator and antagonist to the IL-4Rα on helper T cells (TH1). Although indicated for the treatment of moderate to severe atopic dermatitis, this medication’s immunomodulatory properties have been shown to aid various inflammatory cutaneous conditions, including prurigo nodularis.5-9 We present a case of dupilumab therapy for treatment-refractory LP.
A 52-year-old man presented with a new-onset progressive rash over the prior 6 months. He reported no history of atopic dermatitis. The patient described the rash as “severely pruritic” with a numeric rating scale itch intensity of 9/10 (0 being no itch; 10 being the worst itch imaginable). Physical examination revealed purple polygonal scaly papules on the arms, hands, legs, feet, chest, and back (Figure 1).
Three biopsies were taken, all indicative of lichenoid dermatitis consistent with LP. Rapid plasma reagin as well as HIV and hepatitis C virus serology tests were negative. Halobetasol ointment, tacrolimus ointment, and oral prednisone (28-day taper starting at 40 mg) all failed. Acitretin subsequently was initiated and failed to provide any benefit. The patient was unable to come to clinic 3 times a week for phototherapy due to his work schedule.
Due to the chronic, severe, and recalcitrant nature of his condition, as well as the lack of US Food and Drug Administration–approved treatments, the patient agreed to begin off-label treatment with dupilumab. Upon documentation, the patient’s primary diagnosis was listed as LP, clearly stating all commonly accepted treatments were attempted, except off-label therapy, and failed, and the plan was to treat him with dupilumab as if he had a severe form of atopic dermatitis. Dupilumab was approved with this documentation with a minimal co-pay, as the patient was on Medicaid. At 3-month follow-up (after 4 administrations of the medication), the patient showed remarkable improvement in appearance, and his numeric rating scale itch intensity score improved to 1/10.
Lichen planus is an immune-mediated, inflammatory condition that can affect the skin, hair, nails, and oral cavity. Although its etiology is not fully understood, research supports a primarily TH1 immunologic reaction.10 These T cells promote cytotoxic CD8 T-cell differentiation and migration, leading to subsequent destruction of epidermal basal keratinocytes. An important cytokine in this pathway—tumor necrosis factor α—stimulates a series of proinflammatory factors, including IL-1α, IL-8, and IL-6. IL-6 is of particular interest, as its elevation has been identified in the serum of patients with LP, with levels correlating to disease severity.11 This increase is thought to be multifactorial and a reliable predictor of disease activity.12,13 In addition to its proinflammatory role, IL-6 promotes the activity of IL-4, an essential cytokine in TH2 T-cell differentiation.
The TH2 pathway, enhanced by IL-6, increases the activity of downstream cytokines IL-4, IL-5, and IL-13. This pathway promotes IgE class switching and eosinophil maturation, pivotal factors in the development of atopic conditions such as allergic rhinitis, asthma, and atopic dermatitis. The role of IL-4 and TH2 cells in the pathogenesis of LP remains poorly understood.14 In prior basic laboratory studies, utilizing tissue sampling, RNA extraction, and real-time polymerase chain reaction assays, Yamauchi et al15 proposed that TH2-related chemokines played a pathogenic role in oral LP. Additional reports propose the pathogenic involvement of TH17, TH0, and TH2 T cells.16 These findings suggest that elevated IL-6 in those with LP may stimulate an increase in IL-4 and subsequent TH2 response. Dupilumab, a monoclonal antibody that targets IL-4Rα found on T cells, inhibits both IL-4 and IL-13 signaling, decreasing subsequent effector cell function.17,18 Several case reports have described dupilumab successfully treating various additional dermatoses, including prurigo nodularis, chronic pruritus, and bullous pemphigoid.5-9 Our case demonstrates an example of LP responsive to dupilumab. Our findings suggest that dupilumab interacts with the pathogenic cascade of LP, potentially implicating the role of TH2 in the pathophysiology of LP.
Treatment-refractory LP remains difficult to manage for both the patient and provider. Treatment regimens remain limited to small uncontrolled studies and case reports. Although primarily considered a TH1-mediated disease, the interplay of various alternative signaling pathways has been suggested. Our case of dupilumab-responsive LP suggests an underlying pathologic role of TH2-mediated activity. Dupilumab shows promise as an effective therapy for refractory LP, as evidenced by our patient’s remarkable response. Larger studies are warranted regarding the role of TH2-mediated inflammation and the use of dupilumab in LP.
- Cleach LL, Chosidow O. Clinical practice. lichen planus. N Engl J Med. 2012;266:723-732.
- Lehman, JS, Tollefson MM, Gibson LE. Lichen planus. Int J Dermatol. 2009;48:682-694.
- Frieling U, Bonsmann G, Schwarz T, et al. Treatment of severe lichen planus with mycophenolate mofetil. J Am Acad Dermatol. 2003;49:1063-1066.
- Cribier B, Frances C, Chosidow O. Treatment of lichen planus. an evidence-based medicine analysis of efficacy. Arch Dermatol. 1998;134:1521-1530.
- Calugareanu A, Jachiet C, Lepelletier C, et al. Dramatic improvement of generalized prurigo nodularis with dupilumab. J Eur Acad Dermatol Venereol. 2019;33:E303-E304.
- Kaye A, Gordon SC, Deverapalli SC, et al. Dupilumab for the treatment of recalcitrant bullous pemphigoid. JAMA Dermatol. 2018;154:1225-1226.
- Mollanazar NK, Qiu CC, Aldrich JL, et al. Use of dupilumab in HIV-positive patients: report of four cases. Br J Dermatol. 2019;181:1311-1312.
- Zhai LL, Savage KT, Qiu CC, et al. Chronic pruritus responding to dupilumab—a case series. Medicines (Basel). 2019;6:72.
- Mollanazar NK, Elgash M, Weaver L, et al. Reduced itch associated with dupilumab treatment in 4 patients with prurigo nodularis. JAMA Dermatol. 2019;155:121-122.
- Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting. part 1. viral infections and etiopathogenesis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100:40-51.
- Yin M, Li G, Song H, et al. Identifying the association between interleukin-6 and lichen planus: a meta-analysis. Biomed Rep. 2017;6:571-575.
- Sun A, Chia JS, Chang YF, et al. Serum interleukin-6 level is a useful marker in evaluating therapeutic effects of levamisole and Chinese medicinal herbs on patients with oral lichen planus. J Oral Pathol Med. 2002;31:196-203.
- Rhodus NL, Cheng B, Bowles W, et al. Proinflammatory cytokine levels in saliva before and after treatment of (erosive) oral lichen planus with dexamethasone. Oral Dis. 2006;12:112-116.
- Carrozzo M. Understanding the pathobiology of oral lichen planus. Curr Oral Health Rep. 2014;1:173-179.
- Yamauchi M, Moriyama M, Hayashida JN, et al. Myeloid dendritic cells stimulated by thymic stromal lymphopoietin promote Th2 immune responses and the pathogenesis of oral lichen planus. Plos One. 2017:12:e0173017.
- Piccinni M-P, Lombardell L, Logidice F, et al. Potential pathogenetic role of Th17, Th0, and Th2 cells in erosive and reticular oral lichen planus. Oral Dis. 2013:20:212-218.
- Kidd P. Th1/Th2 balance: the hypothesis, its limitations, and implications for health and disease. Altern Med Rev. 2003;8:223-246.
- Noda S, Kruefer JG, Guttum-Yassky E. The translational revolution and use of biologics in patients with inflammatory skin diseases. J Allergy Clin Immunol. 2015;135:324-336.
To the Editor:
Lichen planus (LP) is an inflammatory mucocutaneous disorder that primarily affects adults aged 30 to 60 years.1 It can present across various regions such as the skin, scalp, oral cavity, genitalia, nails, and hair. It classically presents with pruritic, purple, polygonal papules or plaques. The proposed pathogenesis of this condition involves autoimmune destruction of epidermal basal keratinocytes.2 Management involves a stepwise approach, beginning with topical therapies such as corticosteroids and phototherapy and proceeding to systemic therapy including oral corticosteroids and retinoids. Additional medications with reported positive results include immunomodulators such as cyclosporine, tacrolimus, and mycophenolate mofetil.2-4 Dupilumab is a biologic immunomodulator and antagonist to the IL-4Rα on helper T cells (TH1). Although indicated for the treatment of moderate to severe atopic dermatitis, this medication’s immunomodulatory properties have been shown to aid various inflammatory cutaneous conditions, including prurigo nodularis.5-9 We present a case of dupilumab therapy for treatment-refractory LP.
A 52-year-old man presented with a new-onset progressive rash over the prior 6 months. He reported no history of atopic dermatitis. The patient described the rash as “severely pruritic” with a numeric rating scale itch intensity of 9/10 (0 being no itch; 10 being the worst itch imaginable). Physical examination revealed purple polygonal scaly papules on the arms, hands, legs, feet, chest, and back (Figure 1).
Three biopsies were taken, all indicative of lichenoid dermatitis consistent with LP. Rapid plasma reagin as well as HIV and hepatitis C virus serology tests were negative. Halobetasol ointment, tacrolimus ointment, and oral prednisone (28-day taper starting at 40 mg) all failed. Acitretin subsequently was initiated and failed to provide any benefit. The patient was unable to come to clinic 3 times a week for phototherapy due to his work schedule.
Due to the chronic, severe, and recalcitrant nature of his condition, as well as the lack of US Food and Drug Administration–approved treatments, the patient agreed to begin off-label treatment with dupilumab. Upon documentation, the patient’s primary diagnosis was listed as LP, clearly stating all commonly accepted treatments were attempted, except off-label therapy, and failed, and the plan was to treat him with dupilumab as if he had a severe form of atopic dermatitis. Dupilumab was approved with this documentation with a minimal co-pay, as the patient was on Medicaid. At 3-month follow-up (after 4 administrations of the medication), the patient showed remarkable improvement in appearance, and his numeric rating scale itch intensity score improved to 1/10.
Lichen planus is an immune-mediated, inflammatory condition that can affect the skin, hair, nails, and oral cavity. Although its etiology is not fully understood, research supports a primarily TH1 immunologic reaction.10 These T cells promote cytotoxic CD8 T-cell differentiation and migration, leading to subsequent destruction of epidermal basal keratinocytes. An important cytokine in this pathway—tumor necrosis factor α—stimulates a series of proinflammatory factors, including IL-1α, IL-8, and IL-6. IL-6 is of particular interest, as its elevation has been identified in the serum of patients with LP, with levels correlating to disease severity.11 This increase is thought to be multifactorial and a reliable predictor of disease activity.12,13 In addition to its proinflammatory role, IL-6 promotes the activity of IL-4, an essential cytokine in TH2 T-cell differentiation.
