HHPR Fall 2014 Issue

HHPR Harvard Health Policy Review

Iatrogenesis Addressing the fallout when healing harms

Volume 14 Issue 1

HARVARD HEALTH POLICY REVIEW VOL. 14, ISSUE 1 WWW.HHPRONLINE.ORG

Editor’s Note

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Muhammad Sarib Hussain

FEATURES Iatrogenic Harm in Primary Care

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Aziz Sheikh, MBBS, MD, MSc and David W. Bates, MD, MSc

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Eli Y. Adashi, MD, MS

Iatrogenic Birth Plurality: The Challenge and Its Possible Solution

Digital Iatrogenesis: Policy Advocacy to 11 Tim K. Mackey, MAS, PhD and Bryan A. Liang, MD, JD, PhD Prevent Patient Harm from Access to Dangerous Drugs Online HEALTH HIGHLIGHTS Iatrogenesis and Causality in 14 Gerald Young, PhD, and Jenny X. Wang Psychological Injury and Law: Concepts and Recommendations Innovating to End Death and Disability 17 Thomas F. Burke, MD and Roy Ahn, MPH, ScD of Our World’s Mothers STUDENT CONTRIBUTIONS The Impact of the Greek Financial Crisis: 20 Elise Baranouski The Neoliberal Response and Resulting Public Health Challenges Targeting National Emergency 23 Christina A. Nguyen, Jenny A. Shih, Katerina V. Lin, Oludamilola A. Aladesanmi Department Overuse: A Case for Primary Care, Financial Incentives, and Community Awareness

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editor’ s note At its core, medical care is a balancing act—a gestalt in which each move carries with it the danger of untoward consequences. Providers must constantly balance the possibility of benefit against the cost of treatment. In an age where treatments are becoming ever more sophisticated and provider interventions ever more routine, the possibility of harming the patient while healing her is increasing by leaps and bounds. Indeed, if iatrogenesis were to be defined as the morbidity associated with treatment, provider induced harm can accompany virtually every step of medical treatment. For a profession whose cardinal promise is to do no harm, iatrogenesis quickly raises germane issues of ethics that the medical community as a whole has yet to grapple with satisfactorily. Taken together, the issues surrounding iatrogenesis make for a fascinating inquiry and it is to this inquiry that we at HHPR have dedicated our Fall 2014 issue.

Editor-in-Chief Muhammad Sarib Hussain Managing Editor Eunah Lee Business Manager D.J. Brooks Design Chairs Melinda Song Sandy Wong Publishing Chair Kamran Jamil Senior Editors Bridgette Slater, features Grace Xiao, health highlights Edna Wang, student contributions Young Mi Kwon, online content Associate Editors Eric Li, business Fatma Akcay, design Huey Shih, design Natalie Cho, publishing Lauren Claus, features Risham Dhillon, health highlights Megan Gao, student contributions Anthony Thai, student contributions Chelsea Wang, online content Patric Cao, online content

The Harvard Health Policy Review is an undergraduate publication of Harvard College. The Harvard name and Veritas Shield are trademarks of the President and Fellows of Harvard University.

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No part of this publication may be reproduced in any form without express written consent from the publisher.

In this issue we have tried to curate a truly unique combination of pieces relating to iatrogenic harm that captures the diversity of the subject. Our Features section opens with an article by Dr. Sheikh and Dr. Bates, chairs of the WHO’s ‘Primary Care for All’ Working Group, wherein they discuss the necessity of grappling with iatrogenic implications of the increasingly popular, primary carecentered model of health care delivery. This is followed by an article by Dr. Adashi, Professor of Medical Science at the Warren Alpert School of Medicine at Brown University, which expounds on the phenomenon of iatrogenic birth plurality-an unforeseen yet very tangible consequence of the advances of reproductive IVF technologies. Dr. Mackey, Director of Global Health Policy Institute, and Dr. Liang, Director of Patient Safety at the UCSD School of Medicine close our Features section with a fascinating discussion about the risk of online pharmacies and the challenge they present to the traditional understanding of iatrogenesis.

Building on this theme, Dr. Young’s piece opens our Health Highlights section providing a detailed account of iatrogenesis in the realm of psychology and its interactions with the law. Dr. Burke, Assistant Professor of Surgery at Harvard Medical School and Dr. Ahn, Instructor in Surgery at Harvard Medical School, close out Health Highlights with a discussion on maternal mortality in resource-poor settings.

Finally, our Student Contributions section closes out the publication by offering students a platform to participate in the discourse on health policy. Our pieces for this issue focus on public health challenges resulting from the Greek financial crisis and the phenomenon of emergency department overuse across the country.

For their unwavering commitment and efforts in developing this issue, we’d like to thank our managing editor and the rest of our dedicated staff on our editorial review, design, technology, publishing and business boards. We would also like to thank our advisers Warner Slack, MD, David Cutler, PhD, Mary-Jo Good DelVechhio, PhD, and Peter Grant, JD for making themselves available to guide us through the publication process.

We also would like to take a moment to thank our readership for their patience during the new academic year as we implement a restructuring plan for the publication and lay its foundations anew.

Finally we would encourage our readers to explore our website at www.hhpronline.org for more information about the publication, subscription information, and updates about upcoming events.

To supplement our print publication, we would also encourage readers to read our new online blog called HHPRTalk, which is accessible from our homepage. As always, any questions or comments from our readers are warmly welcomed and can be addressed to hhpr.harvard@gmail.com.

We hope you enjoy this latest issue of HHPR, and we would like to thank you for your readership.

Sincerely, Muhammad Sarib Hussain Editor-in-Chief 2014-15

about the cover Photo illustration by Melinda Song.

Modified from stock image via Wikimedia Commons, Creative Commons Attribution.

acknowledgements The Harvard Health Policy Review would like to thank the Harvard Undergraduate Council and The Institute of Politics at Harvard University for their generous support of this publication.

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FEATURES

Iatrogenic harm in primary care

By Aziz Sheikh, MBBS, MD, MSc and David W. Bates MD, MSc

Fueled by the need for governments to develop more accessible, coordinated, efficient, and sustainable models of health care provision, there has been widespread policy agreement on the need to move to primary care-based models of care. As much as this is welcome, this transition needs to be managed in a way so as to minimize the risks of iatrogenic harm and to take the opportunity to embed patient safety considerations firmly within health systems. In this article, we discuss why focusing on safety in primary care contexts is of critical importance, reflect on the key challenges in developing a secure evidence base, summarize progress that has been achieved in understanding the contexts in which iatrogenic harm is most likely to arise, and highlight approaches to reducing the risks of iatrogenic harm in primary care settings globally. We end by identifying key research opportunities in this expanding field of inquiry.

Publication of the seminal Harvard Medical Practice Studies, and the subsequent Institute of Medicine report “To Err is Human,” catalyzed international interest in the risk of iatrogenic harm, though these focused largely on harm in hospitalized patients. Academic and policy efforts have, in this setting, gradually shifted from an initial focus on describing the frequency and outcomes of iatrogenic harm to understanding the causes underpinning these errors and, most recently, to developing and testing interventions to enhance the safety of hospital care provision.

In comparison, however, there has been relatively little effort devoted to describing, understanding, and taking steps to reduce the risk of iatrogenic harm in primary care settings, even though patients spend the vast majority of their time outside the hospital, and the trend is to treat many illnesses that would previously required hospitalization in the outpatient setting. Following the World Health Organization’s (WHO) recommitment to universal health coverage and, in particular, primary care provision, this picture is beginning to change. From our vantage point as chairs of the recently established WHO Safer Primary Care for All Expert Working Group, we seek in this paper to provide a high-level overview of the current understanding of the burden of iatrogenic harm in primary care settings, identify the contexts and types of errors that are particularly liable to result in major iatrogenic harm, and identify key priorities for future research. We begin by discussing some of the reasons for focusing attention on the issue of iatrogenic harm in primary care and by considering some of the challenges that need to be overcome in order to make progress with this agenda.

than in-patient hospital care.

• Health in populations is strongly associated with access to primary care and less so with specialty care.

• Although associated with substantial health benefits when indicated, hospital care can also prove very dangerous with estimates indicating that at least 10% of hospitalized patients may be harmed in the process of receiving care in developed countries, where this figure is likely higher for developing and transitional countries.

The experience from nations (for example, the United Kingdom) that have already largely made this transition to a primary care-led service indicate that it is possible for over 90% of all patient interactions with health care providers to take place within primary care. Similar developments are taking place throughout the economically-developed world – for example, the role of primary care in the United States is expected to be strengthened by the move to expand health coverage through the Affordable Care Act and the drive towards more accessible and value-based care, which is being catalyzed through the development of the Accountable Care Organizations and Patient Centered Medical Homes. Although often proceeding at a slower pace, related developments are also taking place in many low- and middle-income country settings. Given this reality, it is imperative that there is a comprehensive appreciation of the risks of iatrogenic harm in primary care settings so that the expansion of primary care provision progresses in as safe a manner as possible.

The challenges of studying iatrogenic harm in primary care settings There are a number of major challenges to progressing understanding of iatrogenic harm in primary care settings. Perhaps foremost amongst these is the belief held by some that primary care is of lesser importance than hospital settings because primary care-based practitioners tend to deal with lower risk, less complex patients than those managed in hospital in-patient settings; closely related to this is the belief that primary care practitioners undertake procedures and initiate treatments that are inherently less risky than those delivered by their internist and specialist colleagues. This has led to the relatively neglected nature of safety considerations in primary care by policymakers and academics alike. Whilst these judgments may be true in some or indeed many cases, it is important to recognize that as more and more patients are shifted from hospital to community settings, primary care providers are now routinely seeing a much more complex array of patients – frequently with multi-morbidity – than would have been the case even a generation ago. Furthermore, even if the relative risk of harm to individuals associated with for example a particular treatment is low; given the very high volume of patients seen and managed in primary care settings, the absolute risk of iatrogenic harm in primary care is likely to be very substantial.

Rationale for focusing on primary care There is a global transition taking place to primary care-based models of care, this being motivated by a number of factors, including the recognition that: • Patients – particularly those with long-term conditions – greatly value continuity of care • Patients prefer to be treated close to home, in their local communities.

• It is now possible to deliver many of the The experience from nations ... that have already largely made diagnostic tests and interventions that this transition to a primary care-led service indicate that it is were previously the exclusive preserve of possible for over 90% of all patient interactions with health specialists in primary care settings.

• Primary care is typically less expensive care providers to take place within primary care.

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Whilst the above argument has largely been won, there remains the challenging reality that primary care encompasses a diverse array of providers (e.g. physicians, nurses, physician assistants, dentists, community midwives, etc) delivering care across a broad range of settings (from community clinics to hospital out-patient clinics to emergency rooms), where all of this is distributed in both time and space.

This presents evaluators with serious issues.

The models of primary care provision also vary by country and sometimes even within countries by health system ranging from, for example, fee-for-service to individual insurance to national insurance-based financing arrangements. There is therefore considerable heterogeneity not only in the patient mix, but also in provider and health system related considerations, which can make it difficult to generate comparable data and generate reliable estimates of the burden of iatrogenic harm.

Other important considerations include a lack of international agreement on terminology, definitions of key concepts and a taxonomy for classifying errors or harm, and the inherent limitations of using chart review-based methods which have so successfully been used in hospitalized patients when these at best only provide a snapshot of key clinical decisions and outcomes of primary care provision.

Finally, it is also important to note that not all iatrogenic harm is the result of error. This is because iatrogenic harm can also result from known and carefully considered risk of side effects (e.g. dyspepsia in those taking non-steroidal anti-inflammatory drugs for rheumatoid arthritis who experience adverse effects despite appropriate preventive and prophylactic measures), provider negligence and – in a very small minority of cases – due to frank criminality (e.g. the case of the British general practitioner Dr. Harold Shipman who murdered at least 250 of his patients). The policy responses needed in relation to negligence and/or deliberate provider harm are quite distinct from that needed for the more common problem of iatrogenic harm resulting from the medical errors inadvertently made by wellintentioned health care providers, which has been the focus of our work.

Error-related iatrogenic harm in primary care The scale of the problem Given the above caveats, it has been difficult to generate reliable estimates of the

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Members of the WHO Safer Primary Care Expert Working Group Photo courtesy of author frequency of errors in primary care or indeed the associated burden of iatrogenic harm.

That said, our work undertaken on behalf of the WHO suggests that errors occur in 2-3% of primary care-based encounters in highincome countries and that a proportion of these errors translate into actual patient harm.

The data do however indicate that these risks can vary very considerably by setting, error type and patient characteristics.10 It is also likely that the net magnitude of the problem is considerable, especially for some areas such as medication safety in developed countries, which use large numbers of medications compared to the amounts used by developing and transitional countries.

The frequency of errors and burden of harm in the ambulatory setting is largely unknown in economically-developing regions of the world.

Setting and provider related considerations A number of important underlying structural and professional issues can impact on the frequency with which errors occur and the opportunity to detect, resolve and learn from these in order to minimize the risk of actual harm. These include the adequacy of premises and equipment, appropriate levels of staffing and skill mix, agreed pathways and protocols for care and standards of clinical documentation, and adequate training and support for frontline providers. Shortcomings in these areas may lead to serial systems failures with the consequent increased risk of errors and patient harm. In contrast, providers who

proactively seek to detect errors, reflect on these when they occur in an open manner with other stakeholders – including patients and family members – and who then take actions to prevent recurrences have the hallmarks of a learning organization.

Error type Diagnostic and medication-related errors are most likely to result in actual patient harm. Examples of the former include a missed diagnosis of meningitis or a delayed diagnosis of cancer; examples of the latter center on errors relating to the prescribing and/or monitoring of medication. Failure to respond to laboratory or radiological findings such as elevated cancer markers or new lung nodules represent important opportunities to improve safety. When malpractice claims are reviewed, communication issues are frequently identified as issues, and failure to diagnose or the delayed diagnosis of cancer is especially important. Medication-related harm often relates to dosage errors, failure to monitor, known allergies, and drug-drug interactions that might have been avoided.

Although administrative errors are common, these less frequently result in clinically important harm.

Patients at greatest risk There are a number of patient-related factors which may increase the risk of iatrogenic harm, including: patient age (the very young and old); the physiologically compromised; those with complex underlying disease and/or multi-morbidity; those with behavioral health issues, those

on multiple treatments; and patients with language, communication and/or psychosocial difficulties.

