IEU - Alliance

Striving for patient safety NOW

INTERNATIONAL DEVELOPMENTS

EU Commissioner Healthcare John Dalli heard by European Parliament, 14 th Jan. 2010

European Commission positive towards blacklist of dysfunctioning physicians, July 7th 2009.

10 commandments for minimizing medical errors by Dr Michael Guiliano, October 6th 2008.

Spring 2008: publication Canadian Guidelines for Disclosure.

Let doctors pay for their medical errors and not the patients! September 12th 2007

Is Dutch healthcare twice as good? Nivel/Emgo report on adverse events in Dutch hospitals, AprMay 07

Pediatricians want to disclose, February 2007

More literature on exclusion by physicans of litigious patients from medical care, USA and NZ 2006.

Physicians exclude litigious patients from medical care, JAMA 2005.

WHO developments

New Zealand: open and honest approach and no Fault Compensation system

Veterans Health Administration adopts disclosure and remedial medical care for iatrogenic patients

Denial and cover-up of medical errors by physicians acknowledged by Dutch medical association

EU Commissioner Healthcare John Dalli heard by European Parliament, 14 th Jan. 2010

"Patients first. Consumers first" : Designate Commissioner John Dalli heard by the European Parliament
John Dalli, Designate Commissioner for Health and Consumer Policy, was heard by the European Parliament on 14 January 2009. "Patients first. Consumers first" was the motto Dalli used as a key heading during the hearing. Please read on for the details of the hearing and further information on reactions from the public health community.

On 14 January, the European Parliament held the hearing of John Dalli, Commissioner Designate for Health and Consumer Policy.

Background information on the process

On 27 November 2009, the European Commission President José-Manuel Barroso together with the Council proposed John Dalli as Designate Commissioner for Health and Consumer Policy. President Barroso defined the portfolio allocated to John Dalli in a mission letter and indicated the various services that he would have at his disposal in order to accomplish his tasks.

Following the ordinary procedure, John Dalli then submitted his Curriculum Vitae to the attention of the European Parliament, as well as well as his declaration of interests.

The ENVI and IMCO Committees provided John Dalli with their priorities for the Health and Consumer Protection areas, underlining the following specific elements in the area of public health :

- "Interconnection of health and environment

- Ensuring coherence in EU policies

- Measures to address the impact of the demographic challenge (with the increase in the ageing population) on public health and healthcare systems in Europe

- Measures to improve the independence of patients’ groups, including in relation to financing

- Legislative action on indoor air quality

- Legislative action to protect workers from environmental tobacco smoke and to update the Tobacco Labelling Directive"

On the same occasion, the European Parliament addressed a series of written questions to all designate commissioners. John Dalli presented his written answers.

The Hearing on 14 January 2010

The European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI), as well as delegations from the Internal Market and Consumer Protection Committee (IMCO) and Agriculture and Rural Development Committee (AGRI) held during three hours the hearing of Commissioner Designate John Dalli.

In his general introductory address to the Members of the European Parliament, John Dalli insisted that the underlying theme of his work will be "patients first, consumers first".

His vision includes European citizens living longer and healthier lives and consumers influencing the policies that concern them. Whilst particularly concerned by the question of sustainability of healthcare systems in Europe, John Dalli believes in the need to invest more in prevention and health promotion and mentioned he’d want to see this reflected in the budgets for health, with more than just 3% allocated to prevention matters.

"There is no reason that poor people should suffer from poor health" is a statement that was welcome by MEPs with applauses, even though we didn’t get to hear what concrete action John Dalli plans in order to tackle the increasing health inequalities in Europe.

John Dalli tackled several issues during the hearing, either through his address or as an answer to the various questions from MEPs. Here are a few topics on which we had the opportunity to hear John Dalli’s views :

- Pharmaceutical policy with a focus on the formerly called Pharmaceutical Package and its three components : Information to Patients, Pharmacovigilance and Falsified Medicines (please read the full article on this topic here

- Food and nutrition policy, with a focus on the Food Information to Consumers Regulation and rules on the cloning of animals - the full article is available here

- Negotiation on health files with the Council, more information is availablehere

Moreover, on consumer policy, Mr Dalli said he sees his role as "the guardian of consumers" at the level of the College of Commissioners.