The TH2 pathway, enhanced by IL-6, increases the activity of downstream cytokines IL-4, IL-5, and IL-13. This pathway promotes IgE class switching and eosinophil maturation, pivotal factors in the development of atopic conditions such as allergic rhinitis, asthma, and atopic dermatitis. The role of IL-4 and TH2 cells in the pathogenesis of LP remains poorly understood.14 In prior basic laboratory studies, utilizing tissue sampling, RNA extraction, and real-time polymerase chain reaction assays, Yamauchi et al15 proposed that TH2-related chemokines played a pathogenic role in oral LP. Additional reports propose the pathogenic involvement of TH17, TH0, and TH2 T cells.16 These findings suggest that elevated IL-6 in those with LP may stimulate an increase in IL-4 and subsequent TH2 response. Dupilumab, a monoclonal antibody that targets IL-4Rα found on T cells, inhibits both IL-4 and IL-13 signaling, decreasing subsequent effector cell function.17,18 Several case reports have described dupilumab successfully treating various additional dermatoses, including prurigo nodularis, chronic pruritus, and bullous pemphigoid.5-9 Our case demonstrates an example of LP responsive to dupilumab. Our findings suggest that dupilumab interacts with the pathogenic cascade of LP, potentially implicating the role of TH2 in the pathophysiology of LP.
Treatment-refractory LP remains difficult to manage for both the patient and provider. Treatment regimens remain limited to small uncontrolled studies and case reports. Although primarily considered a TH1-mediated disease, the interplay of various alternative signaling pathways has been suggested. Our case of dupilumab-responsive LP suggests an underlying pathologic role of TH2-mediated activity. Dupilumab shows promise as an effective therapy for refractory LP, as evidenced by our patient’s remarkable response. Larger studies are warranted regarding the role of TH2-mediated inflammation and the use of dupilumab in LP.
To the Editor:
Lichen planus (LP) is an inflammatory mucocutaneous disorder that primarily affects adults aged 30 to 60 years.1 It can present across various regions such as the skin, scalp, oral cavity, genitalia, nails, and hair. It classically presents with pruritic, purple, polygonal papules or plaques. The proposed pathogenesis of this condition involves autoimmune destruction of epidermal basal keratinocytes.2 Management involves a stepwise approach, beginning with topical therapies such as corticosteroids and phototherapy and proceeding to systemic therapy including oral corticosteroids and retinoids. Additional medications with reported positive results include immunomodulators such as cyclosporine, tacrolimus, and mycophenolate mofetil.2-4 Dupilumab is a biologic immunomodulator and antagonist to the IL-4Rα on helper T cells (TH1). Although indicated for the treatment of moderate to severe atopic dermatitis, this medication’s immunomodulatory properties have been shown to aid various inflammatory cutaneous conditions, including prurigo nodularis.5-9 We present a case of dupilumab therapy for treatment-refractory LP.
A 52-year-old man presented with a new-onset progressive rash over the prior 6 months. He reported no history of atopic dermatitis. The patient described the rash as “severely pruritic” with a numeric rating scale itch intensity of 9/10 (0 being no itch; 10 being the worst itch imaginable). Physical examination revealed purple polygonal scaly papules on the arms, hands, legs, feet, chest, and back (Figure 1).
Three biopsies were taken, all indicative of lichenoid dermatitis consistent with LP. Rapid plasma reagin as well as HIV and hepatitis C virus serology tests were negative. Halobetasol ointment, tacrolimus ointment, and oral prednisone (28-day taper starting at 40 mg) all failed. Acitretin subsequently was initiated and failed to provide any benefit. The patient was unable to come to clinic 3 times a week for phototherapy due to his work schedule.
Due to the chronic, severe, and recalcitrant nature of his condition, as well as the lack of US Food and Drug Administration–approved treatments, the patient agreed to begin off-label treatment with dupilumab. Upon documentation, the patient’s primary diagnosis was listed as LP, clearly stating all commonly accepted treatments were attempted, except off-label therapy, and failed, and the plan was to treat him with dupilumab as if he had a severe form of atopic dermatitis. Dupilumab was approved with this documentation with a minimal co-pay, as the patient was on Medicaid. At 3-month follow-up (after 4 administrations of the medication), the patient showed remarkable improvement in appearance, and his numeric rating scale itch intensity score improved to 1/10.
Lichen planus is an immune-mediated, inflammatory condition that can affect the skin, hair, nails, and oral cavity. Although its etiology is not fully understood, research supports a primarily TH1 immunologic reaction.10 These T cells promote cytotoxic CD8 T-cell differentiation and migration, leading to subsequent destruction of epidermal basal keratinocytes. An important cytokine in this pathway—tumor necrosis factor α—stimulates a series of proinflammatory factors, including IL-1α, IL-8, and IL-6. IL-6 is of particular interest, as its elevation has been identified in the serum of patients with LP, with levels correlating to disease severity.11 This increase is thought to be multifactorial and a reliable predictor of disease activity.12,13 In addition to its proinflammatory role, IL-6 promotes the activity of IL-4, an essential cytokine in TH2 T-cell differentiation.
The TH2 pathway, enhanced by IL-6, increases the activity of downstream cytokines IL-4, IL-5, and IL-13. This pathway promotes IgE class switching and eosinophil maturation, pivotal factors in the development of atopic conditions such as allergic rhinitis, asthma, and atopic dermatitis. The role of IL-4 and TH2 cells in the pathogenesis of LP remains poorly understood.14 In prior basic laboratory studies, utilizing tissue sampling, RNA extraction, and real-time polymerase chain reaction assays, Yamauchi et al15 proposed that TH2-related chemokines played a pathogenic role in oral LP. Additional reports propose the pathogenic involvement of TH17, TH0, and TH2 T cells.16 These findings suggest that elevated IL-6 in those with LP may stimulate an increase in IL-4 and subsequent TH2 response. Dupilumab, a monoclonal antibody that targets IL-4Rα found on T cells, inhibits both IL-4 and IL-13 signaling, decreasing subsequent effector cell function.17,18 Several case reports have described dupilumab successfully treating various additional dermatoses, including prurigo nodularis, chronic pruritus, and bullous pemphigoid.5-9 Our case demonstrates an example of LP responsive to dupilumab. Our findings suggest that dupilumab interacts with the pathogenic cascade of LP, potentially implicating the role of TH2 in the pathophysiology of LP.
Treatment-refractory LP remains difficult to manage for both the patient and provider. Treatment regimens remain limited to small uncontrolled studies and case reports. Although primarily considered a TH1-mediated disease, the interplay of various alternative signaling pathways has been suggested. Our case of dupilumab-responsive LP suggests an underlying pathologic role of TH2-mediated activity. Dupilumab shows promise as an effective therapy for refractory LP, as evidenced by our patient’s remarkable response. Larger studies are warranted regarding the role of TH2-mediated inflammation and the use of dupilumab in LP.
- Cleach LL, Chosidow O. Clinical practice. lichen planus. N Engl J Med. 2012;266:723-732.
- Lehman, JS, Tollefson MM, Gibson LE. Lichen planus. Int J Dermatol. 2009;48:682-694.
- Frieling U, Bonsmann G, Schwarz T, et al. Treatment of severe lichen planus with mycophenolate mofetil. J Am Acad Dermatol. 2003;49:1063-1066.
- Cribier B, Frances C, Chosidow O. Treatment of lichen planus. an evidence-based medicine analysis of efficacy. Arch Dermatol. 1998;134:1521-1530.
- Calugareanu A, Jachiet C, Lepelletier C, et al. Dramatic improvement of generalized prurigo nodularis with dupilumab. J Eur Acad Dermatol Venereol. 2019;33:E303-E304.
- Kaye A, Gordon SC, Deverapalli SC, et al. Dupilumab for the treatment of recalcitrant bullous pemphigoid. JAMA Dermatol. 2018;154:1225-1226.
- Mollanazar NK, Qiu CC, Aldrich JL, et al. Use of dupilumab in HIV-positive patients: report of four cases. Br J Dermatol. 2019;181:1311-1312.
- Zhai LL, Savage KT, Qiu CC, et al. Chronic pruritus responding to dupilumab—a case series. Medicines (Basel). 2019;6:72.
- Mollanazar NK, Elgash M, Weaver L, et al. Reduced itch associated with dupilumab treatment in 4 patients with prurigo nodularis. JAMA Dermatol. 2019;155:121-122.
- Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting. part 1. viral infections and etiopathogenesis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100:40-51.
- Yin M, Li G, Song H, et al. Identifying the association between interleukin-6 and lichen planus: a meta-analysis. Biomed Rep. 2017;6:571-575.
- Sun A, Chia JS, Chang YF, et al. Serum interleukin-6 level is a useful marker in evaluating therapeutic effects of levamisole and Chinese medicinal herbs on patients with oral lichen planus. J Oral Pathol Med. 2002;31:196-203.
- Rhodus NL, Cheng B, Bowles W, et al. Proinflammatory cytokine levels in saliva before and after treatment of (erosive) oral lichen planus with dexamethasone. Oral Dis. 2006;12:112-116.
- Carrozzo M. Understanding the pathobiology of oral lichen planus. Curr Oral Health Rep. 2014;1:173-179.
- Yamauchi M, Moriyama M, Hayashida JN, et al. Myeloid dendritic cells stimulated by thymic stromal lymphopoietin promote Th2 immune responses and the pathogenesis of oral lichen planus. Plos One. 2017:12:e0173017.
- Piccinni M-P, Lombardell L, Logidice F, et al. Potential pathogenetic role of Th17, Th0, and Th2 cells in erosive and reticular oral lichen planus. Oral Dis. 2013:20:212-218.
- Kidd P. Th1/Th2 balance: the hypothesis, its limitations, and implications for health and disease. Altern Med Rev. 2003;8:223-246.
- Noda S, Kruefer JG, Guttum-Yassky E. The translational revolution and use of biologics in patients with inflammatory skin diseases. J Allergy Clin Immunol. 2015;135:324-336.
- Cleach LL, Chosidow O. Clinical practice. lichen planus. N Engl J Med. 2012;266:723-732.
- Lehman, JS, Tollefson MM, Gibson LE. Lichen planus. Int J Dermatol. 2009;48:682-694.
- Frieling U, Bonsmann G, Schwarz T, et al. Treatment of severe lichen planus with mycophenolate mofetil. J Am Acad Dermatol. 2003;49:1063-1066.
- Cribier B, Frances C, Chosidow O. Treatment of lichen planus. an evidence-based medicine analysis of efficacy. Arch Dermatol. 1998;134:1521-1530.
- Calugareanu A, Jachiet C, Lepelletier C, et al. Dramatic improvement of generalized prurigo nodularis with dupilumab. J Eur Acad Dermatol Venereol. 2019;33:E303-E304.