Approaches to enhancing the safety profile of primary care provision Although this area of work is still very much in its infancy, we wish to draw attention to both generic and more specific interventions that have the potential to prove effective.

Generic approaches to strengthening health systems There are a number of approaches that can be taken to enhance the safety of health systems, many of which are often taken for granted in high-income country settings.12 These include ensuring that health professionals are adequately trained, formally assessed as being competent, regularly engage in continuing professional development, and are periodically reassessed as being fit to practice through revalidation processes. There are also gains to be had through regulation of medicinal products, medical devices and procedures, developing mechanisms to report adverse events (to the Food and Drug Administration and its equivalent in other parts of the world), and through creating local, state or federal repositories of errors and associated patient harm. The above list is by no means exhaustive, but should help illustrate the range of structural considerations that can help to strengthen the safety of health systems.

More specific interventions In addition to the above generic approaches, there is a need to focus on the contexts, error types and patient groups at greatest risk of iatrogenic injury. The most progress in this respect has been made in relation to medication errors in ambulatory or general practice settings, where this work has demonstrated that electronic health records and associated computerized decision support functionality can reduce the risk of medication errors. Research has also shown that interrogation of electronic health record data for known indicators of suboptimal prescribing practices and the introduction of a pharmacist into the primary care team can also substantially reduce the risk of important prescribing and medication monitoring errors.

Tools to improve follow-up of important clinical test results can also decrease risk. These are more effective for clinical laboratory tests, which have clear levels of normal and abnormal, and harder to implement for radiological procedures,

Even when errors are reduced, establishing whether patient outcomes are actually improved has been somewhat elusive. which typically have unstructured results.

However, tools to ensure that key radiological abnormalities receive appropriate follow-up have been highly effective.

In developing countries, issues such as safe injection practices are very important, as are approaches to ensure that medications are not counterfeit.

There has been comparatively less progress in identifying approaches to reducing the risk of diagnostic errors, this in part reflecting the fact that diagnosis is a highly complex process that relies on a combination of knowledge, experience, and an intuitive ‘sixth sense’. The opportunities for better remote monitoring of physiological and other parameters through consumer health informatics devices, real-time specialist support using three-way video consults, trigger tools, and machine learning-based techniques that are increasingly becoming available do, however, provide some hope that progress can be made in reducing the risk of clinically important diagnostic errors.

Research gaps and priorities As will be obvious from the above discussion, we are still focused on trying to understand the magnitude of the problem in primary care and on identifying cost-effective and optimal approaches to reducing errors.

Even when errors are reduced, establishing whether patient outcomes are actually improved has been somewhat elusive this reflecting the relatively small-scale nature of many of the trials that have been undertaken and this being compounded by short follow-up periods of these interventions.

It is particularly important to underscore the need for safety related research in lowand middle-income country settings as the evidence base in relation to primary care is in these parts of the world largely non-existent.

Conclusions As primary care-based models of care continue to develop and spread, it is important that safety considerations are centrally embedded in these so as to ensure that the care is not only convenient, effective,

Photo from Wikimedia Commons Hand cleaning station at the entrance of Toronto General Hospital.

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and efficient, but also as safe as possible. This the most promising strategies for reducing field has historically been neglected when the risk of errors and iatrogenic harm. compared to hospital-based care, but this Diagnostic errors are another important picture is now beginning to change as a result source of avoidable morbidity and mortality of policymakers growing in primary care, and although appreciation of the centrality Support for this very limited progress has thus of primary care provision in far been made in reducing the creating sustainable health research, both risk of these outcomes there systems. Key issues that to describe the are a number of developments now need to be unraveled place which may help epidemiology taking include: obtaining an to reduce the risk of clinically accurate assessment of of the problem important diagnostic errors. the frequency of errors and to test The WHO will shortly be in different primary care issuing a WHO Global settings and patient groups, a interventions, is Roadmap for Safer Primary better appreciation of which greatly needed. Care, which will we hope to types of errors are most catalyze international interest likely to result in major iatrogenic harm, and in this increasingly important area of health equipped with these insights intervention policy and practice. studies investigating how best to enhance the safety of care provision. Support for this Acknowledgments: AS is supported research, both to describe the epidemiology by The Commonwealth Fund, a private of the problem and to test interventions, is independent foundation based in New York greatly needed. Prescribing and medication City. The views presented here are those of monitoring related errors are the fields in the author and not necessarily those of The which the most progress has been made. Commonwealth Fund, its directors, officers, This work has shown that electronic health or staff. Both authors acknowledge the records, computerized decision support, support of colleagues in the WHO Safer personal health records, academic detailing, Primary Care for All Expert Working Group. and pharmacist skill-mix interventions are

Aziz Sheikh, MBBS, MD, MSc is Professor of Primary Care Research & Development and Co-Director of the Centre of Population Health Sciences at The University of Edinburgh, Harkness Fellow in Health Care Policy and Practice at Brigham and Women’s Hospital, and Visiting Professor of Medicine at Harvard Medical School.

1. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients.

Results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324(6): 370-6.

2. Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, Hebert L, Newhouse JP, Weiler PC, Hiatt H. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324(6): 377-84.

3. Kohn LT, Corrigan JM, Donaldson MS, Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000.

4. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press, 2001.

5. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009; 360(5): 491-9.

6. Wilson T, Pringle M, Sheikh A. Promoting patient safety in primary care. BMJ 2001; 323: 583-4.

7. WHO. The world health report 2008—primary health care (now more than ever). World Health Organization, 2008. http://www.who. int/whr/2008/en/ (accessed May 5, 2014).

8. Patient Protection and Affordable Care Act. Available from: http://www.hhs.gov/healthcare/rights/law/index.html (accessed May 5,

reduce medication related adverse events and hospital admissions: systematic review and meta-analysis. Qual Saf Health Care 2006; 15(1): 23-31.

19. Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Cresswell K, Eden M, Elliott RA, Howard R, Kendrick D, Morris CJ, Prescott RJ, Swanwick G, Franklin M, Putman K, Boyd M, Sheikh A. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012; 379(9823): 1310-9.

20. Avery AJ, Rodgers S, Franklin BD, Elliott RA, Howard R, Slight SP, Swanwick G, Knox R, Gookey G, Barber N, Sheikh A. Research into practice: safe prescribing. Br J Gen Pract 2014; 64(622): 259-61.

21. Matheny ME, Sequist TD, Seger AC, Fiskio JM, Sperling M, Bugbee D, Bates DW, Gandhi TK. A randomized trial of electronic clinical reminders to improve medication laboratory monitoring. J Am Med Inform Assoc 2008; 15(4): 424-9.

22. Schiff GD. Diagnosis and diagnostic errors: time for a new paradigm. BMJ Qual Saf 2014; 23(1): 1-3.

23. Zwaan L, Schiff GD, Singh H. Advancing the research agenda for diagnostic error reduction.

BMJ Qual Saf. 2013; 22 Suppl 2: ii52-ii57.

24. Cresswell KM1, Panesar SS, Salvilla SA, Carson-Stevens A, Larizgoitia I, Donaldson LJ, Bates D, Sheikh A; World Health Organization’s (WHO) Safer Primary Care Expert Working Group. Global research priorities to better understand the burden of iatrogenic harm in primary care: an international delphi exercise. PLoS Med 2013; 10(11): e1001554.

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2014).

9. Sheikh A, Panesar SS, Larizgoitia I, Bates DW, Donaldson LJ. Safer primary care for all: a global imperative. Lancet Global Health 2013; 1(4); e182-3.

10. WHO. Safer primary care. http://www.who. int/patientsafety/safer_primary_care/en/index.html (accessed May 5, 2014).

11. Hurwtiz B, Sheikh A (eds.). Health Care Errors and Patient Safety. Oxford: Wiley Blackwell, 2001.

12. Reason J. Human Error. New York: Cambridge University Press; 1990.

13. Wilson T, Sheikh A. Enhancing public safety in primary care. BMJ 2002; 324: 584-7.

14. Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. Adverse drug events in ambulatory care. N Engl J Med 2003; 348(16): 1556-64.

15. Schiff GD, Puopolo AL, Huben-Kearney A, Yu W, Keohane C, McDonough P, Ellis BR, Bates DW, Biondolillo M. Primary care closed claims experience of Massachusetts malpractice insurers. JAMA Intern Med 2013; 173(22): 2063-8.

16. Panesar SS, Cleary K, Sheikh A. Reflections on the National Patient Safety Agency’s database of medical errors. J R Soc Med 2000; 102(7): 256-8.

17. Schedlbauer A1, Prasad V, Mulvaney C, Phansalkar S, Stanton W, Bates DW, Avery AJ. What evidence supports the use of computerized alerts and prompts to improve clinicians’ prescribing behavior? J Am Med Inform Assoc 2009; 16(4): 531-8.

18. Royal S, Smeaton L, Avery AJ, Hurwitz B, Sheikh A. Interventions in primary care to

David W. Bates, MD, MSc is Senior Vice President for Quality and Safety and Chief Quality Officer at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and Professor in the Department of Health Policy and Management at Harvard School of Public Health.

FEATURES

IVF birth cohort, respectively. In that the number of IVF births are inextricably linked to the number of embryos transferred, and the national embryo transfer trends were monitored from 1997 through 2011, the last year for which reliable data were available.8 All told, the national fraction of three or rate in the US, note was made of an overall more embryo transfers decreased from 83 1.9-fold increase from 1967 through 2012.8 to 24%, the national fraction of two embryo Characterized by limited growth between transfers increased from 12 to 55%, and the 1967 and 1980, the national twin birth rate national fraction of single embryo transfer grew by 2.2% per year through 2004 only increased from 5 to 21%. Taken together, to plateau thereafter. Importantly, however, these observations reveal progressive the national twin birth rate has yet to reverse improvements in the practice pattern of IVF course. A comparable analysis of the national and in its diminishing contribution to the higher-order (triplets and beyond) birth rate national multiple births excess. revealed a 6.7-fold increase to a 1998 high.8 With an eye towards analyzing the role of Since that time, note was made of a 36% non-IVF technologies in the national multiple decrease through 2012. Taken together, these birth excess, their relative contribution to the observations indicate that national twin and higher-order the dimensions of the The dimensions of birth rates was analyzed from multiple births epidemic through 2011, the last the multiple births 1997 remain substantial. In year for which reliable data remain were available.8 Surprisingly, turn, the directionality epidemic of the multiple births substantial. the relative contribution of epidemic suggests that it non-IVF technologies to the may have crested in that the national twin national twin birth rate consistently exceeded birth rate has in effect plateaued and in that that of its IVF counterpart throughout the national higher-order birth rate has been the period in question. Much of the same receding. was apparent since 2004 for the relative To assess the role of IVF in the national contribution of non-IVF technologies to multiple births epidemic, the IVF birth order the national higher-order birth rate. Taken rates were monitored from 1997 through together, these observations reveal that IVF 2011, the last year for which reliable data does not fully account for the iatrogenically were available.8 In aggregate, the national derived multiple infants in the US. Indeed, IVF higher-order birth rate declined by since 1997, IVF was not the leading 78%, the national IVF singleton birth rate contributor of twins and since 2004, IVF increased by 26%, and the national IVF twin was not the leading contributor of higherbirth rate remained unchanged. By 2011, order infants. It follows that going forward, singletons, twins, and higher-order births greater attention would have to be paid to constituted 54, 43, and 3% of the national the impact of non-IVF technologies.

Iatrogenic Birth Plurality: The Challenge and Its Possible Solution

By Eli Y. Adashi1, MD, MS The actualization of In-Vitro Fertilization (IVF) as a therapeutic modality constituted a disruptive innovation.1 As such, IVF, recognized by a Nobel Prize in Physiology and Medicine, vanquished barrenness and changed infertility care as we knew it.2 What is more, IVF spawned a host of technical, and indeed improbable breakthroughs, none of which could have been foreseen.

Concurrently however, IVF brought about an unintended consequence—that is—an excess of multiple births.3 In so doing IVF was hardly alone. Other (non-IVF) fertilitypromoting technologies have also done their part.4 In this communication we describe the dimensions of the US multiple births excess, delineate its directionality, and define the drivers thereof.

The FDA approval of the drug Clomiphene Citrate in 1967 constitutes the proximate bookend of the modern fertilitypromoting era.5 Indeed, Clomiphene Citrate proved to be the first ever agent to bring about ovulation in women who are otherwise anovulatory. It follows that all multiple births in the US prior to 1967 were by definition spontaneous. Stated differently, 1967 marks the onset of the US multiple births epidemic.

Other notable milestones include 1981, which marks the onset of the IVF paradigm in the US, and the introduction of medicated Intrauterine Insemination (IUI) in 1987 as a prelude to IVF.6,7 In monitoring the national twin birth 1

Professor of Medical Science, Warren Alpert Medical School, Brown University,

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Altering the impact of non-IVF technologies such as medicated IUI could entail one of the following policy choices: modified, minimized, or altogether discontinued use. The modified use approach is readily at hand. All that is required is the implementation of more prudent practice patterns as defined by professional associations.9 The case for minimized use appears particularly strong.

Indeed, as a carefully carried out study demonstrated, the elimination of medicated IUI as a prelude to IVF is associated with

fact state preference for a plural birth though true appreciation of the risks involved may well be variable.

Regrettably, the state of underwriting of infertility care in the US is not likely to improve any time soon. A national (single payer) health insurance plan is unlikely to take hold in our lifetime. Even if it were, it is unlikely that such a plan will underwrite infertility care given the pro-choice-pro-life divide. At best, infertility care might be the subject of federal tax credits courtesy of The Family Act bill if and when it is enacted.

At best, infertility care might be the subject of federal tax credits courtesy of The Family Act bill if and when it is enacted. a shorter time-to-pregnancy, a higher pregnancy rate, lower cumulative costs per delivered child, and comparable plurality rates.10 The case for minimized use appears to be further buttressed by the growing realization that medicated IUI may not be cost-saving to payers. It is thus likely that payers will increasingly discourage the use of medicated IUI. Instead, payers will likely be promoting a direct path to IVF. Although discontinued use of medicated IUI could be considered as a risk-reducing strategy, such may be premature. Moreover, compassionate consideration may require that medicated IUI be reserved for those patients who cannot afford the high costs of IVF. At first blush, eliminating the contribution of IVF to the multiple birth epidemic may appear simple. After all, limiting transfers to a single embryo is all that it would take.

However, this idealized approach runs up against the realities of underwriting infertility care in the US wherein most couples are either under- or uninsured.