On a number of key files for the European Parliament, John Dalli expressed views that were generally welcome by the various MEPs. For example, on the so-called Patient’s Rights Directive (Directive on Patients’ Rights in Cross-border Healthcare), he agreed with Radvilé Morkunaité-Mikuléniné MEP (EPP, LI) that the work on this piece of legilsation needs to move forward, whilst he assured that he make a lot of efforts in order to foster an agreement at the Council level, but also among the EP and the Council.

Answering a more general question from Linda McAvan MEP (S&D, UK), coordinator of the S&D group in ENVI, he said that he would like his legacy after five years to show he has been tough on issues like alcohol, smoking and obesity. He then insisted on the need to provide more information and on education as a key tool leading to healthier lifestyles. "The earlier we get at children, the better it is", he added and indicated that "proper budgets are needed" in that regard.

Source.

European Commission positive towards blacklist of dysfunctioning physicians, July 7th 2009.

The Ministry of Healthcare of the Netherlands issued a press-release stating that Abraham Klink, Minister of Health of the Netherlands met with the members of the European Commission in Sweden.
At this meeting he proposed the development of a European black list containing the names of dysfunctioning physicians in the European Community.
Apparently Commissioner Vassilou of Healthcare as well as the majority of the members of the European Commission supported the necessity of publishing this black list, in order to ensure quality of healthcare and safety for patients.
The European Commission will prepare the list, respecting legal requirements.
Please note that the IEU-Alliance was the first to publish the need for a European list of disfunctioning physicians in our Manifest 2007.
As soon as further developments are known, the IEU-Alliance will take it upon us to publish.

10 commandments for minimizing medical errors by Dr Michael Guiliano, October 6th 2008.

Dr. Michael Guiliano of the Touro University School Medicine (and Director Neonatalology at the Hackensack University Medical Center) has formulated a list of 10 principles to minimize medical errors.
As you can see, one of his main themes is not just put all the trust and power in the doctor's hands, especially a single doctor, and to involve
professionals as well as the patient and relatives in the process and give both a voice and the responsibility to contribute tot he diagnosis (and its correction).

1. I shall not *believe everything I hear* from the doctor

2. I shall first *listen* to the patient

3. I shall *not fall in love* with my first diagnosis

4. I shall *not believe everything I hear* about test results

5. I shall *explain* everything to everyone

6. I shall *involve* the patient in everything.

7. I shall *communicate* with peers precisely

8. I shall *take personal responsibility* for the patient's clinical problem

9. I shall *not believe everything* the consults say.

10. I shall say *"I DON'T KNOW"* regularly and go get the answer

These are based on a growing body of research in both evidence-based medicine and evidence-based management.
They apply to any complex decision where there is uncertainty, people with different levels of power, different information, clashing self-interest,and severe pressure to get things right .However doctors, nurses and patients/relatives should take their responsibilities and seek true cooperation in order to achieve the best level of health care to the benefit of all involved parties, especially the patient.

With many thanks to Helen Haskell.

Spring 2008: publication Canadian Guidelines for Disclosure.

Good news!.On March 18th 2008 the Canadian Institute for Patient Safety has published the first Canadian Guidelines for dealing with victims of medical errors: the Canadian Disclosure Guidelines. Page 34 Appendix E publishes the procedure and checklist. These guidelines are based on respect for the victim which are expressed in the following: priority is given to presenting the facts and of direct arrangement for the safety of the patient and direct measures for follow-up diagnostics and remedial medical care, to limit the damage of the errors. The guidelines also insist on informing the patient that the error will be analysed and which measures will be taken to prevent reoccurence. It is advised to apologize. It seems that these guidelines are more explicit than the Harvard Consensus Report 2006 on which we based our Tell and Repair legal provision. Now these guidelines have to be brougt to practice as soon as possible to the benefit of the present and future victims of medical errors. We sincerely hope that the publication of these guidelines will encourage the medical field to a sense of urgency to implement Tell and Repair as soon as possible as we proposed at the conference of April 23rd 2008 in Utrecht, the Netherlands.
See Report Canadian Disclosure Guidelines 2008 (pdf/1.87MB)

Let doctors pay for their medical errors and not the patients! September 12th 2007

Richard Lord and Dr. Marylou Buyse

We pay for medical errors September 12, 2007 Boston Globe

WHAT IF your mechanic forgot to replace the lug nuts after changing one of your tires and you got into a serious accident when the wheel came off? You wouldn't expect your mechanic to send you a bill for the repairs, would you?