- Kaye A, Gordon SC, Deverapalli SC, et al. Dupilumab for the treatment of recalcitrant bullous pemphigoid. JAMA Dermatol. 2018;154:1225-1226.
- Mollanazar NK, Qiu CC, Aldrich JL, et al. Use of dupilumab in HIV-positive patients: report of four cases. Br J Dermatol. 2019;181:1311-1312.
- Zhai LL, Savage KT, Qiu CC, et al. Chronic pruritus responding to dupilumab—a case series. Medicines (Basel). 2019;6:72.
- Mollanazar NK, Elgash M, Weaver L, et al. Reduced itch associated with dupilumab treatment in 4 patients with prurigo nodularis. JAMA Dermatol. 2019;155:121-122.
- Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting. part 1. viral infections and etiopathogenesis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100:40-51.
- Yin M, Li G, Song H, et al. Identifying the association between interleukin-6 and lichen planus: a meta-analysis. Biomed Rep. 2017;6:571-575.
- Sun A, Chia JS, Chang YF, et al. Serum interleukin-6 level is a useful marker in evaluating therapeutic effects of levamisole and Chinese medicinal herbs on patients with oral lichen planus. J Oral Pathol Med. 2002;31:196-203.
- Rhodus NL, Cheng B, Bowles W, et al. Proinflammatory cytokine levels in saliva before and after treatment of (erosive) oral lichen planus with dexamethasone. Oral Dis. 2006;12:112-116.
- Carrozzo M. Understanding the pathobiology of oral lichen planus. Curr Oral Health Rep. 2014;1:173-179.
- Yamauchi M, Moriyama M, Hayashida JN, et al. Myeloid dendritic cells stimulated by thymic stromal lymphopoietin promote Th2 immune responses and the pathogenesis of oral lichen planus. Plos One. 2017:12:e0173017.
- Piccinni M-P, Lombardell L, Logidice F, et al. Potential pathogenetic role of Th17, Th0, and Th2 cells in erosive and reticular oral lichen planus. Oral Dis. 2013:20:212-218.
- Kidd P. Th1/Th2 balance: the hypothesis, its limitations, and implications for health and disease. Altern Med Rev. 2003;8:223-246.
- Noda S, Kruefer JG, Guttum-Yassky E. The translational revolution and use of biologics in patients with inflammatory skin diseases. J Allergy Clin Immunol. 2015;135:324-336.
Practice Points
- Lichen planus (LP) is an inflammatory mucocutaneous disorder that can present across various regions of the body with pruritic, purple, polygonal papules or plaques.
- The proposed pathogenesis of LP involves autoimmune destruction of epidermal basal keratinocytes.
- The immunomodulatory properties of dupilumab have been shown to aid various inflammatory cutaneous conditions.
New guidelines on antibiotic prescribing focus on shorter courses
An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.
The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.
“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.
According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.
“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”
The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.
“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”
The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.
“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.
Another common reason is habit.
“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”
The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.
“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
Acute bronchitis with COPD exacerbations
Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.
Community-acquired pneumonia
The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.
Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
UTIs: Uncomplicated cystitis and pyelonephritis
For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.
This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
Cellulitis
MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.
This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
Continuing to get the message out
Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.
“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”
Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.
Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.
The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.
The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.
“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.
According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.
“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”
The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.
“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”
The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.
“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.
Another common reason is habit.
“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”
The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.
“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
Acute bronchitis with COPD exacerbations
Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.
Community-acquired pneumonia
The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.
Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
UTIs: Uncomplicated cystitis and pyelonephritis
For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.
This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
Cellulitis
MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.
This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
Continuing to get the message out
Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.
“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”
Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.
Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.
The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.
The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.
“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.
According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.
“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”
The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.
“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”
The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.
“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.
Another common reason is habit.
“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”
The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.
“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
Acute bronchitis with COPD exacerbations
Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.
Community-acquired pneumonia
The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.
Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
UTIs: Uncomplicated cystitis and pyelonephritis
For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.
This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
Cellulitis
MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.
This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
Continuing to get the message out
Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.
“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”
Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.
Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.
The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vesicles and Bullae on the Leg
The Diagnosis: Cutaneous B-cell Lymphoma
Histopathology revealed a dense and diffuse lymphocytic infiltrate throughout the dermis with occasional individual cell necrosis. On closer inspection, the infiltrate consisted of intermediate-sized lymphocytes, some with a vesiculated nucleus and ample amount of cytoplasm, while others contained hyperchromatic nuclei (Figure 1). These cells stained strongly positive for B-cell marker (CD20), while only a few mature lymphocytes demonstrated T-cell phenotype (CD3)(Figure 2).
Although the patient recounted a 3-month history of lower leg edema, he also reported that the rash began a few weeks after his diagnosis of systemic B-cell follicular lymphoma. Throughout this time, he was seen by various physicians who attributed the edema and skin changes to chronic stasis, peripheral venous insufficiency, and diabetic peripheral neuropathy. His primary care physician prescribed an antifungal lotion, which he discontinued on his own due to lack of improvement. Upon arrival to the emergency department, he was started on intravenous cefazolin and subcutaneous heparin. Doppler ultrasonography of the legs was ordered to rule out a deep venous thrombosis. Dermatology was consulted and proceeded with a punch biopsy to investigate for cutaneous B-cell lymphoma (BCL) with a plan to follow up as an outpatient for results upon discharge. He also was prescribed triamcinolone ointment 0.1% twice daily for symptomatic relief.
The patient's left axillary lymph node was biopsied for pathologic evaluation. Immunohistochemical staining revealed expression of B-cell markers CD20, CD79a, and PAX5, along with the antiapoptotic markers BCL-2 and BCL-6. Fluorescence in situ hybridization displayed gene rearrangements of BCL-2, BCL-6, and t(14;18)/IgH-BCL2 in the majority of cells. CD3 and CD5 immunostains were negative, indicating that T cells were not involved in this process. Flow cytometry identified a monoclonal κ B-cell population in 40% to 50% of the total cells, which co-expressed CD10, CD19, CD22, and CD38; the cells were negative for CD5, CD20, and CD23. Cell size was variably enlarged and CD71 positive, otherwise known as transferrin receptor 1, indicating the mediation of iron transport into cells of erythroid lineage that is necessary for proliferation.1 Bone marrow core biopsy did not identify features of bone marrow involvement by the lymphoma. Based on these results, the patient was diagnosed with systemic B-cell follicular lymphoma grade 3b stage IIIA. Oncology initiated a systemic chemotherapy regimen with obinutuzumab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone.
Skin involvement in B-cell follicular lymphoma can be primary or secondary. Although all subtypes of BCL can have secondary cutaneous involvement, it is most common in advanced-stage disease (stages III or IV).2 Cutaneous manifestations of primary cutaneous follicle-center lymphoma (PCFCL) and systemic/nodal follicular lymphoma secondarily involving the skin can be difficult to distinguish clinically and histopathologically; both appear as solitary or grouped plaques and nodules most commonly on the head, neck, or trunk, and rarely on the legs.3 Although the pathologic features of these two diagnoses can seem almost identical, it is important to differentiate them due to their differing prognosis and management. Patients with follicular lymphoma involving the skin are more likely than those with PCFCL to develop lymphadenopathy and B symptoms.3 Primary cutaneous follicle-center lymphoma also generally runs an indolent course and requires local therapy, while secondary involvement of the skin due to systemic/nodal follicular lymphoma has a worse prognosis and requires systemic chemotherapy treatment.4
Immunohistochemical markers are the most helpful tool used to distinguish PCFCL from systemic/nodal follicular lymphoma involving the skin. Tumors of B-cell origin are expected to express associated B-cell markers such as CD20, CD79a, and PAX52; BCL-6, a marker of germinal center cells, also is expected to stain positive.2 CD10 is positive in a majority of cases with a follicular growth pattern, while those with a diffuse pattern of growth may have a negative stain.2 The most valuable histopathologic indicator differentiating primary and secondary skin involvement is the intensity of BCL-2 expression.5 The prognostic significance of the t(14;18)/IgH-BCL2 rearrangement is controversial, with rearrangement identified in more than 75% of systemic/nodal follicular lymphoma cases and less commonly found in PCFCL, with one report arguing an incidence ranging from 1% to 40%.5
A comprehensive history and physical examination are necessary to develop a differential diagnosis. Our patient's lower leg edema and extensive medical history made the diagnosis more complicated. Pitting edema was present on physical examination, making elephantiasis nostras verrucosa less likely, as it would instead present with nonpitting edema and a woody feel.6 Our patient did not have epidemiologic exposure to filariasis through foreign travel and did not present with any classic signs or symptoms of lymphatic filariasis, such as fever, eosinophilia, chyluria, or hydrocele.7 Although a negative history of HIV makes Kaposi sarcoma and bacillary angiomatosis less likely diagnoses, a biopsy would be useful to rule out these conditions. Positive inguinal lymphadenopathy present on physical examination may have contributed to lymphatic flow obstruction leading to the leg lymphedema in our patient.
- Marsee DK, Pinkus GS, Yu H. CD71 (transferrin receptor): an effective marker for erythroid precursors in bone marrow biopsy specimens. Am J Clin Pathol. 2010;134:429-435.
- Jaffe ES. Navigating the cutaneous B-cell lymphomas: avoiding the rocky shoals. Mod Pathol. 2020;33(suppl 1):96-106.
- Skala SL, Hristov B, Hristov AC. Primary cutaneous follicle center lymphoma. Arch Pathol Lab Med. 2018;142:1313-1321.
- Suárez AL, Pulitzer M, Horwitz S, et al. Primary cutaneous B-cell lymphomas: part I. clinical features, diagnosis, and classification. J Am Acad Dermatol. 2013;69:329.e1-13; quiz 341-342.
- Servitje O, Climent F, Colomo L, et al. Primary cutaneous vs secondary cutaneous follicular lymphomas: a comparative study focused on BCL2, CD10, and t(14;18) expression. J Cutan Pathol. 2018;46:182-189.
- Fredman R, Tenenhaus M. Elephantiasis nostras verrucose [published online October 12, 2012]. Eplasty. 2012;12:ic14.
- Lourens GB, Ferrell DK. Lymphatic filariasis. Nurs Clin of North Am. 2019;54:181-192.
The Diagnosis: Cutaneous B-cell Lymphoma
Histopathology revealed a dense and diffuse lymphocytic infiltrate throughout the dermis with occasional individual cell necrosis. On closer inspection, the infiltrate consisted of intermediate-sized lymphocytes, some with a vesiculated nucleus and ample amount of cytoplasm, while others contained hyperchromatic nuclei (Figure 1). These cells stained strongly positive for B-cell marker (CD20), while only a few mature lymphocytes demonstrated T-cell phenotype (CD3)(Figure 2).