Whatever underwriting of infertility therapy there currently is, it is exclusively private, largely self-funded, partially state-mandated, and at times employer-sponsored. Against this backdrop, it is not unusual for patients to take a dim view of the single embryo transfer option. Paraphrased sentiments may include but need not be limited to: “One embryo may not be enough to assure conception; Double embryo transfer makes more sense in the face of the high upfront costs involved not to mention the fact that the costs of plural births will be covered.” Above and beyond these considerations, some patients do in

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It follows that the American solution to the IVF challenge will require ongoing education of patients, providers, payers, and policymakers. At the same time, every effort will have to be made to allow technology to optimize embryo selection and implantation.

It is then, and only then, that one can finally expect increasing acceptance of single embryo transfers and the likely attendant risk reduction of birth plurality. In a word, the way forward will be stepwise and timeconsuming.

Not surprisingly, the resolution of the US multiple birth epidemic will not be as simple

1. Steptoe P.C., Edwards R.G. Birth after the reimplantation of a human embryo. Lancet 1978 2:366.

2. Nobelprize.org. The Nobel Assembly at Karolinska Institutet. The Nobel Prize in Physiology or Medicine 2010. Robert G. Edwards. October 4, 2010. http://www. nobelprize.org/nobel_prizes/medicine/ laureates/2010/press.html.

3. Adashi EY, Barri PN, Berkowitz R et al.

Infertility therapy-associated multiple pregnancies (births): an ongoing epidemic.

Reprod Biomed Online. 2003 7(5):515-42.

4. McClamrock HD, Jones HW, Adashi EY. Ovarian Stimulation and Intrauterine Insemination at the Quarter Centennial: Implications for the Multiple Births Epidemic.

Fertil Steril 2012 97(4):802-809.

5. Nasseri S, Ledger WL. Clomiphene citrate in the twenty-first century. Hum Fertil (Camb).

2001 4(3):145-51.

6. Jones HW Jr, Jones GS, Andrews MC, Acosta A, Bundren C, Garcia J, Sandow B, Veeck L, Wilkes C, Witmyer J, Wortham JE, Wright G. The program for in vitro fertilization at Norfolk. Fertil Steril 1982 38(1):14-21.

as one, two, three. It would have been had we as a nation elected to underwrite infertility benefits. Indeed, the very solution of the American challenge is inextricably linked to how we as a nation see the right to health, how we view health as a business, how we view infertility as a condition, and how we reconcile our pro-choice or pro-life beliefs.

Still, through ongoing education and through the harnessing of technology, progress will be made. One cannot afford not to. In the words of Mark Twain: “Sufficient unto the day is one baby. As long as you are in your right mind don’t you ever pray for twins.

Twins amount to a permanent riot; and there ain’t any real difference between triplets and an insurrection.”11

Eli Y. Adashi, MD, MS, CPE, FACOG is Professor of Medical Science and the former Dean of Medicine and Biological Sciences at Brown University.

Har vard-educated in Health Care Management, Dr. Adashi is a member of the Institute of Medicine of the National Academy of Sciences, the Association of American Physicians, and the American Association for the Advancement of Science.

7. Dodson WC, Whitesides DB, Hughes CL Jr, Easley HA 3rd, Haney AF. Superovulation with intrauterine insemination in the treatment of infertility: a possible alternative to gamete intrafallopian transfer and in vitro fertilization.

Fertil Steril 1987 48(3):441-5.

8. Kulkarni AD, Jamieson, DJ, Jones HW Jr, Kissin, DM, Gallo, MF, Macaluso, M, Adashi EY. Fertility Treatments and Multiple Births in the United States. New Engl J Med 2013 369(23):2218-25.

9. Practice Committee of American Society for Reproductive Medicine. Multiple gestation associated with infertility therapy: an American Society for Reproductive Medicine Practice Committee opinion. Fertil Steril 2012 97(4):825-34.

10. Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL, Alper MM, Goldman MB. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertil Steril 2010 94(3):888-99.

11. Twain M. Speech On The Babies. http://www. online-literature.com/donne/3274/.

FEATURES

Digital Iatrogenesis: Policy Advocacy to Prevent Patient Harm from Access to Dangerous Drugs Online

By Tim K. Mackey, MAS, PhD,*&¶§ and Bryan A. Liang, MD, JD, PhD *¶§ Iatrogenesis is an old concept that has broadened in scope and depth since Ivan Illich’s book Medical Nemesis sparked new debate about the need to recognize differences between clinical, social and cultural iatrogenesis types in the 1970s.

Yet, in today’s increasingly digitized world, there may be need for further modernization of iatrogenesis to reflect growing potential for patient harm from the Internet and related technologies. This specifically includes the patient safety and public health risks emanating from illicit online pharmacies, many of which sell questionable and counterfeit drugs directly to the patient. This piece outlines these risks, including summarized findings from studies showing that clearly dangerous drugs are available online. It also suggests a modernizing of iatrogenesis to include the new concept of “digital iatrogenesis” in order to raise awareness and address a constantly changing online health environment.

Iatrogenesis, or the “iatrogenic effect,” is traditionally defined as preventable harm resulting from medical treatment or advice to a patient delivered by a health care professional.

This is an ancient concept that has been recognized for centuries as early as the time of Hippocrates.1 Effectively addressing underlining causes of iatrogenesis is a key component of the patient safety movement made prominent in the groundbreaking 1999 Institute of Medicine report “To Err is Human.”2,3 Specifically, iatrogenesis can include adverse drug events caused by drug interactions, allergic reactions, and even treatment failure due to growing antibiotic drug resistance.4,5 In addition, the concept of medical iatrogenesis has broadened in its scope beyond the clinical setting, and includes

definitions of social iatrogenesis (generally understood as medicalization of life and aspects of clinical practice and medical industries that lead to excessive dependence on medical care) and cultural iatrogenesis (when medicalization leads to cultural harm due to loss of traditional ways in dealing with disease and illness).6,7 Drug safety issues arising from forms of iatrogenesis continue to be a problem in our modern and increasingly health-driven society. This includes a national prescription drug abuse epidemic that continues to cause significant patient safety, social, and economic harms, the causes of which can often be traced to failures in appropriate clinical diagnosis and treatment, medicines prescribing, and controlling access to prescription drugs with abuse potential.8 Despite these recognized

patient safety and public health risks, drugrelated iatrogenesis may be expanding far beyond these known risk areas into new and uncharted territories. This specifically includes the emergence of new and disruptive forms of digital technologies that now allow consumers the ability to source questionable health information and access healthcare services and products outside of the traditional healthcare setting.8,9 Though these digital technologies, such as the rapidly expanding “Health Internet” and social media, have the potential to enable consumer choices and awareness of health issues, unregulated and uncontrolled expansion has also led to clear online patient safety harms. In fact, of the 87% of U.S. adults that use the Internet, 72% of them looked for health information online for specific diseases or conditions, treatments or procedures, and for doctors or other health care professionals, yet the quality of the various sources of online health information is questionable.10,11 Hence, the concept of medical iatrogenesis may require modernization to include a new category of “digital iatrogenesis” that reflects the current realities of our social-media and online environment, particularly as it relates to safety of medicine’s access worldwide.

The Digital Global Counterfeit Drug Trade A relatively new phenomenon that has emerged from the evolution of the Internet and related technologies is the online pharmacy.

It is important to note that the fundamental concept of an “online” pharmacy is not in itself unique, as the growth of e-commerce has included virtually all aspects of the economy and participating industries, including health.

Yet, a key difference between the pharmacy

*Department of Anesthesiology, University of California, San Diego School of Medicine, San Diego, CA USA &Division of Global Public Health, University of California, San Diego School of Medicine, Department of Medicine, San Diego, CA USA ¶ San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA USA §Global Health Policy Institute, University of California, San Diego, San Diego, CA USA

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industry and other e-commerce platforms (e.g., consumer goods, travel sites, software, etc.) is that they function with the purpose of distributing regulated pharmaceuticals directly to consumers, a practice that requires authenticity/assurance of the product quality, licensure of the establishment, as well as appropriate dispensing authorized and overseen by a health professional (i.e., physician, pharmacist, etc.).12 Despite well-established legal and regulatory requirements needed to operate traditional brick and mortar pharmacies in virtually all jurisdictions, few countries have specifically regulated the online pharmacy industry.

13 Exacerbating the lack of targeted regulation are findings that the majority of online pharmacies do not adhere to existing pharmacy laws and regulations even when they apply in jurisdictions where they purport to operate.14 Indeed, illicit or “rogue” online pharmacies that operate in clear violation of applicable laws, are now a well-recognized public health and patient safety threat, and have been associated with patient injury, death, drug adverse events, and importantly have digitized the international criminal trade of counterfeit/spurious/falsified/ fraudulent medicines.9,12,15 The international community is starting to take notice, with the World Health Organization, Interpol, the UN Office of Drugs and Crime, the US Food and Drug Administration (FDA), the National Association of Boards of Pharmacy (NABP), and other organizations now actively warning consumers about the dangers of purchasing drugs online.9 Many of these rogue online pharmacies share similar characteristics and marketing tactics aimed directly at the consumer that are clear causes of iatrogenic conditions. These include “no prescription” online pharmacies that do not require a prescription from a consumer for drug purchase or may use other illegal methods to justify dispensing without a prescription (e.g., use of a dubious medical questionnaire or a providing a fraudulent prescription—for a price).12 Sites also often market versions of branded pharmaceutical products subject to patent or exclusivity protections as “generics,” even though a generic formulation is neither available nor authorized. Importantly, these sites focus on key aspects of medical consumerism potentially exacerbating social iatrogenesis effects, including encouraging consumers to seek drug treatment and offering ease of access and convenience to entice consumer purchasing without appropriate oversight or understanding.16

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The international community is starting to take notice... actively warning consumers about the dangers of purchasing drugs online.

Common iatrogenic effects can also result from consumers purchasing from illicit online pharmacies even if a product is authentic. This includes patients selfdiagnosing a medical condition and treating it incorrectly, negative drug interactions due to lack of clinical oversight, possible drug addiction from use of controlled substances, and lack of clinical monitoring and follow up to determine if treatment is effective.9,12 However, arguably, the greatest risk emanates from possible consumption of fraudulent or counterfeit product that can result in direct patient harm.12 These iatrogenesis-related risks are further amplified by the online presence of drugs that represent clear and arguably irrefutable patient safety risks.

Dangerous Drugs Online In the presence of certain clearly dangerous drugs online, appropriate regulation of online pharmacies to ensure equitable and safe access to medicines for populations that desperately need treatment points to the need for immediate policy attention. This need is reified as recent studies have found that key drugs have been subject to suspect sales, including vaccines, narrow therapeutic index drugs (“NTIs”), drugs subject to recall/ withdraw, and drugs that have not even received regulatory approval for sale being offered by online pharmacies.

For example, in the case of vaccines, a study in the journal Vaccine in 2012 found that all vaccines listed on FDA Biological Shortage list (including Hepatitis A&B vaccines, and Zoster vaccine) were available online.17 The search was then expanded to assessment of online availability of all vaccines listed on the WHO Essential Medicines List (EML), where a similar result was found with all EML vaccines observed as available from online pharmacies.17 Online availability of vaccines introduces some clear patient safety issues. To begin, even if product is authentic at the time of shipment, most biologics/vaccines require proper cold storage for shipment in order to ensure potency, a practice that may or not be practiced by online sellers. Further, once a product is delivered to an end-user consumer, that individual may not have the appropriate training or instructions to self-administer the vaccine, further bringing into question the

viability of these products when sourcing them online. In addition, several sellers observed in the study advertised their vaccines as “over-the-counter” (a clear form of fraudulent marketing) and were international in origin or NABP “not recommended”, further highlighting potentially safety risks.17 The NTI drug class is also an important illustration of the clear risks to patients from purchasing online. NTI drugs are those medicines that have a narrow proximity between therapeutic and toxic amounts and have been associated with higher risk of adverse events.18 These drugs require close professional oversight when administering which is clearly absent in online drug purchasing. Further, NTI drugs require precise manufacturing of the product and often rely on originator information to establish bioequivalence, a situation which makes attempted counterfeiting an even more dangerous proposition.18 Yet, despite NTI risks, a study in Clinical Therapeutics in 2013 found that 92% of “core” NTI drugs were available online without a prescription.18 This is extremely concerning, as patients may reasonably attempt to obtain currently used medication forms on which they are stable, potentially leading to online purchases of questionable product.

Even more disturbing Internet developments are of concern. For example, online patient safety issues arising from online pharmacies are the purported offering for sale of drugs that have yet to receive regulatory approval for sale. Such is the case for antiobesity drug Belviq® (Lorcaserin), which at the time of a 2013 study in the journal Obesity, had received FDA approval, but was not legally on the market as it awaited U.S. Drug Enforcement Agency scheduling as a controlled substance.19 Despite not being legally available on the market, the study found that Belviq was not only actively being marketed, it was being also marketed for sale as a “no prescription” drug by online vendors and in large kilogram quantities by businessto-business wholesalers (B2B).19 What exactly was being purported to be sold by these online vendors is unclear, but due to the product’s unapproved status, all sales would be illegal.19 Finally, another class that appears to be a clear patient safety risk are drugs subject to drug regulatory agency permanent recall or withdraw. Though research is still pending, unpublished studies currently in development by authors of this piece have identified that many drugs subject to global permanent recall (including drugs associated with adverse risk of cardiovascular events

such as Mellaril (Thioridazine) and Darvocet (Dextropropoxyphene)) are actively marketed for sale online by illicit online pharmacies, via social media, and by B2B wholesalers including Alibaba.com. Permanently recalled/ withdrawn drugs offer yet another example of a clear patient safety threat as these drugs are generally no longer available on the market (bringing into question their authenticity) and can introduce significant patient safety risks and direct and indirect harms.