Unfortunately, that's what happens in healthcare and we pay a high price for mistakes.

Eight years have passed since the Institute of Medicine's landmark study, "To Err is Human," which found that as many as 98,000 patients die each year in America's hospitals as a result of medication overdoses, postsurgical infections, and other medical errors. These are preventable deaths, yet medical mistakes cause more deaths than car accidents, breast cancer, or AIDS.

Even when mistakes are not fatal, they can still have devastating results. They can lead to injury, disability, extended hospital stays, or lengthy recoveries. And we often pay twice when errors occur - once for the mistake and again to correct it. Nationally, the cost of preventable medical errors, lost income, and lost productivity is estimated at $17 billion to $29 billion a year.

Employers bear a large part of that expense. In Massachusetts, more than four out of every five insured individuals under the age of 65 receive coverage through an employer. So when preventable errors occur, it is businesses that pay.

Take, for example, routine bypass surgery, which can cost more than $50,000. When a sponge or a surgical instrument is left inside the patient, correcting the mistake can add tens of thousands of dollars to the cost of caring for that individual. These errors should never happen, but are far too frequent and, ultimately, employers are left paying the bill through higher health and disability premiums.

Medical care in Massachusetts is the most expensive in the country - $7,075 per resident is spent every year, compared with the national average of $5,313. Healthcare costs are increasing three times faster than the annual rate of inflation, and the quality of care can vary between and among healthcare facilities.

On many measures, Massachusetts healthcare providers and medical institutions are the envy of the world, but we can do more to improve the quality of care in the state. We can start by raising the bar higher, through public reporting of medical errors and by removing the financial benefit when serious mistakes occur.

Legislation to require public reporting of medical errors that will be heard by the Legislature's Public Health Committee today is a good place to start, and many in the healthcare system have been working to make that information available. Still, we can go farther. The legislation should be revised so that providers are not allowed to bill for the extra costs of treating preventable errors, injuries, and infections that occur in hospitals.

Healthcare entities should not be rewarded financially when such preventable errors occur. Hospital-acquired infections offer one example. An August 2007 report by the state's Betsy Lehman Center for Patient Safety and Medical Error Reduction found that infections contracted during a hospital stay could be causing up to $473 million in medical costs annually in Massachusetts. Meanwhile, there are hospitals around the nation that have driven their infection rates down to zero.

Prohibiting billing for so-called "never events" is another example. These are rare but serious medical errors that should never happen to a patient, such as conducting surgery on the wrong body part, leaving a foreign object in a patient after surgery, or patient death or serious injury resulting from a medication error.

While healthcare facilities currently are required to report major medical incidents to the state, these reports are not readily available or useful to the public. In 2005, the state's Board of Registration in Medicine issued a report that found that healthcare facilities reported 24 never events the prior year, but did not identify the institutions, leaving both patients and the healthcare system unaware where these mistakes occur. We need stronger measures in place to prevent these errors from continuing to happen.

No other industry generates revenue from mistakes. Preventable errors should not be part of the usual cost of healthcare.

Richard Lord is president and CEO of Associated Industries of Massachusetts. Dr. Marylou Buyse is a practicing primary care physician and president of the Massachusetts Association of Health Plans.

© Copyright 2007 Globe Newspaper Company

Is Dutch healthcare twice as good? Nivel/Emgo report on adverse events in Dutch hospitals, AprMay 07

Every single victim by medical errors is one too many.
Even after a medical error avoidable damage can be prevented to iatrogenic patients by providing honest information and adequate remedial care.