Although the patient recounted a 3-month history of lower leg edema, he also reported that the rash began a few weeks after his diagnosis of systemic B-cell follicular lymphoma. Throughout this time, he was seen by various physicians who attributed the edema and skin changes to chronic stasis, peripheral venous insufficiency, and diabetic peripheral neuropathy. His primary care physician prescribed an antifungal lotion, which he discontinued on his own due to lack of improvement. Upon arrival to the emergency department, he was started on intravenous cefazolin and subcutaneous heparin. Doppler ultrasonography of the legs was ordered to rule out a deep venous thrombosis. Dermatology was consulted and proceeded with a punch biopsy to investigate for cutaneous B-cell lymphoma (BCL) with a plan to follow up as an outpatient for results upon discharge. He also was prescribed triamcinolone ointment 0.1% twice daily for symptomatic relief.
The patient's left axillary lymph node was biopsied for pathologic evaluation. Immunohistochemical staining revealed expression of B-cell markers CD20, CD79a, and PAX5, along with the antiapoptotic markers BCL-2 and BCL-6. Fluorescence in situ hybridization displayed gene rearrangements of BCL-2, BCL-6, and t(14;18)/IgH-BCL2 in the majority of cells. CD3 and CD5 immunostains were negative, indicating that T cells were not involved in this process. Flow cytometry identified a monoclonal κ B-cell population in 40% to 50% of the total cells, which co-expressed CD10, CD19, CD22, and CD38; the cells were negative for CD5, CD20, and CD23. Cell size was variably enlarged and CD71 positive, otherwise known as transferrin receptor 1, indicating the mediation of iron transport into cells of erythroid lineage that is necessary for proliferation.1 Bone marrow core biopsy did not identify features of bone marrow involvement by the lymphoma. Based on these results, the patient was diagnosed with systemic B-cell follicular lymphoma grade 3b stage IIIA. Oncology initiated a systemic chemotherapy regimen with obinutuzumab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone.
Skin involvement in B-cell follicular lymphoma can be primary or secondary. Although all subtypes of BCL can have secondary cutaneous involvement, it is most common in advanced-stage disease (stages III or IV).2 Cutaneous manifestations of primary cutaneous follicle-center lymphoma (PCFCL) and systemic/nodal follicular lymphoma secondarily involving the skin can be difficult to distinguish clinically and histopathologically; both appear as solitary or grouped plaques and nodules most commonly on the head, neck, or trunk, and rarely on the legs.3 Although the pathologic features of these two diagnoses can seem almost identical, it is important to differentiate them due to their differing prognosis and management. Patients with follicular lymphoma involving the skin are more likely than those with PCFCL to develop lymphadenopathy and B symptoms.3 Primary cutaneous follicle-center lymphoma also generally runs an indolent course and requires local therapy, while secondary involvement of the skin due to systemic/nodal follicular lymphoma has a worse prognosis and requires systemic chemotherapy treatment.4
Immunohistochemical markers are the most helpful tool used to distinguish PCFCL from systemic/nodal follicular lymphoma involving the skin. Tumors of B-cell origin are expected to express associated B-cell markers such as CD20, CD79a, and PAX52; BCL-6, a marker of germinal center cells, also is expected to stain positive.2 CD10 is positive in a majority of cases with a follicular growth pattern, while those with a diffuse pattern of growth may have a negative stain.2 The most valuable histopathologic indicator differentiating primary and secondary skin involvement is the intensity of BCL-2 expression.5 The prognostic significance of the t(14;18)/IgH-BCL2 rearrangement is controversial, with rearrangement identified in more than 75% of systemic/nodal follicular lymphoma cases and less commonly found in PCFCL, with one report arguing an incidence ranging from 1% to 40%.5
A comprehensive history and physical examination are necessary to develop a differential diagnosis. Our patient's lower leg edema and extensive medical history made the diagnosis more complicated. Pitting edema was present on physical examination, making elephantiasis nostras verrucosa less likely, as it would instead present with nonpitting edema and a woody feel.6 Our patient did not have epidemiologic exposure to filariasis through foreign travel and did not present with any classic signs or symptoms of lymphatic filariasis, such as fever, eosinophilia, chyluria, or hydrocele.7 Although a negative history of HIV makes Kaposi sarcoma and bacillary angiomatosis less likely diagnoses, a biopsy would be useful to rule out these conditions. Positive inguinal lymphadenopathy present on physical examination may have contributed to lymphatic flow obstruction leading to the leg lymphedema in our patient.
The Diagnosis: Cutaneous B-cell Lymphoma
Histopathology revealed a dense and diffuse lymphocytic infiltrate throughout the dermis with occasional individual cell necrosis. On closer inspection, the infiltrate consisted of intermediate-sized lymphocytes, some with a vesiculated nucleus and ample amount of cytoplasm, while others contained hyperchromatic nuclei (Figure 1). These cells stained strongly positive for B-cell marker (CD20), while only a few mature lymphocytes demonstrated T-cell phenotype (CD3)(Figure 2).
Although the patient recounted a 3-month history of lower leg edema, he also reported that the rash began a few weeks after his diagnosis of systemic B-cell follicular lymphoma. Throughout this time, he was seen by various physicians who attributed the edema and skin changes to chronic stasis, peripheral venous insufficiency, and diabetic peripheral neuropathy. His primary care physician prescribed an antifungal lotion, which he discontinued on his own due to lack of improvement. Upon arrival to the emergency department, he was started on intravenous cefazolin and subcutaneous heparin. Doppler ultrasonography of the legs was ordered to rule out a deep venous thrombosis. Dermatology was consulted and proceeded with a punch biopsy to investigate for cutaneous B-cell lymphoma (BCL) with a plan to follow up as an outpatient for results upon discharge. He also was prescribed triamcinolone ointment 0.1% twice daily for symptomatic relief.
The patient's left axillary lymph node was biopsied for pathologic evaluation. Immunohistochemical staining revealed expression of B-cell markers CD20, CD79a, and PAX5, along with the antiapoptotic markers BCL-2 and BCL-6. Fluorescence in situ hybridization displayed gene rearrangements of BCL-2, BCL-6, and t(14;18)/IgH-BCL2 in the majority of cells. CD3 and CD5 immunostains were negative, indicating that T cells were not involved in this process. Flow cytometry identified a monoclonal κ B-cell population in 40% to 50% of the total cells, which co-expressed CD10, CD19, CD22, and CD38; the cells were negative for CD5, CD20, and CD23. Cell size was variably enlarged and CD71 positive, otherwise known as transferrin receptor 1, indicating the mediation of iron transport into cells of erythroid lineage that is necessary for proliferation.1 Bone marrow core biopsy did not identify features of bone marrow involvement by the lymphoma. Based on these results, the patient was diagnosed with systemic B-cell follicular lymphoma grade 3b stage IIIA. Oncology initiated a systemic chemotherapy regimen with obinutuzumab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone.
Skin involvement in B-cell follicular lymphoma can be primary or secondary. Although all subtypes of BCL can have secondary cutaneous involvement, it is most common in advanced-stage disease (stages III or IV).2 Cutaneous manifestations of primary cutaneous follicle-center lymphoma (PCFCL) and systemic/nodal follicular lymphoma secondarily involving the skin can be difficult to distinguish clinically and histopathologically; both appear as solitary or grouped plaques and nodules most commonly on the head, neck, or trunk, and rarely on the legs.3 Although the pathologic features of these two diagnoses can seem almost identical, it is important to differentiate them due to their differing prognosis and management. Patients with follicular lymphoma involving the skin are more likely than those with PCFCL to develop lymphadenopathy and B symptoms.3 Primary cutaneous follicle-center lymphoma also generally runs an indolent course and requires local therapy, while secondary involvement of the skin due to systemic/nodal follicular lymphoma has a worse prognosis and requires systemic chemotherapy treatment.4
Immunohistochemical markers are the most helpful tool used to distinguish PCFCL from systemic/nodal follicular lymphoma involving the skin. Tumors of B-cell origin are expected to express associated B-cell markers such as CD20, CD79a, and PAX52; BCL-6, a marker of germinal center cells, also is expected to stain positive.2 CD10 is positive in a majority of cases with a follicular growth pattern, while those with a diffuse pattern of growth may have a negative stain.2 The most valuable histopathologic indicator differentiating primary and secondary skin involvement is the intensity of BCL-2 expression.5 The prognostic significance of the t(14;18)/IgH-BCL2 rearrangement is controversial, with rearrangement identified in more than 75% of systemic/nodal follicular lymphoma cases and less commonly found in PCFCL, with one report arguing an incidence ranging from 1% to 40%.5
A comprehensive history and physical examination are necessary to develop a differential diagnosis. Our patient's lower leg edema and extensive medical history made the diagnosis more complicated. Pitting edema was present on physical examination, making elephantiasis nostras verrucosa less likely, as it would instead present with nonpitting edema and a woody feel.6 Our patient did not have epidemiologic exposure to filariasis through foreign travel and did not present with any classic signs or symptoms of lymphatic filariasis, such as fever, eosinophilia, chyluria, or hydrocele.7 Although a negative history of HIV makes Kaposi sarcoma and bacillary angiomatosis less likely diagnoses, a biopsy would be useful to rule out these conditions. Positive inguinal lymphadenopathy present on physical examination may have contributed to lymphatic flow obstruction leading to the leg lymphedema in our patient.
- Marsee DK, Pinkus GS, Yu H. CD71 (transferrin receptor): an effective marker for erythroid precursors in bone marrow biopsy specimens. Am J Clin Pathol. 2010;134:429-435.
- Jaffe ES. Navigating the cutaneous B-cell lymphomas: avoiding the rocky shoals. Mod Pathol. 2020;33(suppl 1):96-106.
- Skala SL, Hristov B, Hristov AC. Primary cutaneous follicle center lymphoma. Arch Pathol Lab Med. 2018;142:1313-1321.
- Suárez AL, Pulitzer M, Horwitz S, et al. Primary cutaneous B-cell lymphomas: part I. clinical features, diagnosis, and classification. J Am Acad Dermatol. 2013;69:329.e1-13; quiz 341-342.
- Servitje O, Climent F, Colomo L, et al. Primary cutaneous vs secondary cutaneous follicular lymphomas: a comparative study focused on BCL2, CD10, and t(14;18) expression. J Cutan Pathol. 2018;46:182-189.
- Fredman R, Tenenhaus M. Elephantiasis nostras verrucose [published online October 12, 2012]. Eplasty. 2012;12:ic14.
- Lourens GB, Ferrell DK. Lymphatic filariasis. Nurs Clin of North Am. 2019;54:181-192.