Digital Iatrogenesis Collectively, research and law enforcement activities relating to online pharmacies and Internet drug sales provide compelling examples of why the constantly changing and evolving digital health landscape requires the attention of the policy community in the context of iatrogenesis and broader patient safety concerns. Similar to Ivan Illich’s broadening of medical/clinical iatrogenesis to include social and cultural concepts first in 1974 in his book Medical Nemesis,20 we advocate for recognition of a new concept of “digital iatrogenesis” loosely defined as “preventable patient harm and injury that occurs from use of information, services or products delivered or enhanced through the Internet and related technologies.” This definition is broad enough to recognize the potential for the iatrogenic effect emanating from illicit online pharmacies, as well as the diffusion of poor quality and misleading health information online that can result in patient harm.11,21 Our definition also follows on prior efforts aimed at modernizing iatrogenesis to the increasingly technology and electronically

driven medical world through the development of concepts of “technological iatrogenesis” and “e-iatrogenesis” (generally described as emerging errors stimulated by the infusion of technological innovations into complex healthcare systems or electronic sources of errors.)1 Through this process, global governance for e-Health and the Health Internet can occur. Cooperative mechanisms can then be integrated that includes a focus upon inclusiveness of all stakeholders, public and private, domestic and global, patient and provider, to join to work on the global goal of a safe digital health system.9 In concert with efforts by international organizations such as WHO, UN Office of Drugs and Crime, and Interpol, digital iatrogenic harm can both be avoided and proactively eliminated dynamically.22 With improvements in coordination and oversight of public health and law enforcement authorities, this system can be adaptive to address the varying needs of regions and sovereignties against avoidable harm that is the hallmark of iatrogenesis.

Conclusion Most countries recognize Cicero’s important conception: salus populi suprema lex—the health of the people is the highest law.23 As the Internet becomes a more predominant source of health information,24 consumers must be protected from dangerous and illicit online vendors who seek their own profit at the expense of patient safety, often with dire consequences. As our digital environment continues to expand, so does the need to expand the concept of iatrogenesis to respond

1. Technological iatrogenesis: New risks force heightened management awareness. J of Healthcare Risk Mgmt. 2007 Jun;27(4):19–24.

2. Institute of Medicine. To err is human: building a safer health system. Institute of Medicine. 1999.

3. Leape LL, Berwick DM. Five Years After To Err Is Human: What Have We Learned? JAMA. American Medical Association; 2005 May 18;293(19):2384–90.

4. Riedinger JL, Robbins LJ. Prevention of iatrogenic illness: adverse drug reactions and nosocomial infections in hospitalized older adults. Clin Geriatr Med. 1998 Nov;14(4):681–98.

5. Vernon GM. Medication iatrogenesis in the elderly: common, yet preventable. Nurse Pract. 1994 Jun;19(6):27–8.

6. Editorial: Medical nemesis. Br Med J. 1974 Dec 7;4(5944):548–9.

7. Illich I. Medical nemesis. 1974. Journal of epidemiology and community health. 2003. 4 p.

8. Mackey TK, Liang BA, Strathdee SA. Digital social media, youth, and nonmedical use of prescription drugs: the need for reform. J Med Internet Res. 2013;15(7):e143.

9. Mackey TK, Liang BA. Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health. Global

Health. 2013 Oct 16;9(1):45.

10. Health Fact Sheet. 2013 Dec 16.

11. Mackey TK, Liang BA, Kohler JC, Attaran A. Health domains for sale: the need for global health internet governance. J Med Internet Res. 2014;16(3):e62.

12. Liang BA, Mackey T. Searching for safety: addressing search engine, website, and provider accountability for illicit online drug sales. Am J Law Med. 2009;35(1):125–84.

13. WHO. Safety and security on the Internet: Challenges and advances in Member States [Internet].

WHO. 2011 [cited 2013 Mar 5]. Available from: http://www.who.int/goe/publications/goe_security_web.pdf 14. NABP Issues Rogue Online Pharmacy Public Health Alert [Internet]. nabp.net. 2011 [cited 2011 Sep 26].

Available from: http://www.nabp.net/news/nabp-issues-rogue-online-pharmacy-public-health-alert/ 15. Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci. 2011 Nov;100(11):4571–9.

16. Orizio G, Rubinelli S, Schulz PJ, Domenighini S, Bressanelli M, Caimi L, et al. “Save 30% if you buy today.” Online pharmacies and the enhancement of peripheral thinking in consumers. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):970–6.

to the increasingly digital health society.

Policymakers, public health and medical professionals, and the law enforcement community must ensure that health is kept safe online so that we may be able to fulfill Cicero’s ancient but fundamental maxim.

Acknowledgements. Tim K. Mackey received funding from the Canadian Social Sciences and Humanities Research Council in support of research regarding online access to recalled/withdrawn drugs and greatly acknowledges this support.

Tim K. Mackey, MAS, PhD is the Director of the Global Health Policy Institute, an Assistant Professor of Anesthesiology and Global Public Health, an Investigator at the San Diego Center for Patient Safety at University of California, San Diego School of Medicine, and is also the Associate Director for the UC San Diego MAS Program in Health Policy & Law. Bryan A. Liang, MD, JD, PhD is Professor of Anesthesiology and Director of the San Diego Center for Patient Safety at the University of California, San Diego School of Medicine.

17. Liang BA, Mackey TK. Vaccine shortages and suspect online pharmacy sellers. Vaccine. 2012 Jan 5;30(2):105–8.

18. Liang BA, Mackey TK, Lovett KM. Illegal “no prescription” internet access to narrow therapeutic index drugs. Clin Ther. 2013 May;35(5):694–700.

19. Liang BA, Mackey TK, Archer-Hayes5 AN, Shinn LM. Illicit online marketing of locaserin before DEA scheduling. Obesity. 2013 Mar 20.

20. Wright P. Ivan Illich : The Lancet [Internet].

The Lancet. [cited 2014 Apr 29]. Available from: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)12233-7/fulltext 21. Mackey TK, Liang BA, Attaran A, Kohler JC. Ensuring the future of health information online.

Lancet. 2013 Oct 26;382(9902):1404.

22. Mackey TK, Liang BA. Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism. BMC Med. 2013;11:233.

23. Alment A. To coin a phrase. BMJ. 2000 Jul 29;321(7256):272.

24. Fox S. Pew Internet: Health [Internet]. pewinternet.org. 2013 [cited 2013 Feb 14]. Available from: http://pewinternet.org/Commentary/2011/November/Pew-Internet-Health.aspx

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HEALTH HIGHLIGHTS

Iatrogenesis and Causality in Psychological Injury and Law: Concepts and Recommendations

By Gerald Young, Ph.D., and Jenny X. Wang Iatrogenesis in psychology refers to the process in which mental health workers generate a mental health symptomology, condition, or disorder through their demeanor, assessment, diagnosis, advice, comment, treatment, or other intervention. In the area of psychological injury and law, iatrogenesis is one part of the multifactorial causality of patients’ psychiatric and/or psychological status. These causal factors are event related (pre-event, event, and post-event), as well as systemic (litigation distress, the insurance process, and the adversarial divide between plantiff and defense). Patients, assessors, treatment providers, and others in the psychological injury and law system need to be aware of all these issues in order to deal with them in an effective and ethical manner.

Iatrogenesis is a term that originated in medicine but is quite applicable to psychology.

For purposes of this article, I conducted a literature search in PubMed, and the number of articles tagged with the term approached 30,000.

PsychInfo, the search engine for psychology, provided a little over 100 tagged articles. Rees pointed out that the prevention of iatrogenic psychological harm is just as important as of physical harm.1 Medically, the term iatrogenesis concerns a harm induced by medical advice or treatment given to patients by medical doctors. The harm would not have arisen but for the intervention or advice.2 For the discipline of psychology, Melton, Petrila, Poythress, and Slobogin give a definition of iatrogenesis involving a disorder precipitated, induced, or exacerbated by a mental health worker’s attitude, evaluation, comment, or intervention.3 Making an incorrect diagnosis or missing a relevant diagnosis can be iatrogenic. From a psychological perspective, an integrated definition of iatrogenesis is that it consists of a product and a process. First, it generates an iatrogenic illness, disease, disorder, or condition through its harmful process.

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Second, the interaction of the patient and the mental health worker is iatrogenic if the demeanor, assessment, diagnosis, advice, and/or intervention of the latter adversely impacts the former psychologically.

The present paper examines iatrogenesis in an area of psychology in which it is addressed frequently: psychological injury and law. The latter is a relatively new area that has coalesced within the last 10 years especially with the advent of the journal Psychological Injury and Law.4, 5, 6, 7 Psychological injuries refer to conditions such as posttraumatic stress disorder (PTSD), chronic pain, and mild traumatic brain injury (mTBI) that result from events at claim (e.g., motor vehicle accidents (MVAs); work injuries), and that lead to legal actions, such as tort or worker compensation claims. When they are valid, the psychological injuries involved are multifactorial in their causality.8, 9, 10, 11, 12, 13 Part of the causal nexus might include iatrogenic effects. At the same time, these should be viewed as just one systemic effect among several that impact the patient (e.g., the insurance process, the adversarial divide). Moreover, the full system picture includes variables deriving from the patient.

For example, they might experience litigation distress, they might have vulnerable histories or personalities, or they might be unconsciously or consciously exaggerating or even feigning (e.g., malingering).

Historically in the field, Schultz provided a list of best practice standards in a biopsychosocial approach that includes recognition of iatrogenic (medically-generated) and litigation factors.5 Call discussed the stressful nature of the legal process on psychological injury claims. He noted that the evidence does not support the claim that psychological symptoms improve after completion of the litigation process.14 Bryant and Harvey found that litigation status had little effect on the maintenance of PTSD, return to work, and so on.15 Call argued that litigation can contribute to and maintain psychological trauma.15 When this happens, it is “jurisogenic” or “critogenic,” which are terms akin to iatrogenic. Young and Kane concurred, but added that the whole insurance process (from starting a claim and treatment to potentially going to court) might be iatrogenic.16 Young and Kane presented a multifactorial framework on the causality of psychological injury.13,18 Part of the context involved the factor of iatrogenic psychotherapy. The overall model includes pre-existing, causal event, and postevent outcome factors.

Schatman commented on an article by Perret and Rosen.17, 18 Perret and Rosen addressed the overreliance of pain physicians on opioid analgesics in primary treatment, despite the lack of sufficient evidence bases in chronic opiod therapy. Schatman referred to iatrogenesis when he noted the problems of potential safety issues involved. This could happen both to particular individuals and to society, in general. The concerns of Perret and Rosen and Shatman echo those of Illich.19, 20 Aside from describing clinical iatrogenesis, he also described social iatrogenesis and cultural iatrogenesis.

Aside from clarifying the definition of

psychological iatrogenesis, the goal of the present paper is to describe the overall system in which iatrogenesis takes place in the context of psychological injury and law. The next part of the paper describes other constructs related to iatrogenesis in the latter system.

Other Terms Tables 1 and 2 present the major terms of the present paper, with each considered as an important source of influence and biases on psychological injury. Young noted that “litigation distress” refers to iatrogenic or stressful factors in the insurance and legal process, which add to patient stresses and complicate recovery.13 The psychological injuries of survivors have been referred to as a “compensation neurosis;” however, there is insufficient evidence to support this claim. For example, their injuries generally do not magically heal after they receive their financial settlements (see Call reviewed above).

Young examined systemic issues in causality assessment, pointing to the types of stresses associated with the insurance process.9 With respect to the patient side of the equation in the insurance process, Young especially dealt with the issue of malingering.13 However, the interpretation of exaggeration could indicate increasing symptomology and desperation, that is, it could be that litigation distress is an issue to consider.

That is, in litigation distress, or the insurance process, the evaluee might also be improperly influenced by the litigation process and iatrogenic factors. A plaintiff might fear that her or his genuine injuries are not being acknowledged, which could exacerbate the injuries. The defense examination might be perceived as confrontational and the patient’s behavior could reflect a desire to be heard. Or, to the contrary, insurance exams and defense medicolegal might be stressful for the evaluee because of fear that fabrication and deception (malingering) would be exposed.

In general, Young noted that the system in

which a person with Table 2: Factors Contributing to Difficulties in Evaluations: psychological injures Litigation/Iatrogenic functions might be replete with bias.13 Typically, this refers to evaluee bias, such as response bias in testing, but also it could refer to the adversarial divide; for example, evaluators might be influenced by confirmatory bias.

Young referred to the difficulty in assessing problematic presentations and neurosis” should be resurrected.22, 23, 24, 25 The performances in evaluees.13 The concept of difference between compensation neurosis and grey zone applies to evaluees who present malingering is that the presence of internal and perform in an ambiguous way or who are motivations is much more than the external being indeterminate in their presentation and incentives for the former but for the latter, performance. For example, at one extreme, a cry external incentives constitute the sole motivator. for help might be at play. However, at the other Young added that the iatrogenic potential in extreme, even a mild or minimal exaggeration the insurance process also might derive from might be totally consciously fabricated for insurers or in Insurer’s Examination (IE).13 financial gain.

Stress for the evaluee could come from many The next part of the paper reviews recent corners of the system. publications on the multiple systemic factors that Bender and Matusewicz examined the area affect psychological conditions and disabilities of postconcussive syndrome (PCS).26 They in psychological injury cases. They illustrate the noted that there are iatrogenic and “jurisogenic” problems in dealing with those types of cases, factors involved. In contrast, Merten and including in terms of iatrogenesis.

Merckelbach opined that negative response bias Systemic Factors Influence Outcome in in evaluees especially indicate uncooperativeness, Psychological Injury lack of genuine presentation, etc.27 Iverson and Lange showed that assessment Young cited Deary, Chalder, and Sharpe, complications in psychological injury cases who presented a cognitive-behavioral model include expectation effects, which, in this of medically unexplained symptoms (MUS).10, case, means that survivors believe that certain 28 Young noted that Johnson argued in MUS symptoms will develop inevitably as a result that chronic stress can lead to the stress control of their injury.19 Vanderploeg, Belanger, and system going awry.10, 29 Chronic stress creates Kaufmann described the concept of nocebo the conditions for decline in health condition; effect in psychological injury (mTBI leading see McEwen and Lasley and their concept of to PPCs).20 Nocebo effects refer to the mere allostatic load.30 expectation that treatment or intervention will At the conceptual level, the biopsychosocial harm or lead to the creation of or increase approach to psychological injuries includes symptoms. a systemic or forensic component to the Table 1: Major Terms in Pscyhology and Law Bootzin and Bailey model. In Young, the systemic and forensic examined three specific aspect of somatization refers to the host of psychological treatments iatrogenic factors in the insurance process that are intended to produce and in medicolegal proceedings.10 Similarly, positive therapeutic effect.21 Kirmayer and Taillefer had integrated forensic However, the converse of components into their model of somatoform negative outcomes occurred symptoms.31 (i.e., for critical incident stress Conclusion debriefing for PTSD, group Iatrogenesis is a commonly encountered therapy for adolescents concept in medicine. Although it is less with conduct disorders, and prevalent in psychiatry and psychology, it should psychotherapy for dissociative not be disregarded. In the area of psychological disorder). injury and law, iatrogenesis is encountered when Hall and Hall proposed that treating professionals and disability examiners the concept of “compensation unjustly dismiss valid claims or promote invalid Fall 2014 Volume 14, Issue 1

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claims. Iatrogenesis should be considered as part of a larger system in which litigation distress and other stresses from the insurance process impact the complainant. At the same time, individuals might unduly exaggerate or even malinger about their symptoms and impairments (perhaps due to attorney coaching). It remains difficult to tease out the effect of iatrogenesis on the development of psychological injuries, such as chronic pain, posttraumatic stress disorder (PTSD), and propagation of mild traumatic brain injury (mTBI) into a persistent postconcussive syndrome (PCS). These conditions and other factors that might develop after an event, such as in a worker’s compensation case, reflect multifactorial causality. A biopsychosocial model combined with a forensic one is the best way to understand the causation, conditions, and

treatment of psychological injuries. Iatrogenesis can fit nicely as one factor in this type of model.