- Marsee DK, Pinkus GS, Yu H. CD71 (transferrin receptor): an effective marker for erythroid precursors in bone marrow biopsy specimens. Am J Clin Pathol. 2010;134:429-435.
- Jaffe ES. Navigating the cutaneous B-cell lymphomas: avoiding the rocky shoals. Mod Pathol. 2020;33(suppl 1):96-106.
- Skala SL, Hristov B, Hristov AC. Primary cutaneous follicle center lymphoma. Arch Pathol Lab Med. 2018;142:1313-1321.
- Suárez AL, Pulitzer M, Horwitz S, et al. Primary cutaneous B-cell lymphomas: part I. clinical features, diagnosis, and classification. J Am Acad Dermatol. 2013;69:329.e1-13; quiz 341-342.
- Servitje O, Climent F, Colomo L, et al. Primary cutaneous vs secondary cutaneous follicular lymphomas: a comparative study focused on BCL2, CD10, and t(14;18) expression. J Cutan Pathol. 2018;46:182-189.
- Fredman R, Tenenhaus M. Elephantiasis nostras verrucose [published online October 12, 2012]. Eplasty. 2012;12:ic14.
- Lourens GB, Ferrell DK. Lymphatic filariasis. Nurs Clin of North Am. 2019;54:181-192.
A 60-year-old man presented to the emergency department with slowly progressing edema of the lower legs of 3 months’ duration. In the week prior to presentation to the emergency department, he noticed a sudden eruption of vesicles and bullae on the right leg that drained clear fluid and healed with brown crust. The lesions were associated with mild burning, pruritus, and pain. He denied fever, chills, recent travel, or injury. His medical history was notable for poorly controlled diabetes mellitus, congestive heart failure, hypertension, chronic kidney disease, hyperlipidemia, and chronic anemia. Physical examination revealed multiple scattered erythematous vesicles and bullae on the right leg on a background of hyperpigmentation. Bilateral 2+ pitting edema of the legs also was present. A punch biopsy of a lesion was performed.
Hospital medicine around the world
Similar needs, local adaptations
Hospital medicine has evolved rapidly and spread widely across the United States in the past 25 years in response to the health care system’s needs for patient safety, quality, efficiency, and effective coordination of care in the ever-more complex environment of the acute care hospital.
But hospital care can be just as complex in other countries, so it’s not surprising that there’s a lot of interest around the world in the U.S. model of hospital medicine. But adaptations of that model vary across – and within – countries, reflecting local culture, health care systems, payment models, and approaches to medical education.
Other countries have looked to U.S. experts for consultations, to U.S.-trained doctors who might be willing to relocate, and to the Society of Hospital Medicine as an internationally focused source of networking and other resources. Some U.S.-based institutions, led by the Cleveland Clinic, Johns Hopkins Medicine, and Weill-Cornell Medical School, have established teaching outposts in other countries, with opportunities for resident training that prepares future hospitalists on the ground.
SHM CEO Eric E. Howell, MD, MHM, said that he personally has interacted with developing hospital medicine programs in six countries, who called upon him in part because of his past research on managing length of hospital stays. Dr. Howell counts himself among a few dozen U.S. hospitalists who are regularly invited to come and consult or to give talks to established or developing hospitalist programs in other countries. Because of the COVID-19 epidemic, in-person visits to other countries have largely been curtailed, but that has introduced a more virtual world of online meetings.
“I think the interesting thing about the ‘international consultants’ for hospital medicine is that while they come from professionally diverse backgrounds, they are all working to solve remarkably similar problems: How to make health care more affordable and higher quality while staying abreast of up-to-date best practice for physicians,” he said.
“Hospital care is costly no matter where you go. Other countries are also trying to limit expense in ways that don’t compromise the quality of that care,” Dr. Howell said. Also, hospitalized patients are more complex than ever, with increasing severity of illness and comorbidities, which makes having a hospitalist available on site more important.
Dr. Howell hopes to encourage more dialogue with international colleagues. SHM has established collaborations with medical societies in other countries and makes time at its conferences for international hospitalist participants to meet and share their experiences. Hospitalists from 33 countries were represented at SHM’s 2017 conference, and the upcoming virtual SHM Converge, May 3-7, 2021, includes a dedicated international session. SHM chapters have formed in a number of other countries.
Flora Kisuule, MD, MPH, SFHM, director of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center in Baltimore, said her international hospital medicine work1 started 7 years ago when she was invited to the Middle East to help Aramco, the Saudi Arabian Oil Company, develop a hospital medicine program based on the U.S. model for its employees. This was a joint venture with Johns Hopkins Medicine. “We went there and looked at their processes and made recommendations such as duration of hospitalist shifts and how to expand the footprint of hospital medicine in the hospital,” she said.
Then Dr. Kisuule was asked to help develop a hospital medicine program in Panama, where the drivers for developing hospital medicine were improving quality of care and ensuring patient safety. The biggest barrier has been remuneration and how to pay salaries that will allow doctors to work at only one hospital. In Panama, doctors typically work at multiple hospitals or clinics so they can earn enough to make ends meet.
The need for professional identity
Arpana Vidyarthi, MD, “grew up” professionally in hospital medicine at the University of California, San Francisco, a pioneering institution for hospital medicine, and in SHM. “We used to say: If you’ve seen one hospital medicine group, you’ve seen one hospital medicine group,” she said.
Dr. Vidyarthi went to Singapore in 2011, taking a job as a hospitalist at Singapore General Hospital and the affiliated Duke–National University Medical School, eventually directing the Division of Advanced Internal Medicine (general and hospital medicine) at the National University Health System, before moving back to UCSF in 2020.
“Professional identity is one of the biggest benefits hospital medicine can bestow in Singapore and across Asia, where general medicine is underdeveloped. Just as it did 20 years ago in the U.S., that professional identity offers a road map to achieving competency in practicing medicine in the hospital setting,” Dr. Vidyarthi said.
At UCSF, the professional identity of a hospitalist is broad but defined. The research agenda, quality, safety, and educational competencies are specific, seen through a system lens, she added. “We take pride in that professional identify. This is an opportunity for countries where general medicine is underdeveloped and undervalued.”
But the term hospital medicine – or the American model – isn’t always welcomed by health care systems in other countries, Dr Vidyarthi said. “The label of 'hospital medicine' brings people together in professional identify, and that professional identity opens doors. But for it to have legs in other countries, those skills need to be of value to the local system. It needs to make sense, as it did in the United States, and to add value for the identified gaps that need to be filled.”
In Singapore, the health care system turned to the model of acute medical units (AMUs) and the acute medicine physician specialty developed in the United Kingdom, which created a new way of delivering care, a new geography of care, and new set of competencies around which to build training and certification.
AMUs manage the majority of acute medical patients who present to the emergency department and get admitted, with initial treatment for a maximum of 72 hours. Acute physicians, trained in the specialty of assessment, diagnosis, and treatment of adult patients with urgent medical needs, work in a unit situated between the emergency department entrance and the specialty care units. This specialty has been recognized since 2009.2
“Acute medicine is the standard care model in the UK and is now found in all government hospitals in Singapore. This model is being adapted across Europe, Asia, and the Pacific Islands,” Dr. Vidyarthi said. “Advantages include the specific geography of the unit, and outcomes that are value-added to these systems such as decreased use of hospital beds in areas with very high bed occupancy rates.”
In many locales, a variety of titles are used to describe doctors who are not hospitalists as we understand them but whose work is based in the hospital, including house officer, duty officer, junior officer, registrar, or general practitioner. Often these hospital-based doctors, who may in fact be residents or nongraduated trainees, lack the training and the scope of practice of a hospitalist. Because they typically need to consult the supervising physician before making inpatient management decisions, they aren’t able to provide the timely response to the patient’s changing medical condition that is needed to manage today’s acute patients.
Defining the fee schedule
In South Korea, a hospitalist model has emerged since 2015 in response to the insufficient number of hospital-based physicians needed to cover all admitted patients and to address related issues of patient safety, health care quality, and limitations on total hours per week medical residents are allowed to work.
South Korea in 1989 adopted a universal National Health Insurance System (NHIS), which took 12 years to implement. But inadequate coverage for medical work in the hospital has deterred physicians from choosing to work there. South Korea had longer lengths of hospital stay, fewer practicing physicians per 1,000 patients, and a much higher number of hospital patients per practicing physician than other countries in the Organization for Economic Cooperation and Development, according to a new study in the Journal of Hospital Medicine detailing hospitalist development in South Korea.3
A council representing leading medical associations was formed to develop a South Korean hospitalist system and charged by the Ministry of Health with designing an official proposal for implementing it. A pilot study focused on quality and on defining a fee schedule for hospital work was tested in four hospitals, and then a second phase in 31 of South Korea’s 344 general hospitals tested the proposed fee schedule, said Wonjeong Chae, MPH, the first named author on the study, based in the Department of Public Health in the College of Medicine at Yonsei University in Seoul. “But we’re still working on making the fee schedule better,” she said.
Ms. Chae estimates that there are about 250 working hospitalists in South Korea today, which leaves a lot of gaps in practice. “We did learn from America, but we have a different system, so the American concept had to be adapted. Hospital medicine is still growing in Korea despite the impact of the pandemic. We are at the beginning stages of development, but we expect it will grow more with government support.”
In Brazil, a handful of hospital medicine pioneers such as Guilherme Barcellos, MD, SFHM, in Porto Alegre have tried to grow the hospitalist model, networking with colleagues across Latin America through the Pan American Society of Hospitalists and the Brazilian chapter of SHM.
Individual hospitals have developed hospitalist programs, but there is no national model to lead the way. Frequent turnover for the Minister of Health position has made it harder to develop consistent national policy, and the country is largely still in the early stages of developing hospital medicine, depending on isolated initiatives, as Dr. Barcellos described it in a November 2015 article in The Hospitalist.4 Growth is slow but continuing, with new programs such as the one led by Reginaldo Filho, MD at Hospital São Vicente in Curitiba standing out in the confrontation against COVID-19, Dr. Barcellos said.
What can we learn from others?
India-born, U.S.-trained hospitalist Anand Kartha, MD, MS, SFHM, currently heads the Hospital Medicine Program at Hamad General Hospital in Doha, Qatar. He moved from Boston to this small nation on the Arabian Peninsula in 2014. Under the leadership of the hospital’s Department of Medicine, this program was developed to address difficulties such as scheduling, transitions of care, and networking with home care and other providers – the same issues seen in hospitals around the world.
These are not novel problems, Dr. Kartha said, but all of them have a common solution in evidence-based practice. “As hospitalists, our key is to collaborate with everyone in the hospital, using the multidisciplinary approach that is a unique feature of hospital medicine.”
The model has continued to spread across hospitals in Qatar, including academic and community programs. “We now have a full-fledged academic hospitalist system, which collaborates with community hospitals and community programs including a women’s hospital and an oncologic hospital,” he said. “Now the focus is on expanding resource capacity and the internal pipeline for hospitalists. I am getting graduates from Weill Cornell Medicine in Qatar.” Another key collaborator has been the Boston-based Institute for Healthcare Improvement, helping to develop best practices in Qatar and sponsoring the annual Middle East Forum on Quality and Safety in Health Care.
The residency training program at Hamad General is accredited by ACGME, with the same expected competencies as in the U.S. “We don’t use the term ‘hospitalist,’ ” Dr. Kartha said. “It’s better to focus on the model of care – which clearly was American. That model has encountered some resistance in some countries – on many of the same grounds U.S. hospitalists faced 20 years ago. You have to be sensitive to local culture. For hospitalists to succeed internationally, they have to possess a high degree of cultural intelligence.” There’s no shortage of issues such as language barriers, he said. “But that’s no different than at Boston Medical Center.”
SHM’s Middle East Chapter was off to a great start and then was slowed down by regional politics and COVID-19, but is looking forward to a great reboot in 2021, Dr. Kartha said. The pandemic also has been an opportunity to show how hospital medicine is the backbone of the hospital’s ability to respond, although of course many other professionals also pitched in.
Other countries around the world have learned a lot from the American model of hospital medicine. But sources for this article wonder if U.S. hospitalists, in turn, could learn from their adaptations and innovations.
“We can all learn better how to practice our field of medicine in the hospital with less resource utilization,” Dr. Vidyarthi concluded. “So many innovations are happening around us. If we open our eyes to our global colleagues and infuse some of their ideas, it could be wonderful for hospital professionals in the United States.”
References
1. Kisuule F, Howell E. Hospital medicine beyond the United States. Int J Gen Med. 2018;11:65-71. doi: 10.2147/IJGM.S151275.
2. Stosic J et al. The acute physician: The future of acute hospital care in the UK. Clin Med (Lond). 2010 Apr; 10(2):145-7. doi: 10.7861/clinmedicine.10-2-145.
3. Yan Y et al. Adoption of Hospitalist Care in Asia: Experiences From Singapore, Taiwan, Korea, and Japan. J Hosp Med. Published Online First 2021 June 11. doi: 10.12788/jhm.3621.
4. Beresford L. Hospital medicine flourishing around the world. The Hospitalist. Nov 2015.
Similar needs, local adaptations
Similar needs, local adaptations
Hospital medicine has evolved rapidly and spread widely across the United States in the past 25 years in response to the health care system’s needs for patient safety, quality, efficiency, and effective coordination of care in the ever-more complex environment of the acute care hospital.
But hospital care can be just as complex in other countries, so it’s not surprising that there’s a lot of interest around the world in the U.S. model of hospital medicine. But adaptations of that model vary across – and within – countries, reflecting local culture, health care systems, payment models, and approaches to medical education.
Other countries have looked to U.S. experts for consultations, to U.S.-trained doctors who might be willing to relocate, and to the Society of Hospital Medicine as an internationally focused source of networking and other resources. Some U.S.-based institutions, led by the Cleveland Clinic, Johns Hopkins Medicine, and Weill-Cornell Medical School, have established teaching outposts in other countries, with opportunities for resident training that prepares future hospitalists on the ground.
SHM CEO Eric E. Howell, MD, MHM, said that he personally has interacted with developing hospital medicine programs in six countries, who called upon him in part because of his past research on managing length of hospital stays. Dr. Howell counts himself among a few dozen U.S. hospitalists who are regularly invited to come and consult or to give talks to established or developing hospitalist programs in other countries. Because of the COVID-19 epidemic, in-person visits to other countries have largely been curtailed, but that has introduced a more virtual world of online meetings.
“I think the interesting thing about the ‘international consultants’ for hospital medicine is that while they come from professionally diverse backgrounds, they are all working to solve remarkably similar problems: How to make health care more affordable and higher quality while staying abreast of up-to-date best practice for physicians,” he said.
“Hospital care is costly no matter where you go. Other countries are also trying to limit expense in ways that don’t compromise the quality of that care,” Dr. Howell said. Also, hospitalized patients are more complex than ever, with increasing severity of illness and comorbidities, which makes having a hospitalist available on site more important.
Dr. Howell hopes to encourage more dialogue with international colleagues. SHM has established collaborations with medical societies in other countries and makes time at its conferences for international hospitalist participants to meet and share their experiences. Hospitalists from 33 countries were represented at SHM’s 2017 conference, and the upcoming virtual SHM Converge, May 3-7, 2021, includes a dedicated international session. SHM chapters have formed in a number of other countries.
Flora Kisuule, MD, MPH, SFHM, director of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center in Baltimore, said her international hospital medicine work1 started 7 years ago when she was invited to the Middle East to help Aramco, the Saudi Arabian Oil Company, develop a hospital medicine program based on the U.S. model for its employees. This was a joint venture with Johns Hopkins Medicine. “We went there and looked at their processes and made recommendations such as duration of hospitalist shifts and how to expand the footprint of hospital medicine in the hospital,” she said.
Then Dr. Kisuule was asked to help develop a hospital medicine program in Panama, where the drivers for developing hospital medicine were improving quality of care and ensuring patient safety. The biggest barrier has been remuneration and how to pay salaries that will allow doctors to work at only one hospital. In Panama, doctors typically work at multiple hospitals or clinics so they can earn enough to make ends meet.
The need for professional identity
Arpana Vidyarthi, MD, “grew up” professionally in hospital medicine at the University of California, San Francisco, a pioneering institution for hospital medicine, and in SHM. “We used to say: If you’ve seen one hospital medicine group, you’ve seen one hospital medicine group,” she said.
Dr. Vidyarthi went to Singapore in 2011, taking a job as a hospitalist at Singapore General Hospital and the affiliated Duke–National University Medical School, eventually directing the Division of Advanced Internal Medicine (general and hospital medicine) at the National University Health System, before moving back to UCSF in 2020.
“Professional identity is one of the biggest benefits hospital medicine can bestow in Singapore and across Asia, where general medicine is underdeveloped. Just as it did 20 years ago in the U.S., that professional identity offers a road map to achieving competency in practicing medicine in the hospital setting,” Dr. Vidyarthi said.
At UCSF, the professional identity of a hospitalist is broad but defined. The research agenda, quality, safety, and educational competencies are specific, seen through a system lens, she added. “We take pride in that professional identify. This is an opportunity for countries where general medicine is underdeveloped and undervalued.”
But the term hospital medicine – or the American model – isn’t always welcomed by health care systems in other countries, Dr Vidyarthi said. “The label of 'hospital medicine' brings people together in professional identify, and that professional identity opens doors. But for it to have legs in other countries, those skills need to be of value to the local system. It needs to make sense, as it did in the United States, and to add value for the identified gaps that need to be filled.”
In Singapore, the health care system turned to the model of acute medical units (AMUs) and the acute medicine physician specialty developed in the United Kingdom, which created a new way of delivering care, a new geography of care, and new set of competencies around which to build training and certification.
AMUs manage the majority of acute medical patients who present to the emergency department and get admitted, with initial treatment for a maximum of 72 hours. Acute physicians, trained in the specialty of assessment, diagnosis, and treatment of adult patients with urgent medical needs, work in a unit situated between the emergency department entrance and the specialty care units. This specialty has been recognized since 2009.2
“Acute medicine is the standard care model in the UK and is now found in all government hospitals in Singapore. This model is being adapted across Europe, Asia, and the Pacific Islands,” Dr. Vidyarthi said. “Advantages include the specific geography of the unit, and outcomes that are value-added to these systems such as decreased use of hospital beds in areas with very high bed occupancy rates.”
In many locales, a variety of titles are used to describe doctors who are not hospitalists as we understand them but whose work is based in the hospital, including house officer, duty officer, junior officer, registrar, or general practitioner. Often these hospital-based doctors, who may in fact be residents or nongraduated trainees, lack the training and the scope of practice of a hospitalist. Because they typically need to consult the supervising physician before making inpatient management decisions, they aren’t able to provide the timely response to the patient’s changing medical condition that is needed to manage today’s acute patients.
Defining the fee schedule
In South Korea, a hospitalist model has emerged since 2015 in response to the insufficient number of hospital-based physicians needed to cover all admitted patients and to address related issues of patient safety, health care quality, and limitations on total hours per week medical residents are allowed to work.
South Korea in 1989 adopted a universal National Health Insurance System (NHIS), which took 12 years to implement. But inadequate coverage for medical work in the hospital has deterred physicians from choosing to work there. South Korea had longer lengths of hospital stay, fewer practicing physicians per 1,000 patients, and a much higher number of hospital patients per practicing physician than other countries in the Organization for Economic Cooperation and Development, according to a new study in the Journal of Hospital Medicine detailing hospitalist development in South Korea.3
A council representing leading medical associations was formed to develop a South Korean hospitalist system and charged by the Ministry of Health with designing an official proposal for implementing it. A pilot study focused on quality and on defining a fee schedule for hospital work was tested in four hospitals, and then a second phase in 31 of South Korea’s 344 general hospitals tested the proposed fee schedule, said Wonjeong Chae, MPH, the first named author on the study, based in the Department of Public Health in the College of Medicine at Yonsei University in Seoul. “But we’re still working on making the fee schedule better,” she said.
Ms. Chae estimates that there are about 250 working hospitalists in South Korea today, which leaves a lot of gaps in practice. “We did learn from America, but we have a different system, so the American concept had to be adapted. Hospital medicine is still growing in Korea despite the impact of the pandemic. We are at the beginning stages of development, but we expect it will grow more with government support.”
In Brazil, a handful of hospital medicine pioneers such as Guilherme Barcellos, MD, SFHM, in Porto Alegre have tried to grow the hospitalist model, networking with colleagues across Latin America through the Pan American Society of Hospitalists and the Brazilian chapter of SHM.
Individual hospitals have developed hospitalist programs, but there is no national model to lead the way. Frequent turnover for the Minister of Health position has made it harder to develop consistent national policy, and the country is largely still in the early stages of developing hospital medicine, depending on isolated initiatives, as Dr. Barcellos described it in a November 2015 article in The Hospitalist.4 Growth is slow but continuing, with new programs such as the one led by Reginaldo Filho, MD at Hospital São Vicente in Curitiba standing out in the confrontation against COVID-19, Dr. Barcellos said.
What can we learn from others?
India-born, U.S.-trained hospitalist Anand Kartha, MD, MS, SFHM, currently heads the Hospital Medicine Program at Hamad General Hospital in Doha, Qatar. He moved from Boston to this small nation on the Arabian Peninsula in 2014. Under the leadership of the hospital’s Department of Medicine, this program was developed to address difficulties such as scheduling, transitions of care, and networking with home care and other providers – the same issues seen in hospitals around the world.