As for recommendations in dealing with iatrogenesis in the context of psychological injuries, all parties in the system should be aware of its potential presence and pernicious effects (and, of course, many are well-versed and ethical). Psychological iatrogenesis has been given little consideration in the literature compared to medical iatrogenesis. But its effects could be just as harmful. Iatrogenesis is part of a multifactorial complex system that patients have to learn about and deal with. However, treatment providers have to be equally aware of iatrogenesis and related factors. The mental health of patients deserves nothing less. Patients require best ethical practices in dealing with them from all parties in the system involved.13

Gerald Young, Ph.D., C. Psych. is an Associate Professor in the Department of Psychology at Glendon College, York University (in Toronto, Canada).

Aside from his practice, he has authored or co-authored six books, and he has authored multiple articles. He is Editor-in-Chief of the journal Psychological Injury and Law.

1. Rees, C. (2012). Iatrogenic psychological harm.

Archives of Disease in Childhood, 97, 440446.

2. Iatrogenesis (n.d.). In Wikipedia. Retrieved April 17, 2014, from http://en.wikipedia.org/ wiki/Iatrogenesis 3. Melton, G. B., Petrila, J., Poythress, N. G., & Slobogin, C. (2007). Psychological evaluations for the courts: A handbook for mental health professionals and lawyers (3rd ed.). New York: Guilford Press.

4. Koch, W. J., Douglas, K. S., Nichols, T. L., & O’Neill, M. L. (2006). Psychological injuries: Forensic assessment, treatment, and law. New York: Oxford University Press.

5. Schultz, I. Z. (2003). Psychological causality determination in personal injury and workers’ compensation contexts. In I. Z. Schultz & D. O. Brady (Eds.), Psychological injuries at trail (pp. 102-125). Chicago, IL: American Bar Association.

6. Young, G., Kane, A. W., & Nicholson, K. (2006). Psychological knowledge in court: PTSD, pain, and TBI. New York: Springer Science + Business Media.

7. Young, G., Kane, A. W., & Nicholson, K. (2007). Causality of psychological injury: Presenting evidence in court. New York: Springer Science + Business Media.

8. Young, G. (2007). Causality: Concepts, issues, and recommendations. In G. Young, A. W. Kane, & K. Nicholson (Eds.), Causality of psychological injury: Presenting evidence in court (pp. 49-86). New York: Springer Science + Business Media.

9. Young, G. (2008a). Causality and causation in law, medicine, psychiatry, and psychology: Progression or regression? Psychological Injury and Law, 1, 161-181.

10. Young, G. (2008b). Somatization and medically unexplained symptoms in psychological injury: Diagnoses and dynamics. Psychological Injury and Law, 1, 224-242.

11. Young, G. (2010). Causes in the construction of causal law: A psycho-ecological model.

International Journal of Law and Psychiatry, 32, 73-83.

12. Young, G. (2011). Erratum to: Trends in psychological/psychiatric injury and law: Continuing education, practice comments,

recommendations. Psychological Injury and Law, 4, 56-87. [Originally published in 2010 in Psychological Injury and Law, 3, 323-355.]

13. Young, G. (2014). Malingering, feigning, and response bias in psychiatric/ psychological injury: Implications for practice and court.

Dordrecht, Netherland: Springer Science + Business Media.

14. Young, G., & Yehuda, R. (2006).

Understanding PTSD: Implications for court.

In G. Young, A. W. Kane, & K. Nicholson (Eds.), Psychological knowledge in court: PTSD, pain, and TBI (pp. 55-69). New York: Springer Science + Business Media.

15. Call, J. A. (2003). Liability for psychological injury: History of the concept. In I. Z. Schultz & D. O. Brady (Eds.), Psychological injuries at trial (pp. 40-64). Chicago, IL: American Bar Association.

16. Bryant, R. A., & Harvey, A. G. (2003). The influence of litigation on maintenance of posttraumatic stress disorder. The Journal of Nervous and Mental Disease, 191, 191-193.

17. Young, G., & Kane, A. W. (2007). Causality in psychology and law. In G. Young, A. W. Kane, & K. Nicholson (Eds.), Causality of psychological injury: Presenting evidence in court (pp. 13-47). New York: Springer Science + Business Media.

18. Schatman, M. E. (2011). Editorial: The suppression of evidence-basis in pain medicine and the physician-driven quest to re-establish it. Pain Medicine, 12, 1358-1360.

19. Perret, D., & Rosen, C. A. (2011). A physician driven solution – the Association for Medical Ethics, the Physician payment Sunshine Act, and ethical challenges in pain medicine. Pain Medicine, 12, 1361-1375.

20. Illich, I. (1974). Medical nemesis: The expropriation of health. London: Calder & Boyars.

21. Iverson, G. L., & Lange, R. T. (2012).

Traumatic brain injury in the workplace.

In S. S. Bush & G. L. Iverson (Eds.), Neuropsychological assessment of workrelated injuries (pp. 9-67). New York: Guilford Press.

22. Vanderploeg, R., Belanger, H. G., & Kaufmann, P. M. (2014). Nocebo effects and mild traumatic brain injury: Legal implications.

Psychological Injury and Law. 23. Bootzin, R. R., & Bailey, E. T. (2005).

Understanding placebo, nocebo, and iatrogenic treatment effects. Journal of Clinical Psychology, 61, 871-880.

24. Kennedy, F. (1946). The mind of the injured worker: Its effects on disability periods.

Compensation Medicine, 1, 19-21.

25. Miller, H. (1961a). Accident neurosis. British Medical Journal, 1, 919-925.

26. Miller, H. (1961b). Accident neurosis. British Medical Journal, 1, 992-998.

27. Hall, R. C. W., & Hall, R. C. W. (2012).

Compensation neurosis: A too quickly forgotten concept? Journal of the American Academy of Psychiatry and the Law, 40, 390398.

28. Bender, S. D., & Matusewicz, M. (2013).

PCS, iatrogenic symptoms, and malingering following concussion. Psychological Injury and Law, 6, 113-121.

29. Merten, T., & Merckelbach, H. (2013a).

Symptom validity testing in somatoform and dissociative disorders: A critical review.

Psychological Injury and Law, 6, 122-137.

30. Deary, V., Chalder, T., & Sharpe, M. (2007).

The cognitive behavioral model of medically unexplained symptoms: A theoretical and empirical review. Clinical Psychology Review, 27, 781-797.

31. Johnson, S. K. (2008). Medically unexplained illness: Gender and biopsychosocial implications. Washington, DC: American Psychological Association.

32. McEwen, B., & Lasley, E. N. (2003). Allostatic load: When protection gives way to damage.

Advances, 19, 29-44.

33. Kirmayer, L. J., & Taillefer, S. (1997).

Somatoform disorders. In S. M. Turner & M. Hersen (Eds.), Adult psychopathology and diagnosis (pp. . New York: Wiley.

34. Rogers, R. (2008a). An introduction to response styles. In R. Rogers (Ed.), Clinical assessment of malingering and deception (3rd ed., pp. 3-13). New York: Guilford Press.

35. American Psychiatric Association. (2013).

Diagnostic and Statistical Manual of Mental Disorders: DSM-V (5th ed.). Washington: American Psychiatric Association.

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Jenny X. Wang received her H. B. Sc in mental health from the University of Toronto (Scarborough Campus) in 2013, and is currently working with Dr. Young at his practice. She has aided Dr. Young in his most recent book, and his presentation on PTSD and malingering.

HEALTH HIGHLIGHTS

Innovating to End Death and Disability of Our World’s Mothers

By Thomas F. Burke, MD, FACEP and Roy Ahn, MPH, ScD Pregnancy-related death and disability affects 15-20 million women worldwide each year, most of which are in developing countries.1 Tragically, many leading killers of women, such as post-partum hemorrhage, are preventable. Our team at Massachusetts General Hospital has embarked on a decade-long mission to address maternal mortality and morbidity in resource-limited settings around the world. We have emphasized the development of contextuallyappropriate, low-cost innovations to address maternal health in geographies ranging from Kenya to Nepal. Our Every Second MattersTM portfolio of maternal health initiatives is aligned with our host countries’ national strategies for maternal health and is informed by the best implementation research possible. Elucidating what has worked with our programs in resource-limited settings may provide lessons for health policymakers, and in the process, advance our goal of eradicating pregnancy-related deaths from the planet.

All 139 midwives raised a hand skyward in response to the question, “How many of you have seen a mother die from post-partum hemorrhage?” It was sobering, and it is still haunting. If you live in Sierra Leone today, one of those hands would be about someone you know and love – your mother, sister, daughter or wife.

Worldwide, 1,400 women die every day from pregnancy-related causes.2 This mortality is second only to HIV/AIDS.3 And, for each woman who dies from pregnancy, 50-100 suffer from long-term illnesses or disabilities.2 It is estimated that pregnancy-related death and disability affects 15-20 million women worldwide each year. The number one cause is uncontrollable postpartum hemorrhage (PPH).1 The vast majority of these women live in our world’s poorest countries, and the consequences are staggering. When young mothers die or become disabled, the quality of life of children, families, and their communities suffers in virtually every measureable aspect.1,3,4,5,6 The shackles of poverty tighten with each maternal death.

The maternal mortality for a region is described as a ratio of the number of

women that die per 100,000 live births. In the beginning of the 1900s, the maternal mortality ratio (MMR) in the United States was estimated at 1,000 deaths per 100,000 live births. By 2005 the MMR in the United States had been reduced to 11.7 Similar declines were seen in Europe and other developed nations over the same time frame. However, in 2014 there are places on earth where 1 in 6 women die in her lifetime from pregnancy-related causes. In South Sudan, Afghanistan, and Sierra Leone the MMR is as high as 2,054.8 In many other nations the MMR hovers around 1,000. There is no greater health inequality on earth today; for each and every woman that dies or becomes disabled, the climb out of poverty becomes less possible for families, communities and ultimately the nations in which they live.

The decline in maternal deaths in the most developed countries has been carefully studied, and is due largely to three welldescribed pillars: 1) Giving birth in the care of a trained birth attendant; 2) Access to comprehensive emergency obstetrical care (cesarean section, blood transfusion, and antibiotics); and (3) Access to family planning

(birth control).9 However, despite no mystery to the causes of, and solutions to, maternal deaths on our planet in 2013, uncontrolled postpartum hemorrhage took the lives of an estimated 130,000 young mothers and disabled another 2.6 million.10 The consequences of these lost and injured mothers are measured in increases in children’s death rates, decreases in children’s education, and steep losses in families’ and communities’ economic stability. Poor communities lose their greatest drivers toward economic empowerment and prosperity when they lose their mothers.1,3,4,5,6 The questions that naturally emerge beg for understanding: why does this disturbing inequity remain, and what can we do to eliminate the millions of unnecessary deaths and injuries of mothers? For starters, the raw truth is that a focus on women’s health has lagged far behind other priorities over the past 100 years. It is only in the past 20 years, with the founding of organizations and ecosystems such as the White Ribbon Alliance; the Partnership for Maternal, Newborn, and Child Health; the Bill and Melinda Gates Foundation; Women Deliver; and others, and the focus placed by way of Millennium Development Goal 5, that we have seen the emergence of a global agenda on maternal health. Over the past two decades, careful analysis of the countries and communities where women remain most vulnerable tells us that while developed world solutions provide considerable insights into challenges and opportunities for improvement, each country and region also requires locallyowned solutions that are appropriate from skilled human resource, technical (e.g., equipment), logistical (e.g., distances), and cultural standpoints. Additionally, in order for solutions to subsequently gain integration into community and regional health behaviors, strong supporting national policies must be put in place.

Innovating to End Maternal Deaths Our team began its focus on maternal survival Fall 2014 Volume 14, Issue 1

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in 2004 after meeting the First Lady of Zambia at the Harvard Kennedy School. Then First Lady Maureen Mwanawasa directly requested that we help the Zambia Ministry of Health reduce their sobering MMR (1 in 16 women were losing their lives from pregnancy). We quickly learned that in a country that then held a population of 12 million, less than 15 obstetricians, poor transportation services, and very little of any of the three pillars required for maternal health, solutions would have to be creative, contextual, locally- owned, and might look quite different than solutions in developed nations. Over those first few years we would witness countless attempts by others to import developed-world solutions, which almost always would lead to far more harm than good; they would have little hope for community integration, affordability, sustainability, and national scaling. Over the time that we supported the Zambian Ministry of Health to create their national strategy for maternal health we gained critical insights into what it really takes to disrupt the status quo and truly make a difference for good.

In 2009 we were asked by the World Bank, as shepherds of a Multi-Donor Trust fund (MDTF), to help develop a national community-based strategy to address the nine leading killers of mothers, newborns, and children in South Sudan (Maternal, Newborn and Child Survival, or MNCS). We subsequently developed the MNCS package, which included an intensive case-based training program, a low-cost kit of re-usable commodities, and a pictorial checklist memory aid (most health care providers are illiterate).11 Perhaps the greatest challenge was to ask ourselves how we could possibly address PPH, the main culprit of maternal deaths.