These are not novel problems, Dr. Kartha said, but all of them have a common solution in evidence-based practice. “As hospitalists, our key is to collaborate with everyone in the hospital, using the multidisciplinary approach that is a unique feature of hospital medicine.”
The model has continued to spread across hospitals in Qatar, including academic and community programs. “We now have a full-fledged academic hospitalist system, which collaborates with community hospitals and community programs including a women’s hospital and an oncologic hospital,” he said. “Now the focus is on expanding resource capacity and the internal pipeline for hospitalists. I am getting graduates from Weill Cornell Medicine in Qatar.” Another key collaborator has been the Boston-based Institute for Healthcare Improvement, helping to develop best practices in Qatar and sponsoring the annual Middle East Forum on Quality and Safety in Health Care.
The residency training program at Hamad General is accredited by ACGME, with the same expected competencies as in the U.S. “We don’t use the term ‘hospitalist,’ ” Dr. Kartha said. “It’s better to focus on the model of care – which clearly was American. That model has encountered some resistance in some countries – on many of the same grounds U.S. hospitalists faced 20 years ago. You have to be sensitive to local culture. For hospitalists to succeed internationally, they have to possess a high degree of cultural intelligence.” There’s no shortage of issues such as language barriers, he said. “But that’s no different than at Boston Medical Center.”
SHM’s Middle East Chapter was off to a great start and then was slowed down by regional politics and COVID-19, but is looking forward to a great reboot in 2021, Dr. Kartha said. The pandemic also has been an opportunity to show how hospital medicine is the backbone of the hospital’s ability to respond, although of course many other professionals also pitched in.
Other countries around the world have learned a lot from the American model of hospital medicine. But sources for this article wonder if U.S. hospitalists, in turn, could learn from their adaptations and innovations.
“We can all learn better how to practice our field of medicine in the hospital with less resource utilization,” Dr. Vidyarthi concluded. “So many innovations are happening around us. If we open our eyes to our global colleagues and infuse some of their ideas, it could be wonderful for hospital professionals in the United States.”
References
1. Kisuule F, Howell E. Hospital medicine beyond the United States. Int J Gen Med. 2018;11:65-71. doi: 10.2147/IJGM.S151275.
2. Stosic J et al. The acute physician: The future of acute hospital care in the UK. Clin Med (Lond). 2010 Apr; 10(2):145-7. doi: 10.7861/clinmedicine.10-2-145.
3. Yan Y et al. Adoption of Hospitalist Care in Asia: Experiences From Singapore, Taiwan, Korea, and Japan. J Hosp Med. Published Online First 2021 June 11. doi: 10.12788/jhm.3621.
4. Beresford L. Hospital medicine flourishing around the world. The Hospitalist. Nov 2015.
Hospital medicine has evolved rapidly and spread widely across the United States in the past 25 years in response to the health care system’s needs for patient safety, quality, efficiency, and effective coordination of care in the ever-more complex environment of the acute care hospital.
But hospital care can be just as complex in other countries, so it’s not surprising that there’s a lot of interest around the world in the U.S. model of hospital medicine. But adaptations of that model vary across – and within – countries, reflecting local culture, health care systems, payment models, and approaches to medical education.
Other countries have looked to U.S. experts for consultations, to U.S.-trained doctors who might be willing to relocate, and to the Society of Hospital Medicine as an internationally focused source of networking and other resources. Some U.S.-based institutions, led by the Cleveland Clinic, Johns Hopkins Medicine, and Weill-Cornell Medical School, have established teaching outposts in other countries, with opportunities for resident training that prepares future hospitalists on the ground.
SHM CEO Eric E. Howell, MD, MHM, said that he personally has interacted with developing hospital medicine programs in six countries, who called upon him in part because of his past research on managing length of hospital stays. Dr. Howell counts himself among a few dozen U.S. hospitalists who are regularly invited to come and consult or to give talks to established or developing hospitalist programs in other countries. Because of the COVID-19 epidemic, in-person visits to other countries have largely been curtailed, but that has introduced a more virtual world of online meetings.
“I think the interesting thing about the ‘international consultants’ for hospital medicine is that while they come from professionally diverse backgrounds, they are all working to solve remarkably similar problems: How to make health care more affordable and higher quality while staying abreast of up-to-date best practice for physicians,” he said.
“Hospital care is costly no matter where you go. Other countries are also trying to limit expense in ways that don’t compromise the quality of that care,” Dr. Howell said. Also, hospitalized patients are more complex than ever, with increasing severity of illness and comorbidities, which makes having a hospitalist available on site more important.
Dr. Howell hopes to encourage more dialogue with international colleagues. SHM has established collaborations with medical societies in other countries and makes time at its conferences for international hospitalist participants to meet and share their experiences. Hospitalists from 33 countries were represented at SHM’s 2017 conference, and the upcoming virtual SHM Converge, May 3-7, 2021, includes a dedicated international session. SHM chapters have formed in a number of other countries.
Flora Kisuule, MD, MPH, SFHM, director of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center in Baltimore, said her international hospital medicine work1 started 7 years ago when she was invited to the Middle East to help Aramco, the Saudi Arabian Oil Company, develop a hospital medicine program based on the U.S. model for its employees. This was a joint venture with Johns Hopkins Medicine. “We went there and looked at their processes and made recommendations such as duration of hospitalist shifts and how to expand the footprint of hospital medicine in the hospital,” she said.
Then Dr. Kisuule was asked to help develop a hospital medicine program in Panama, where the drivers for developing hospital medicine were improving quality of care and ensuring patient safety. The biggest barrier has been remuneration and how to pay salaries that will allow doctors to work at only one hospital. In Panama, doctors typically work at multiple hospitals or clinics so they can earn enough to make ends meet.
The need for professional identity
Arpana Vidyarthi, MD, “grew up” professionally in hospital medicine at the University of California, San Francisco, a pioneering institution for hospital medicine, and in SHM. “We used to say: If you’ve seen one hospital medicine group, you’ve seen one hospital medicine group,” she said.
Dr. Vidyarthi went to Singapore in 2011, taking a job as a hospitalist at Singapore General Hospital and the affiliated Duke–National University Medical School, eventually directing the Division of Advanced Internal Medicine (general and hospital medicine) at the National University Health System, before moving back to UCSF in 2020.
“Professional identity is one of the biggest benefits hospital medicine can bestow in Singapore and across Asia, where general medicine is underdeveloped. Just as it did 20 years ago in the U.S., that professional identity offers a road map to achieving competency in practicing medicine in the hospital setting,” Dr. Vidyarthi said.
At UCSF, the professional identity of a hospitalist is broad but defined. The research agenda, quality, safety, and educational competencies are specific, seen through a system lens, she added. “We take pride in that professional identify. This is an opportunity for countries where general medicine is underdeveloped and undervalued.”
But the term hospital medicine – or the American model – isn’t always welcomed by health care systems in other countries, Dr Vidyarthi said. “The label of 'hospital medicine' brings people together in professional identify, and that professional identity opens doors. But for it to have legs in other countries, those skills need to be of value to the local system. It needs to make sense, as it did in the United States, and to add value for the identified gaps that need to be filled.”
In Singapore, the health care system turned to the model of acute medical units (AMUs) and the acute medicine physician specialty developed in the United Kingdom, which created a new way of delivering care, a new geography of care, and new set of competencies around which to build training and certification.
AMUs manage the majority of acute medical patients who present to the emergency department and get admitted, with initial treatment for a maximum of 72 hours. Acute physicians, trained in the specialty of assessment, diagnosis, and treatment of adult patients with urgent medical needs, work in a unit situated between the emergency department entrance and the specialty care units. This specialty has been recognized since 2009.2
“Acute medicine is the standard care model in the UK and is now found in all government hospitals in Singapore. This model is being adapted across Europe, Asia, and the Pacific Islands,” Dr. Vidyarthi said. “Advantages include the specific geography of the unit, and outcomes that are value-added to these systems such as decreased use of hospital beds in areas with very high bed occupancy rates.”
In many locales, a variety of titles are used to describe doctors who are not hospitalists as we understand them but whose work is based in the hospital, including house officer, duty officer, junior officer, registrar, or general practitioner. Often these hospital-based doctors, who may in fact be residents or nongraduated trainees, lack the training and the scope of practice of a hospitalist. Because they typically need to consult the supervising physician before making inpatient management decisions, they aren’t able to provide the timely response to the patient’s changing medical condition that is needed to manage today’s acute patients.
Defining the fee schedule
In South Korea, a hospitalist model has emerged since 2015 in response to the insufficient number of hospital-based physicians needed to cover all admitted patients and to address related issues of patient safety, health care quality, and limitations on total hours per week medical residents are allowed to work.
South Korea in 1989 adopted a universal National Health Insurance System (NHIS), which took 12 years to implement. But inadequate coverage for medical work in the hospital has deterred physicians from choosing to work there. South Korea had longer lengths of hospital stay, fewer practicing physicians per 1,000 patients, and a much higher number of hospital patients per practicing physician than other countries in the Organization for Economic Cooperation and Development, according to a new study in the Journal of Hospital Medicine detailing hospitalist development in South Korea.3
A council representing leading medical associations was formed to develop a South Korean hospitalist system and charged by the Ministry of Health with designing an official proposal for implementing it. A pilot study focused on quality and on defining a fee schedule for hospital work was tested in four hospitals, and then a second phase in 31 of South Korea’s 344 general hospitals tested the proposed fee schedule, said Wonjeong Chae, MPH, the first named author on the study, based in the Department of Public Health in the College of Medicine at Yonsei University in Seoul. “But we’re still working on making the fee schedule better,” she said.
Ms. Chae estimates that there are about 250 working hospitalists in South Korea today, which leaves a lot of gaps in practice. “We did learn from America, but we have a different system, so the American concept had to be adapted. Hospital medicine is still growing in Korea despite the impact of the pandemic. We are at the beginning stages of development, but we expect it will grow more with government support.”
In Brazil, a handful of hospital medicine pioneers such as Guilherme Barcellos, MD, SFHM, in Porto Alegre have tried to grow the hospitalist model, networking with colleagues across Latin America through the Pan American Society of Hospitalists and the Brazilian chapter of SHM.
Individual hospitals have developed hospitalist programs, but there is no national model to lead the way. Frequent turnover for the Minister of Health position has made it harder to develop consistent national policy, and the country is largely still in the early stages of developing hospital medicine, depending on isolated initiatives, as Dr. Barcellos described it in a November 2015 article in The Hospitalist.4 Growth is slow but continuing, with new programs such as the one led by Reginaldo Filho, MD at Hospital São Vicente in Curitiba standing out in the confrontation against COVID-19, Dr. Barcellos said.