PPH deaths in South Sudan mostly occur at remote community locations, virtually all of which suffer from extreme poverty and a lack of the most basic infrastructure. One in two women in South Sudan dies or becomes injured from pregnancy related causes in her lifetime. There is no health condition or disease more crippling to a nation’s women on earth today, than pregnancy to the women of South Sudan. This burden even exceeds the combined consequences of violence and HIV. After landscaping every corner on earth, we combined what we knew worked in the developed world with a variation of what some others have tried, and then adjusted this in order to accommodate for the unique setting of South Sudan – our innovation must not rely on other equipment and must be reusable, locally available, ultra-inexpensive,

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easy to use, and have few to no downsides.12 Our first ultra-low cost uterine balloon was born, around which we created a package for training, policy and integration, Every Second Matters for Mothers and Babies™-Uterine Balloon Tamponade (ESM-UBT).

As we rolled out MNCS (with ESM-UBT embedded) in South Sudan, we kept hearing anecdotes of women’s lives saved by the UBT. Prior to the UBT, there had been a complete lack of accessible and effective methods to treat PPH when bleeding was uncontrolled by basic interventions. Eventually, we went to look for ourselves, and undertook a rigorous case study in a limited geography in the state of Eastern Equatoria. This study revealed compelling examples of women pulled from the threshold of death.13 It appeared then that our innovation was potentially a very simple, rapid, affordable, and effective point-of-care method to manage severe PPH. In order to prospectively test the ESMUBT, during 2013 we partnered with UNICEF, PATH, the Ministry of Health of Kenya and the Kisumu Medical Education Trust to roll out ESM-UBT across 65 facilities in Kenya. To date, although critically ill from uncontrolled PPH at the time of UBT placement, all 49 women who have received UBT have survived without complications.

In fact, as a result of this data the Kenyan Ministry of Health has formally integrated the UBT device and training package into the Kenyan national policy for PPH. In the last few months of 2013, we were asked by the countries of Senegal, Nepal, Ghana, and Sierra Leone to introduce and implement ESM-UBT into their countries.

The Bill and Melinda Gates Foundation, USAID, and the governments of Norway, the UK, and Canada all have brought resources forward to assist in this implementation effort.

Every day now we are hearing of women who did not die and did not become disabled.

A Second Innovation for Maternal Survival An additional major cause of death from pregnancy is obstructed labor and no availability of cesarean section. The consequences of obstructed labor include: death from complete obstruction, a worn out uterus (atonic) that then succumbs to hemorrhage (PPH), infection, and/or fistula where the bladder and rectum walls have eroded and are permanently connected to the vagina.14 All of these circumstances lead to disastrous consequences for mothers, families and communities.

In order for a mother in a resourcelimited setting to undergo cesarean section,

three components must be simultaneously available: an operating theatre, someone with surgical skills, and someone with anesthetist/ anesthesia skills. Interestingly, it is often that third piece that is missing, and causes a mother to die or become disabled. In fact, the World Health Organization and others have raised the flags and rung the alarm bells, fully recognizing the worldwide critical human resource gap in anesthesia services.15 The solutions proposed to date have mostly been business-as-usual, developedworld imports: two year anesthetist programs, or four to five year anesthesia training.

Neither of which will remotely fill this gap in any of our lifetimes. Thus, an innovation was needed.

The region surrounding the site of our Massachusetts General Hospital Western Kenya Health Innovations research center is home to 5.8 million people. Thirty-four operating theatres serve this region, and while there are doctors with surgical skills attached to each of these operating theatres there are only 18 anesthetists.16 A minimum standard is 5 anesthetists per theatre. This is a crisis, similar to most other poor regions of the world, and there is no simple solution in sight.

However, as is often the case, a solution may in fact lay right before us in the form of an ultra-safe and ultra-low cost anesthetic agent known as ketamine. Ketamine is a unique anesthetic agent that has been used safely worldwide for over 40 years.17 If one looks closely and between the cracks, ketamine is used by providers all over the world today in a clandestine but very utilitarian fashion.

Examples include surgeons in Sierra Leone who work alone giving injections of ketamine and then proceed with their operations, midwives in Zambia who give ketamine and then perform emergency cesarean sections, and doctors in Kenya who tell their nurse to give ketamine before they undertake a surgical procedure. Ketamine is out there, being used sporadically, but its implementation is disorganized and lacks a policy framework.

Therefore, in October 2013, together with our Kenyan colleagues, we designed the ESMKetamineTM package with the intent being that trained health care providers (doctors, nurses, or clinical officers) could then safely provide ketamine anesthesia in support of painful procedures and emergency cesarean section. This package includes a customized ESM-Ketamine kit plus a four day training program for health providers that covers basic pharmacology, appropriate monitoring, Helping Babies Breathe®, and case-based learning through didactics and operating

theatre time. In the 6 weeks since our initial implementation at 2 hospitals, each with an operating theatre but no anesthetist or anesthesia availability, over 45 surgical cases have been successfully completed with no complications. Each of these is another life saved and/or improved.

Where Do We Go From Here?

Many great ideas fail despite the very best of intentions, hopes and dreams. A great idea will miss its opportunity to serve humanity if it is not integrated at all levels of society. An emerging academic field called “Implementation Science” utilizes research to promote understanding of the factors that lead to successful health interventions in real-world settings. The National Institutes of Health notes that “the intent of implementation science and related research is to investigate and address major bottlenecks (e.g. social, behavioral, economic, management) that impede effective implementation, test new approaches to improve health programming, as well as determine a causal relationship between the intervention and its impact.” This type of systems-level thinking is needed to improve global maternal health. In the cases of our ESM-UBT and ESM-Ketamine initiatives, we have rigorously thought through the multitude of systems-level issues required for successful and sustainable implementation.

This has meant carefully ensuring training uptake by local health providers, establishing

data collection and analysis procedures, developing a local business model for the ESM portfolio, working hand-in-hand with key community stakeholders to change community norms about maternal health (i.e., that mothers need not die during childbirth), and working closely with Ministries of Health to inform policy change at the local and national levels.

Just a few weeks ago, we stood on the shores of Sierra Leone, one of the most desperately poor nations on earth and where 1 in 10 mothers dies in her lifetime from pregnancyrelated causes. The view was extraordinary in a most disturbing way—massive ocean liners from the US, the UK, China, and elsewhere were making their hauls. These highly technical and complex behemoth ships are feats of enormous human ingenuity. And here they were, loading up with the riches of diamonds, gold, bauxite, rutile, and iron ore.

We were told that this view was the same every day and that soon oil tankers would join in order to harvest a new find. Yet, in this mineral-rich country of 6 million, 70 per cent of the population survives on less than one dollar per day and one in 10 mothers is dying in pregnancy. We can do better than allowing wealth to be harvested while simultaneously ignoring the people to whom it belongs.

Through asking the right questions and a willingness to think far outside of traditional lines, solutions for our world’s pregnant women are undoubtedly close at hand.

Eradicating global maternal deaths is a bold goal, but so, too, was the goal of eradicating smallpox from the planet – a goal that was ultimately achieved in 1979. Successful innovative solutions will require integration of expertise in public health, technology, public policy, business, and local context, and doing so may result in one of the great achievements of our lifetime.

1. Murray CJL, Lopez AD. Health dimensions of sex and reproduction. Cambridge: Harvard University Press, 1998.

2. Garg BS, Chhabra S, Zothanzami SM. Safe motherhood: social, economic, and medical determinants of maternal mortality. Women and Health Learning Package, developed by The Network: TUFH Women and Health Taskforce. Second edition, September 2006.

Available at http://www.the-networktufh.org/ sites/default/files/attachments/ basic_pages/WHLP%20Safe%20Motherhood. pdf [last accessed 15 January 2014].

3. Koblinsky M, Chowdhury ME, Moran A, Ronsmans C. Maternal morbidity and disability and their consequences: neglected agenda in maternal health. J Health Popul Nutr. 2012 June;30(2):124-130.

4. Lawn JE, Lee AC, Kinney M, Sibley L, Carlo WA, Paul VK, Pattinson R, Darmstadt GL. Two million intrapartum-related stillbirths and neonatal deaths: where, why, and what can be done? Int J Gynaecol Obstet. 2009 Oct;107 Suppl 1:S5-18, S19.

5. Bloom DE, Fink G. The economic case for devoting public resources to health. IZA Policy Paper No. 57, May 2013.

6. Storeng KT, Murray SF, Akoum MS, Ouattara F, Filippi V. Beyond body counts: a qualitative

study of lives and loss in Burkina Faso after ‘near-miss’ obstetric complications. Soc Sci Med. 2010 Nov;71(10):1749-56.

7. WHO, UNICEF, UNFPA, The World Bank.

Maternal Mortality in 2005: Estimates developed by WHO, UNICEF, UNFPA and The World Bank. Geneva: World Health Organization, 2007.

8. WHO. Country Cooperation Strategy at a Glance: South Sudan. May 2013. Available at http://www.who.int/countryfocus/cooperation_strategy/ccsbriefs_sdn_en.pdf.

9. WHO. Maternal mortality: fact sheet no. 348.

May 2012. Available at http://www.who. int/mediacentre/factsheets/fs348/en/ [last accessed 15 January 2014].

10. IntraHealth International. Voices from the field: preventing postpartum hemorrhage.

Available at http://www.intrahealth.org/page/ preventing-postpartum-hemorrhage .

11. Nelson BD, Ahn R, Fehling M, Eckardt MJ, Conn KL, El-Bashir A, Tiernan M, Purcell G, Burke TF. Evaluation of a novel training package among frontline package among frontline maternal, newborn, and child health workers in South Sudan. Int J Gynaecol Obstet. 2012 Nov;119(2):130-5.

12. Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine

balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):514.

13. Nelson BD, Stoklosa H, Ahn R, Eckardt MJ, Walton EK, Burke TF. Use of uterine balloon tamponade for control of postpartum hemorrhage by community-based health providers in South Sudan. Int J Gynaecol Obstet. 2013 Jul;122(1)27-32.

14. Dolea C, AbouZahr C. Global burden of obstructed labor in the year 2000. Evidence and Information for Policy (EIP). Geneva: World Health Organization, July 2003. Available at http://www.who.int/healthinfo/statistics/ bod_obstructedlabour.pdf.

15. Abdullah F, Troedsson H, Cherian M. The World Health Organization Program for Emergency Surgical, Obstetric, and Anesthetic Care: from Mongolia to the future. Arch Surg.

2011 May;146(5):620-623.

16. World Bank. Report on anesthesia services in Kenya. 2013 [in press].

17. Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):44961.

Thomas F. Burke, MD, FACEP, FRSM, is Chief of the Division of Global Health & Human Rights, Department of Emergency Medicine, Massachusetts General Hospital. He is also Assistant Professor of Surgery at Harvard Medical School and member of the Harvard Medical School Admissions Committee.

Roy Ahn, MPH, ScD, is Director of Research and Innovation in the Division of Global Health & Human Rights, Department of Emergency Medicine, Massachusetts General Hospital.

He is also Instructor in Surgery at Harvard Medical School.

Fall 2014 Volume 14, Issue 1

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STUDENT CONTRIBUTIONS

Photo illustration by Melinda Song

and vaccine services became more scarce.5,4 Despite reduced availability and quality of care, Greeks were forced to pay more for their health care than they had before the crisis, spending over €25.7 million in 2011 in

By Elise M. Baranouski copayments for outpatient services that had This paper seeks to document the health effects of the Greek financial crisis. formerly been covered by social insurance.4 The hardship of the crisis as well as the austerity measures put in place to Additionally, unofficial user fees in the health combat it are found to have negatively impacted public health, personal system, known as “informal payments,” health, and mental health within the country. Despite these sobering proliferated during this time. These payments findings, NGOs have made promising and innovative advances in countering amounted to bribes that patients had to the negative health effects, and the government is actively working towards pay in order to skip long lines, receive care, the creation of policies that will bring this crisis within a crisis to an end. and obtain drugs, tainting6 the system with “institutionalized bribery.” Reforms turned a blind eye to this normalized corruption On December 7th, 2013, the Greek promising responses from NGOs inspire of the health system and added to patients’ parliament voted to approve a budget plan optimism for humanistic reform in the burdens by increasing formal user fees and for the year 2014 that included austerity cuts future.3 drastically cutting wages for health workers, of over €3 billion.1 While this announcement The multibillion-euro loans given to leading to the unintended consequence was met with weary resignation in Greece, Greece by the EU throughout the economic of doctors requiring even greater informal few would have foreseen such drastic crisis imposed harsh spending cuts and payments from patients to supplement low measures when Greece’s economic crisis austere reforms of social services, and the wages.7 silently began five years earlier. Greece’s health sector was no exception. The Greek To explore the extent of the humanitarian economy began collapsing in 2008 and government accepted a €110 billion loan in problem in Greece today, it is vital to look the nation found itself with huge public May of 2010 and a €130 billion euro loan beyond changes in health systems to analyze and private debts. In order to finance in February of 2012 from the “Troika,” changes in health outcomes. Some of the these debts, ordinary people lost – and are composed of the IMF, the European Central earliest signals of population health decline continuing to lose – access to decent health Bank, and the European Commission. In included the disease outbreaks beginning care and preventive health services.2 The accepting these loans, Greece in 2009, when cases of economic tragedy has been met by an equally also had to accept neoliberal Reforms turned non-imported malaria were devastating health tragedy as budget cuts loan conditions, cutting a blind eye to reported in Greece for the imposed by detached Eurozone leaders have back public sector services, first time since 1974.8 Within this normalized decimated social services in Greece. This liquidating public assets, less than 18 months, West Nile paper seeks to illustrate the causes of this and essentially removing corruption of the Virus appeared in humans health crisis as well as the effects of the crisis itself from the market health system. for the 8first time in Greece’s and subsequent health system weakening on through deregulation.4 While history. The outbreaks were public health, personal health, and mental measures such as raising electricity rates first attributed to the presence of foreign health, then close with recommendations for and postponing pension benefits made it immigrants, serving to further marginalize remedying the current situation. Ultimately, hard for average Greeks to carry on with a the most marginalized group in Greek the application of austerity policies to comparable quality of life, these measures society. However, research soon showed that health is found to be, in the words of Greek also resulted in declining quality in health care the malaria was native and non-imported, scientific scholar Thomais Kakouli, “brutal as salaries in public health were drastically and the reemergence was actually triggered and self-defeating” in Greece today, but reduced, hospitals were closed and merged, by austerity cuts to mosquito spraying.4, 9 A

The Impact of the Greek Financial Crisis:

The Neoliberal Response and Resulting Public Health Challenges

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sudden rise in HIV cases was also found to be a result of slashed budgets, particularly the funding reduction for needle exchange programs, overturning initial claims that immigrant prostitutes were to blame.9, 10 Bonovas and Nikolopoulos observed that the crisis has simultaneously impacted transmission and response, increasing transmission rates for these infectious diseases by lowering living conditions and constraining the health system’s capacity for prevention and control.8 Moving from the aggregate level of health indicators to the individual level, measures of self-rated health have consistently fallen throughout the crisis along all demographic and socioeconomic groups.11 Some increases in illness, particularly in acute myocardial infarctions and respiratory illness, can be attributed directly to the stress or worsened living conditions engendered by the financial crisis.12, 13 Other declining health trends may be due to the significant increase in the number of people reporting not having seen a doctor when necessary.2 This phenomenon is largely attributed to the inconveniences of the overburdened post-crisis medical system, such as long waiting times and farther distance to travel due to the closing and merging of hospitals.7 The 32% increase in stillbirths between 2008 and 2010, interrupting a 42-year continuous decline, is most likely a result of this disincentive to seek preventative care.14Additionally, despite the Greek diet being one of the healthiest in the world, the invasion of cheap fast food leads many of Greece’s poorer families to abandon the relatively more expensive Mediterranean diet in this time of crisis and contributes to an increase in obesity rates.15 Unfortunately, the crisis has also had inequity-enhancing effects with regard to health.10 Economic conditions generally impact health outcomes through two channels: reduced income, leading to a lower ability to manage disease and a greater likelihood of making unhealthy lifestyle choices, and reduced government spending, affecting the quality and availability of public health services.11 While lower income groups clearly face the greatest burdens from further reductions to income, they are also the ones most affected by reduced government spending, given the nature of the spending cuts endorsed by the Troika.

Specifically, there have been very significant cuts to sickness and disability benefits that have disproportionately impacted the worst off in society.10 A study of the informal payment system, whose prevalence has

Measures of self-rated health have consistently fallen throughout the crisis along all demographic and socioeconomic groups. been indirectly attributed to the Troika reforms, discovered these payments to be regressive, systematically imposing a greater burden on lower income groups.16 This harsh reality is best explained by Paul Farmer’s theory of structural violence, in which “economically driven processes and forces…conspire…to constrain agency,” wherein agency refers to the individual’s capacity to make choices.17 This structural violence is also being perpetrated against the elderly, as severe reductions in pension eligibility have left many elderly Greeks with “no choice but to forego basic lifesaving drugs and healthcare monitoring in order to afford food and heating.”3 The political and economic structure is truly failing to help the low-income population, as further evidenced by the inability of most unemployed people to get health insurance through the social insurance funds, despite the fact that this group now constitutes too large a portion of the populace for the government to ignore. However, the Greek government has promised to acknowledge and combat this structural violence in the future by granting free access to treatment in public hospitals to those who experience long-term unemployment.7 It is a promising step, but the question remains whether or not the government will actually follow through on this promise and whether it will dedicate similar effort to battling the informal payment system.

For Greeks throughout the socioeconomic spectrum, mental health is the aspect of public health that has been hit the hardest by this crisis. The number of psychiatric patients is rapidly increasing while the number of health workers and clinics dealing with these issues is seeing a corresponding decrease due to cuts.3 Most notably, there have been dramatic increases in the numbers of suicides and attempted suicides since the crisis began, especially amongst men, married people, people with low interpersonal trust, and people experiencing financial strain.2, 12 An analysis of the new, post-crisis cases of suicide and suicidal ideation exhibit a decreased threshold of psychopathology for suicidality, demonstrating that people who would not biologically be predicted to be suicidal have been deeply affected by external impacts from the crisis and thus pushed to that brink.18 Declining mental health has been

increasingly observed among the employed in Greece, so while unemployment and the accompanying financial stress are surely responsible for some of the mental health effects observed in the Greek population, they cannot be entirely responsible.19 Pushing beyond the well-documented effects of economic deterioration on mental health, Bhavsar and Bhugra focus on accompanying social changes that may be equally damaging.

They note that the increased inequality that often accompanies economic deterioration, as it currently does in Greece, leads to more suicides, depression, and anxiety even when all other factors are taken into account.20 Furthermore, they found that degradation of traditional identity and of social cohesion, evidenced by the sentiments and protests of the Greek people, can lead to a more individualistic social environment and increased mental illness.20 Finally, health sector reforms have led to increased formal and informal payments on expensive antidepressants, cementing a vicious circle in which depression and personal financial insecurity have become mutually reinforcing.21 In conclusion, the current economic crisis in Greece poses serious threats to mental and physical health within the country – even outside of the country due to outbreaks of infectious disease – and troublingly, these threats have most severely materialized for the poor and marginalized in Greek society. It is time for the neoliberal policies pushed upon Greece by the Troika to be meaningfully evaluated for their real effects on health. Improving health in Greece will require structural reforms that do more than just throw money at the current system, and improving health equity will require that the government address informal side payments and institute fairer transactions in the health sector.6 While NGOs such as Praksis are stepping in to provide health care clinics for migrants and other marginalized people in Greek society, this NGO intervention is not sustainable and the health system must find a way to reabsorb the roughly 30% of Greeks currently using street clinics rather than the hospital system.22, 2 The health system needs to be restructured from a fragmented system with an excess of specialists to a more integrated system that emphasizes task sharing and the institution of the family Fall 2014 Volume 14, Issue 1

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The current economic crisis in Greece poses serious threats to mental and physical health within the country–even outside of the country due to outbreaks of infectious disease–and troublingly, these threats have most severely materialized for the poor and marginalized in Greek society. doctor.23 For example, one report advocated for opening medical lab management to non-medical scientists to reduce costs and improve efficiency.24 Another important reform involves integrating cheaper generic drugs into the pharmaceutical system, as Greece currently has some of the lowest levels of generic drug penetration in all of Europe, with physicians adding to the problem by almost exclusively prescribing brand name versions.10, 25 This could also help correct for cases of “noncompliance” in which patients have no choice but to stop taking their pills because of financial inability.26 Other necessary reforms would include integrating mental health care into

primary health care and providing labor market support programs proven to decrease unemployment-related suicides.27 Ultimately, the government should heed the warning given by scholar Thomais Kakouli: “You have no right to obtain credit by degrading the health of your compatriots and by sending to an early grave the most vulnerable among us”.3 The government needs to follow the lead of NGOs who are prioritizing the people most harmed and most stigmatized by the crisis, such as the NGO OKANA that is opening “drug consumption centers” where homeless drug users with no access to health care are supervised and given drug treatment.28

1. Maltezou R. Greek parliament approves 2014 budget plan. Reuters. 2013 Dec 7 [cited 2013 Dec 11].

2. Kentikelenis A, Karanikolos M, Papanicolas I, Basu S, McKee M, Stuckler D. Health effects of financial crisis: omens of a Greek tragedy.

Lancet.2011 [cited 2013 Dec 11]; 378: 14571458.

3. Kakouli T. “Troika” mandated austerity and the emerging healthcare crisis in Greece: An open letter to the Greek government. British Medical Journal Observations. 2013 Apr 30 [cited 2013 Dec 11].

4. Kondilis E, Giannakopoulos S, Gavana M, Ierodiakonou I, Waitzkin H, Benos A. Economic Crisis, Restrictive Policies, and the Population’s Health and Health Care: The Greek Case. Public Health Ethics. 2013 [cited 2013 Dec 11]; 103(6): 973-980.

5. Frangos C, Frangos C, Sotiropoulos I, Orfanos V, Toudas K, Gkika E. The Effects of the Greek Economic Crisis on Eating Habits and Psychological Attitudes of Young People: A Sample Survey Among Greek University Students. Proceedings of the World Congress on Engineering, 1. 2012 [cited 2013 Dec 11].

6. Lewis M. Informal Payments and the Financing of Health Care in Developing and Transition Countries. Health Aff.2007 [cited 2013 Dec 11]; 26(4): 984-997.

7. WHO Regional Office for Europe. Summary: Health, health systems, and economic crisis in Europe: Impact and policy implications. 2013 [cited 2013 Dec 11].

8. Bonovas S, Nikolopoulos G. High-burden epidemics in Greece in the era of economic crisis: Early signs of a public health tragedy.

J Prev Med Hyg. 2012 [cited 2013 Dec 11]: 169-171.

9. Kentikelenis A, Karanikolos M, Papanicolas I, Basu S, McKee M, Stuckler D. Effects of Greek economic crisis on health are real.

British Medical Journal Letters. 2012 Dec 21 [cited 2013 Dec 11].

10. Ifanti A, Argyriou A, Kalofonou F, Kalofonos H. Financial crisis and austerity measures in Greece: Their impact on health promotion policies and public health care. Health Policy.

2013 [cited 2013 Dec 11];113(1-2): 8-12.

11. Zavras D, Tsiantou V, Pavi E, Mylona K, Kyriopoulos J. Impact of economic crisis and other demographic and socio-economic factors on self-rated health in Greece. Eur J Public Health.2013 [cited 2013 Dec 11]; 23(2): 206-210.

12. Palmer R. In Greece, Public Health Declines as Unemployment Rate Rises. International Business Times. 2013 Mar 22 [cited 2013 Dec 11].

13. Karamanoli E. Financial crisis harms respiratory health in Greece. Lancet Respir Med.2013 [cited 2013 Dec 11]; 1(7): 511-512.

14. Vlachadis N, Kornarou E. Increase in stillbirths in Greece is linked to the economic crisis. British Medical Journal Letters. 2013 Feb 19 [cited 2013 Dec 11].

15. Miller J. Greece’s diet crisis: Greeks abandon traditional foods, and an obesity epidemic is the result. Marketplace. 2012 Oct 29 [cited 2013 Dec 11].

16. Kritikou P, Latsou D, Yfantopoulos J. PHP40 Health Care Reforms Under Economic Crisis: The Greek Case. Value Health.2011 [cited 2013 Dec 11]; 14(3): A18.

17. Farmer P. On Suffering and Structural Violence.In: Partner to the Poor. Berkeley: University of California Press; 2010. p. 29-50.

18. Stavrianakos K, Pachi A, Paplos K, Nikoviotis D, Farouraki E, Tselebis A, et al. 1704 – Suicide attempts before and during the financial crisis in Greece. Eur Psychiatry.2013 [cited 2013 Dec 11]; 28(Supplement 1).

19. Vandoros S, Hessel P, Leone T, Avendano M. Have health trends worsened in Greece

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It is up to the Greek government and its Troika of international funders to recognize the health consequences of their policies and implement humanistic approaches that refuse to sacrifice health and dignity “at the altar of austerity.”10, 28 Acknowledgments: Many thanks to John Quattrochi, Doctoral Candidate at the Harvard T.H. Chan School of Public Health, for his feedback during the initial drafting of this paper.

Elise M. Baranouski is currently a senior at Harvard College where she studies Government with a secondary focus in Global Health & Health Policy. She worked in Athens, Greece with the nongovernmental public health institute Prolepsis during the summer of 2013. as a result of the financial crisis? A quasiexperimental approach. Eur J Public Health.2013 [cited 2013 Dec 11]; 23(5): 727731.

20. Bhavsar V, Bhugra, D. Globalization: Mental health and social economic factors. Glob Soc Policy. 2008 [cited 2013 Dec 11]; 8: 378-396.

21. Economou M, Madianos M, Peppou LE, Patelakis A, Stefanis CN. Major depression in the era of economic crisis: a replication of a cross-sectional study across Greece. J Affect Disord. 2013 [cited 2013 Dec 11]; 145(3): 313.

22. Phillips L. Ordinary Greeks turning to NGOs as health system hit by austerity. EU Observer.

2011 Jun 10 [cited 2013 Dec 11].

23. Oikonomou N, Tountas Y. The Greek economic crisis: a primary health-care perspective. Lancet.2011 [cited 2013 Dec 11]; 377(9759): 28-29.

24. Kazanis I. Reforming the Greek health system: A role for non-medical, clinical bioscientists.

Health Policy.2013 [cited 2013 Dec 11]; 109(1): 46-51.

25. Vandoros S, Stargardt T. Reforms in the Greek pharmaceutical market during the financial crisis. Health Policy.2013 [cited 2013 Dec 11]; 109(1): 1-6.

26. Davlouros P, Gizas V, Stavrou K, Raptis G, Alexopoulos D. DES thrombosis related to antiplatelet therapy noncompliance: A consequence of the Greek financial crisis. Int J Cardiol.2013 [cited 2013 Dec 11]; 168(4): 4497-4499.

27. Wahlbeck K, McDaid D. Actions to alleviate the mental health impact of the economic crisis. World Psychiatry. 2012 [cited 2013 Dec 11]; 11: 139-145.

28. Maltezou R, Pomeroy R. Crisis-hit Greece sets up first “drug consumption” centre. Reuters.

2013 Nov 25 [cited 2013 Dec 11].

STUDENT CONTRIBUTIONS

Targeting National Emergency Department Overuse: A Case for Primary Care, Financial Incentives, and Community Awareness

By Christina A. Nguyen, Jenny A. Shih*, Katerina V. Lin*, Oludamilola A. Aladesanmi* *

These authors contributed equally.

Patients seek care in the emergency department (ED) for many reasons, including non-urgent conditions that could be treated in a primary care physician’s (PCP) office or alternative health facility. Convenience, need-blindness, and resourcefulness draw patients towards the ED, and lead to ED overuse. In this article, we outline a comprehensive and integrated approach that includes specific solutions and quality improvements to overcome the excessive use of EDs for non-urgent conditions. We target three critical components of the healthcare system: 1) hospitals and other physician groups, 2) insurance companies, and 3) patients. Our recommendations include expanding access to primary care, offering financial incentives for both patients and physicians to reduce unnecessary ED visits, and fostering patient awareness of alternative health care options through community health workers (CHWs) and mobile worksite programs.