What can we learn from others?
India-born, U.S.-trained hospitalist Anand Kartha, MD, MS, SFHM, currently heads the Hospital Medicine Program at Hamad General Hospital in Doha, Qatar. He moved from Boston to this small nation on the Arabian Peninsula in 2014. Under the leadership of the hospital’s Department of Medicine, this program was developed to address difficulties such as scheduling, transitions of care, and networking with home care and other providers – the same issues seen in hospitals around the world.
These are not novel problems, Dr. Kartha said, but all of them have a common solution in evidence-based practice. “As hospitalists, our key is to collaborate with everyone in the hospital, using the multidisciplinary approach that is a unique feature of hospital medicine.”
The model has continued to spread across hospitals in Qatar, including academic and community programs. “We now have a full-fledged academic hospitalist system, which collaborates with community hospitals and community programs including a women’s hospital and an oncologic hospital,” he said. “Now the focus is on expanding resource capacity and the internal pipeline for hospitalists. I am getting graduates from Weill Cornell Medicine in Qatar.” Another key collaborator has been the Boston-based Institute for Healthcare Improvement, helping to develop best practices in Qatar and sponsoring the annual Middle East Forum on Quality and Safety in Health Care.
The residency training program at Hamad General is accredited by ACGME, with the same expected competencies as in the U.S. “We don’t use the term ‘hospitalist,’ ” Dr. Kartha said. “It’s better to focus on the model of care – which clearly was American. That model has encountered some resistance in some countries – on many of the same grounds U.S. hospitalists faced 20 years ago. You have to be sensitive to local culture. For hospitalists to succeed internationally, they have to possess a high degree of cultural intelligence.” There’s no shortage of issues such as language barriers, he said. “But that’s no different than at Boston Medical Center.”
SHM’s Middle East Chapter was off to a great start and then was slowed down by regional politics and COVID-19, but is looking forward to a great reboot in 2021, Dr. Kartha said. The pandemic also has been an opportunity to show how hospital medicine is the backbone of the hospital’s ability to respond, although of course many other professionals also pitched in.
Other countries around the world have learned a lot from the American model of hospital medicine. But sources for this article wonder if U.S. hospitalists, in turn, could learn from their adaptations and innovations.
“We can all learn better how to practice our field of medicine in the hospital with less resource utilization,” Dr. Vidyarthi concluded. “So many innovations are happening around us. If we open our eyes to our global colleagues and infuse some of their ideas, it could be wonderful for hospital professionals in the United States.”
References
1. Kisuule F, Howell E. Hospital medicine beyond the United States. Int J Gen Med. 2018;11:65-71. doi: 10.2147/IJGM.S151275.
2. Stosic J et al. The acute physician: The future of acute hospital care in the UK. Clin Med (Lond). 2010 Apr; 10(2):145-7. doi: 10.7861/clinmedicine.10-2-145.
3. Yan Y et al. Adoption of Hospitalist Care in Asia: Experiences From Singapore, Taiwan, Korea, and Japan. J Hosp Med. Published Online First 2021 June 11. doi: 10.12788/jhm.3621.
4. Beresford L. Hospital medicine flourishing around the world. The Hospitalist. Nov 2015.
FDA okays new indication for alirocumab in homozygous FH
The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.
The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).
Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.
Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.
The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.
Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.
The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).
Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.
Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.
The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.
Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.
The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).
Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.
Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.
The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.
Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.
A version of this article first appeared on Medscape.com.
Starting April 5, patients can read your notes: 5 things to consider
Change in writing style is not mandated
The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.
Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”
This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.
Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
Clinicians don’t have to change writing style.
The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.
“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.
Everyday experience should guide clinicians when writing notes, said one expert.
“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.
According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”
Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.
However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
Some clinical notes can be withheld.
The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.
There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.
The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
Some patients are more likely readers.
Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.
“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.
A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.
Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
You are part of the avant garde.
The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.
“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.
In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.
It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
The start day will come, and you may not notice.
“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.
“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.
Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.
However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”
Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.
The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Change in writing style is not mandated
Change in writing style is not mandated
The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.
Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”
This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.
Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
Clinicians don’t have to change writing style.
The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.
“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.
Everyday experience should guide clinicians when writing notes, said one expert.
“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.
According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”
Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.
However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
Some clinical notes can be withheld.
The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.
There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.
The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
Some patients are more likely readers.
Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.
“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.
A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.
Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
You are part of the avant garde.
The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.
“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.
In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.
It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
The start day will come, and you may not notice.
“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.
“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.
Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.
However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”
Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.
The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.
Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”
This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.
Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
Clinicians don’t have to change writing style.
The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.
“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.
Everyday experience should guide clinicians when writing notes, said one expert.
“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.
According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”
Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.
However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
Some clinical notes can be withheld.
The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.
There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.
The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
Some patients are more likely readers.
Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.
“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.
A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.
Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
You are part of the avant garde.
The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.
“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.
In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.
It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
The start day will come, and you may not notice.
“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.
“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.
Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.
However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”
Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.
The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
History made, history revisited
The Biden administration has passed and signed the $1.9 trillion American Rescue Plan, which contains a plethora of moneys targeted to people, businesses, and health systems impacted by the pandemic. According to the Economist, the bill would bring the amount of COVID-related spending since December 2020 to $3 trillion (14% of prepandemic GDP) and to $6 trillion since the start of the pandemic. This type of stimulus (regarded as income, not savings, by most people) will generate unprecedented consumer spending. The risk, of course, is inflation, rising interest rates, and long-term debt.
That said, there is substantial funding targeting scientific research, vaccine distribution, public health entities, global health initiatives, rural health care, and a variety of other health-related issues. By my rough estimation, the Centers for Disease Control and Prevention will see $12 billion in incremental funding, $10 billion for public health projects including $3 billion for community health centers and federally qualified health centers, and over $3 billion for mental and behavioral health. The Department of Health & Human Services will see substantial funding for a variety of projects. Teaching health centers will see $330 million additional funds (including a $10,000 per-resident increase and payments to establish new graduate residency training programs).
The impact on low-income families and childhood poverty will be substantial and reverses the philosophical underpinning of recent welfare reforms. U.S. welfare dates back to the early 1900s and the philosophical foundation has evolved over time. According to the Constitutional Rights Foundation (www.crf-usa.org), it began after food riots broke out during the Great Depression. The Great Depression affected children and the elderly most severely, so the nation’s willingness to implement federal welfare was high. Prior to the Depression, the only federal program providing money to low-income people was the “mothers pension” designed to support poor fatherless children, but it excluded divorced, deserted and minority mothers. President Roosevelt was able to pass the Social Security Act (1935), which supported the elderly and began Federal welfare. During the Clinton presidency, welfare “as we know it” changed to include work requirements. With the passage of the current Biden legislation, those requirements are rolled back and funds are targeted broadly to low income Americans and children.
John I. Allen, MD, MBA, AGAF
Editor in Chief
The Biden administration has passed and signed the $1.9 trillion American Rescue Plan, which contains a plethora of moneys targeted to people, businesses, and health systems impacted by the pandemic. According to the Economist, the bill would bring the amount of COVID-related spending since December 2020 to $3 trillion (14% of prepandemic GDP) and to $6 trillion since the start of the pandemic. This type of stimulus (regarded as income, not savings, by most people) will generate unprecedented consumer spending. The risk, of course, is inflation, rising interest rates, and long-term debt.
That said, there is substantial funding targeting scientific research, vaccine distribution, public health entities, global health initiatives, rural health care, and a variety of other health-related issues. By my rough estimation, the Centers for Disease Control and Prevention will see $12 billion in incremental funding, $10 billion for public health projects including $3 billion for community health centers and federally qualified health centers, and over $3 billion for mental and behavioral health. The Department of Health & Human Services will see substantial funding for a variety of projects. Teaching health centers will see $330 million additional funds (including a $10,000 per-resident increase and payments to establish new graduate residency training programs).
The impact on low-income families and childhood poverty will be substantial and reverses the philosophical underpinning of recent welfare reforms. U.S. welfare dates back to the early 1900s and the philosophical foundation has evolved over time. According to the Constitutional Rights Foundation (www.crf-usa.org), it began after food riots broke out during the Great Depression. The Great Depression affected children and the elderly most severely, so the nation’s willingness to implement federal welfare was high. Prior to the Depression, the only federal program providing money to low-income people was the “mothers pension” designed to support poor fatherless children, but it excluded divorced, deserted and minority mothers. President Roosevelt was able to pass the Social Security Act (1935), which supported the elderly and began Federal welfare. During the Clinton presidency, welfare “as we know it” changed to include work requirements. With the passage of the current Biden legislation, those requirements are rolled back and funds are targeted broadly to low income Americans and children.
John I. Allen, MD, MBA, AGAF
Editor in Chief
The Biden administration has passed and signed the $1.9 trillion American Rescue Plan, which contains a plethora of moneys targeted to people, businesses, and health systems impacted by the pandemic. According to the Economist, the bill would bring the amount of COVID-related spending since December 2020 to $3 trillion (14% of prepandemic GDP) and to $6 trillion since the start of the pandemic. This type of stimulus (regarded as income, not savings, by most people) will generate unprecedented consumer spending. The risk, of course, is inflation, rising interest rates, and long-term debt.
That said, there is substantial funding targeting scientific research, vaccine distribution, public health entities, global health initiatives, rural health care, and a variety of other health-related issues. By my rough estimation, the Centers for Disease Control and Prevention will see $12 billion in incremental funding, $10 billion for public health projects including $3 billion for community health centers and federally qualified health centers, and over $3 billion for mental and behavioral health. The Department of Health & Human Services will see substantial funding for a variety of projects. Teaching health centers will see $330 million additional funds (including a $10,000 per-resident increase and payments to establish new graduate residency training programs).
The impact on low-income families and childhood poverty will be substantial and reverses the philosophical underpinning of recent welfare reforms. U.S. welfare dates back to the early 1900s and the philosophical foundation has evolved over time. According to the Constitutional Rights Foundation (www.crf-usa.org), it began after food riots broke out during the Great Depression. The Great Depression affected children and the elderly most severely, so the nation’s willingness to implement federal welfare was high. Prior to the Depression, the only federal program providing money to low-income people was the “mothers pension” designed to support poor fatherless children, but it excluded divorced, deserted and minority mothers. President Roosevelt was able to pass the Social Security Act (1935), which supported the elderly and began Federal welfare. During the Clinton presidency, welfare “as we know it” changed to include work requirements. With the passage of the current Biden legislation, those requirements are rolled back and funds are targeted broadly to low income Americans and children.
John I. Allen, MD, MBA, AGAF
Editor in Chief