Over the last few years, the number of the ED.2 However, primary care centers emergency department (ED) visits has often lack timely appointments as well as increased by 30% from about 96 million after-hours care, and as a result patients visits in 1995 to 115 million in 2005 (Figure experience poor coordination of care in 1).1 Despite the increase in ED visits, the contrast to care received through EDs. This number of hospitals with operating EDs aspect can especially become problematic has declined by 8%.1 Increasing ED use when the patients have chronic conditions. can be largely attributed to a “push” factor Consequentially, the difficulty of receiving drawing patients away from primary care care at primary care centers and the ability centers and a “pull” factor attracting them to receive immediate care at hospital EDs to emergency services. 45% of patients fuels the increased demand for emergency cite access barriers to primary care as their care services. Factors like convenience, reason for using the ED, but only 13% need-blindness, and resourcefulness attract of patients have conditions that require patients to EDs. However, an excess of

patients coming to the ED with non-urgent conditions makes it difficult for hospitals to achieve maximum efficiency and provide the best quality of care possible. Overcrowding creates longer waiting times, decreases physician productivity and efficiency, and eventually contributes to the increasing risk for poor health outcomes.3 Physicians cut down the time they spend with each patient and in some cases have to divert incoming patients to alternative hospitals.4 Furthermore, the overuse of ED places an additional burden on the overtaxed health care system, and contribute to the $38 billion worth of wasteful health care spending every year.5 In this article, we evaluate current interventions to address the problem and investigate the causes of the national problem of ED overuse. We then suggest a comprehensive and integrated approach that includes specific solutions and quality improvements to overcome the excessive use of EDs for non-urgent conditions.

Current Interventions The literature describes several interventions that have been implemented in recent years to address the issue of ED overuse.

Efforts to increase capacity of non-ED settings, such as mobile worksite health clinics, have had mixed results.2,6-7 Increased access to non-urgent centers and the use of managed care, in which the patient agrees to visit only certain physicians, have led to reductions in ED use; however, the extent to which these policies translate into better patient outcomes and usage of appropriate care centers for non-urgent conditions is unknown.6 Additionally, several studies have suggested that patient awareness Fall 2014 Volume 14, Issue 1

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efforts through informational booklets and are patient-centered medical homes that urgent care centers and retail health clinics. in-person education sessions may lead to allow health care professionals to interact Urgent care centers and retail health clinics better health outcomes, with no significant directly with the patients to foster stronger provide alternative ways for patients who adverse events.6,8 However, there is little doctor-patient relationships. These homes need quick care to see PCPs. They provide information available regarding the impact would offer comprehensive care services walk-in care for acute illness and injury of patient awareness on the ability of and be able to coordinate healthcare services care, and often provide quicker care than seeking appropriate care. across specialties. Piloted studies of these the ED.10,11 Moreover, the cost of a visit On the other hand, by limiting the homes have shown that this system leads to is the same, or even lower than a regular services that are covered by insurance, reductions in ED use by 37%.2 Increasing physician’s appointment or ED visit.12-13 insurance companies may successfully the number of these patient-centered Urgent care clinics have been shown to decrease the demand for certain medical homes and implementing team-based care reduce ED overuse by 48%, a statistic services, such as the use of ED. The 1970s can improve medical care can emphasize that demonstrates their potential to divert RAND health information exchange (HIE) care coordination as well as prevent patients patients from overburdened EDs.14 experiment found that more generous from overusing the ED. Aligning Financial Incentives health insurance is associated with increased Second, we suggest that primary care One of the biggest barriers to solving medical use, including centers extend clinic the ED issue is misalignment of financial that of EDs. For One of the biggest hours. Many patients incentives between patients, providers, and example, the expansion flock to the ED because insurance companies. In conjunction with barriers to solving of Medicaid in Oregon primary care offices are hospital efforts to increase access to primary the ED issue is led to a 40% increase in not open during late care services, insurance companies should overall ED use over an hours or weekends. offer financial incentives for both patients misalignment of 18-month period.9 To By offering extended and physicians to reduce unnecessary ED financial incentives take advantage of the hours, primary care visits. influence of insurance between patients, physicians (PCPs) Currently, hospitals and providers are on demand for care, would not only be not incentivized to address the issue of ED providers, and insurance companies able to reach a greater overuse. First, hospitals want to take in as insurance companies. number of patients, many patients as possible, so reducing the have implemented incentives to motivate but also reduce the wait number of patients’ ED visits conflicts patients to limit non-urgent ED visits. Data time between scheduling appointments. with their incentive to maximize income. show that such incentives can successfully This is especially important for patients with Secondly, hospitals typically make more help prevent ED overuse.6 chronic conditions who need continuous money by admitting elective patients who Much of the literature addresses the care that is only possible through their PCPs are often insured and who come for wellproblems and responsibilities attributed instead of case-specific visits to the ED. reimbursed surgeries, rather than patients to health systems and providers, but fails Third, we propose an expansion of who have variable insurance statuses to elaborate on patient responsibilities. alternative care clinics (Figure 2), such as into the ED. Third, hospitals have a legal Moreover, there is a lack of literature that evaluates the effectiveness of a combination of efforts, especially in light of better quality Figure 1. Trends in numbers of emergency departments and related visits, United of care and health outcomes. To address the States, 1995-2005 complexity of the ED overuse problem, we propose a multi-pronged approach that targets three critical components of the healthcare system: 1) hospitals and other physician groups, 2) insurance companies, and 3) patients.

Expanding Access to Primary Care Healthcare providers should expand access to primary care in existing primary care centers and alternative facilities, such as urgent care centers. These can provide healthcare for the non-life-threatening conditions for which patients sometimes come to the ED. To improve access to existing primary care services, we propose the expansion of healthcare homes, clinic hours, and alternative care clinics.

First, we propose caring for patients within healthcare home environments, which can reduce the need for these patients to seek care in the ED. These environments Source: Nawar et al., 2007

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Harvard Health Policy Review

obligation according to the Emergency maximize their income. to contact a representative sample of Medical Treatment and Active Labor Act Fostering Patient Awareness the community. As such, educating a few (EMTALA) to provide necessary care to Many patients overestimate the severity of people would optimally create a network all patients who of communication walk into the ED.15 Efficient change must come about by first getting the through neighbors.

As a result of population to understand the urgency of fixing a universal alsoCHWsfocus would these factors, an on overcrowded ED threat to their everyday health. targeting minority makes it more likely or region-specific that patients who are uninsured or have their health problems and consequently populations within their communities. non-urgent concerns will leave the ED seek care at an ED when less expensive For example, if Latinos in a certain area before getting treated. alternative care is appropriate.16 Patient are more likely to overuse the ED, then We propose that insurance companies education could reduce ED visits by making the volunteers could focus on being able instate new financial incentives for both patients more aware of alternative health to provide verbal or written information the providers and patients so that these centers and advising them to seek medical in Spanish, while taking note of different incentives align with reductions in ED care in the ED only when necessary. medical beliefs that their culture might use. They should incentivize the use of To implement patient education and have. This will make our approach more alternative care by rewarding patients outreach, we advocate the use of community culturally, linguistically, and contextually who utilize urgent care clinics and other health workers (CHWs), trained community appropriate for target populations.18 In alternative care centers with lower co-pays. members who are able to provide informal specific neighborhoods such as lowA system that rewards patients rather than health-related services, to bridge the gap income urban and rural populations where penalizes them can potentially decrease the between the private and public sectors of there is extremely low access to primary demand for ED services. Also, in addition health.17 CWHs and volunteers would reach care, we would furthermore suggest the to creating patient financial incentives, out to members of the community through implementation of mobile worksite health insurance companies should also instate various events and social gatherings that programs to offer preventive care services.19 payment reform for providers. Performance make information about preventive services Preventive care services may include measures such as patient ED utilization or and available care services more relatable and essential medical screenings—including appointment wait times could be used to fuel accessible. For example, some would offer tests for hypertension, cholesterol, blood a pay-for-performance or global payment pamphlets at gatherings after church services glucose, HIV/AIDS, and Body Mass Index model. Providers would be incentivized to with information about averting common (BMI) assessment—and education on risks, achieve their performance standards and to illnesses, while others would go door-to- symptoms, nutrition, and self-care.19 reduce unnecessary use of ED in order to door in sectors of certain neighborhoods Discussion Implementing our solutions successfully involves being able to motivate each Figure 2. Characteristics of Ambulatory Care Centers, by Type player in the American healthcare system to contribute to change. Leading others to change, however, is not always easy.

Patients are often unwilling to change their habits after having gone through numerous years of relatively healthy lives. Therefore, efficient change must come about by first getting the population to understand the urgency of fixing a universal threat to their everyday health. Good ideas come into fruition after understanding people’s norms and then changing them through active people-to-people interactions; this involves a “grassroots” approach from the community, in which everyone is aware of the perceived value of a change and can continue to educate one another.20 Communities thus have the ability to form networks in which health behaviors and connections can spread.21-23 This approach of tackling the ED overuse as a community problem can help address the barrier of mobilizing changes in patient behavior. In order to draw patients away from seeking non-urgent care in the ED, we must educate patients to utilize Source: California Health Care Foundation, 2007 Fall 2014 Volume 14, Issue 1

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Our three-pronged approach for addressing the ED overuse problem aims to improve the quality of care for patients in both urgent and non-urgent situations.

rooms continue to provide the highest quality of care for those who need it the most.

primary and alternative care centers and adopt preventive care practices. Since patients spend a disproportionate amount of time managing their health outside of professional healthcare providers, education and patient awareness tactics would take a step closer towards the ideal of having a “flipped” healthcare system, in which patients are the main drivers behind their own healthcare.24 Ultimately, our three-pronged approach for addressing the ED overuse problem aims to improve the quality of care for patients in both urgent and non-urgent situations.

Patients with urgent conditions can receive more timely and efficient care in the ED, while those with non-urgent conditions can find their needs met more appropriately at alternative sites. Reductions in overcrowded EDs will allow health professionals to devote more time to each patient and provide more patient-centered care. Increasing patient awareness and services by instituting mobile health clinics can lead to screening minority groups and enhancing the accessibility of populations that may have difficulty receiving primary care services. Reduced wait times in the ED will also provide a less

stressful atmosphere conducive to safer and more effective practices.

The problem of ED overuse in the US is a national emergency that needs to be addressed immediately. New policies must be implemented to assure that emergency

Acknowledgements. We would like to thank the teaching staff of GHHP 50: The Quality of Health Care in America. We thank Dr. Rosenthal, Dr. Jha, Ashley Fryer, and Hummy Song for their teaching and advice.

Christina Nguyen is a senior at Harvard College concentrating in Sociology, with a secondary in Global Health and Health Policy.

Jenny Shih is a senior at Harvard College concentrating in Human Developmental and Regenerative Biology and pursuing a Secondary in Global Health and Health Policy.

Katerina Lin is a senior at Harvard College concentrating in Neurobiology and pursuing a secondary in Global Health and Health Policy. Her specific health policy interests include primary health care.

Oludamilola “Dami” Aladesanmi is a senior at Harvard College concentrating in History and Science, with a focus on Medicine and Society, and a secondary field in Global Health and Health Policy.

1. Nawar EW, Niska RW, Xu J. National hospital ambulatory medical care survey: 2005 emergency department summary. Adv Data.

2007; 386: 1-32.

2. Grumbach K, Bodenheimer T, Grundy P. The outcomes of implementing patient-centered medical home interventions: A review of the evidence on quality, access and costs from recent prospective evaluation studies.

Wash¬ington, DC. Patient-Centered Prim Care Collab. 2009.

3. Derlet RW, Richards JR. Overcrowding in the nation’s emergency departments: complex causes and disturbing effects. Annals of Emergency Medicine. 1999; 35:63-8.

4. Sternberg A. The overuse of America’s Emergency Rooms. Annals of Health Law. 2011; 20:70-77.

5. National Priorities Partnership (NPP), National Quality Forum. Reducing Emergency Department Overuse: A $38 Billion Opportunity. 2010.

6. Morgan SR, Chang AM, Alqatari M, Pines JM. “Non-Emergency Department Interventions to Reduce ED Utilization: A Systematic Review.” Academic Emergency Medicine.

2013; 20:969-985.

7. Weinick RM, Bristol SJ, DesRoches CM. Urgent care centers in the U.S.: Findings from a national survey. BMC Health Services Research 2009; 9:79.

8. McWilliams DB, Jacobson RM, Van Houten HK, Naessens JM, Ytterberg KL. A program of anticipatory guidance for the prevention of emergency department visits for ear pain. Arch Pediatr Adolesc Med. 2008; 162:151–6.

9. Taubman SL, Allen HL, Wright BJ, Baicker K, Finkelstein AN. Medicaid increases emergencydepartment use: evidence from Oregon’s Health Insurance Experiment. Science. 2014; 343:263-8.

10. Yee T, Lechner AE, Boukus E. The surge in urgent care centers: emergency department alternative or costly convenience? Health System Change. 2013; 26:1-6.

11. National Association for Ambulatory Care (NAFAC). Where do I go? The Emergency Room? Or an Urgent Care Center? 2012.

12. Blue Cross Blue Shield (BCBS). Alternatives to Emergency Room Care. Immediate Medical Care: ER or Other Options? 2014.

13. Urgent Care Association of America. Urgent Care Industry Information Kit. 2013.

14. Merritt B, Naamon E, Morris SA. The influence of an urgent care center on the frequency of ED visits in an urban hospital setting, Am J Emerg Med. 2000; 18:123-125.

15. Zibulewsky J. The Emergency Medical Treatment and Active Labor Act (EMTALA): what it is and what it means for physicians.

Proc (Bayl Univ Med Cent). 2001; 14:339-48.

16. Kelly L, Birtwhistle R. Is this Problem Urgent?

Attitudes in a community hospital emergency

room. Can Fam Physician. 1993; 39:1345– 1352.

17. Zuvekas A, Nolan L, Tumaylle C, Griffin L. Impact of Community Health Workers on Access, Use of Services, and Patient Knowledge and Behavior. J Amb Care Mgnt.

1999; 22:33–44.

18. Locks LM, Pandey PR, Osei AK, Spiro DS, Adhikari DP, Haselow NJ, Quinn VJ, Nielsen JN. Using formative research to design a context-specific behaviour change strategy to improve infant and young child feeding practices and nutrition in Nepal. Matern Child Nutr. 2013.

19. The Family Van. Harvard Medical School.

2007. Available from: http://www.familyvan. org/.

20. Gawande A. Slow Ideas. The New Yorker.

2013.

21. Christakis NA, Fowler JH. The collective dynamics of smoking in a large social network.

New England Journal of Medicine. 2008; 358:2249-2258.

22. Christakis NA, Fowler JH. The spread of obesity in a large social network over 32 years.

New England Journal of Medicine. 2007; 357:370-379.

23. Smith KP, Christakis NA. Social networks and health. Ann Rev Sociol. 2008; 34:405-429.

24. Bisognano M. Flipping Health Care. Global Health and Health Policy 50 Lecture 23.

Harvard University. Presented April 22, 2014.

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