Prof.G.van der Wal, Inspector-General of the Inspectorate of Healthcare (www.igz.nl)Netherlands, presents in a video the following conclusions of the report, published April 25th 2007:
In 2004 76.000 persons were unintentionally harmed in Dutch hospitals by medical care. The question is, what is the definition of unintentional harm? Do they mean medical errors?
30.000 persons were damaged by avoidable harm. 6.000 persons were permanently damaged by avoidable harm.
2000 persons died due to preventable medical errors.
This means that the amount of permanently damaged persons by medical errors is twice as high as the amount of victims of road accidents.

The results of this report deviate in a serious way from the results of international research. On one hand the numbers are too high as each victim of medical errors is one too many.On the other hand the numbers are considerably lower in comparison to other countries.
According to this report appr. 2000 persons die by medical errors in hospitals. According to international consensus 50% of medical errors is preventable, so another 2000 persons die by non-preventable errors, whatever these might be. This leads to appr. 4000 persons who die by medical errors in hospitals.
Our extrapolation, see epidemiological survey, based on the international consensus of 1 of 1000 hospitalisations leading to death or disability, led to appr. 8000 persons who die by medical errors per year at hospitilisations in the Netherlands. No one contradicted our numbers.
This research leads to a total of appr. 4000 death per year.
The conclusion should then be that medical care is twice as good in the Netherlands as other countries. Is this realistic????
Or are the results of international research not correct and is the report of the National Patient Safety Agency from the UK: Building a memory, preventing risk, reducing harm and improving patient safety ( 2005) not correct? This does not seem plausible.

We certainly appreciate the openness of the involved hospitals to cooperate with this investigation. However we have found several methodological limitations.

- This research is initiated by the Association of Medical Consultants and is done by two medical research institutes, one originally intended for research on primary care (Nivel) and one connected to Free University Hospital VU Medisch Centrum Amsterdam (Emgo). This constitutes self-assessment, which per definition is not independent.
- Prof. G. Van der Wal is not only one of the main researchers but also Inspector-General of Inspectorate of Healthcare. This causes a severe conflict of interests.
- Apparently a medical ethical commission was not involved.
- This report has been a written on the basis of retrospective research. This means that the objects and methods of research were defined retrospectively. Prospective research is more precise as definitions of objects and methods of research are formulated in advance. This method is more reliable.
- The evaluation of the medical records was done by two consultants for each case. This is too restricted. In other examinations three consultants were involved with a backup of ten other persons.
- The research was done by medical consultants of four medical departments; internal medicine, surgery, neurology and pediatrics. Other specialities were excluded. Thus this implies a limitation of medical expertise.
- The research is only based on review of medical records. The researchers themselves acknowledge that 76% of the medical records of this research was not adequate. This is a well known fact acknowledged by the top lawyer of the Dutch Medical Association Legemaate in his inaugural speech 2006. Also the Healthcare Inspectorate as well as the Medical Association of Consultants and Medical Association confirm that medical records are often inadequate.
Reports written by patients were not included in this research. Several studies acknowledge the importance of reports of medical errors by the involved patients.
- Terminal ill patients sometimes prefer to be with their family at home. Their deaths are not included in this research.
- The research involves unintentional harm. This excludes intentional harm caused by deliberate refusal providing open and honest information on the occurrence of a medical error and of neglect of adequate follow-up diagnostics and adequate remedial medical care to victims of medical errors. Several cases of inadequate hospitalisations leading up to six months without diagnostics nor treatment are known to us.

Conclusion IEU-Alliance
On May 8th 2007 Chief-Inspector patient safety Jan Vesseur of the Inspectorate of Healthcare acknowledged that the numbers of victims of medical errors of the Nivel/Emgo report were incorrect, and should be at least doubled, in order to be realistic.

The research of Nivel/ Emgo is incomplete, not independent and does not meet basic methodological requirements. Adequate independent and true scientific research to examine preventable damage in hospitals is urgently necessary. This is also necessary for medical errors in primary care, medical care in nursing homes, social legislation medical care and psychiatry. We need to know in order to be able to improve. Each victim of a medical error is one too many.

Pediatricians want to disclose, February 2007

5-Feb-2007 JAMA and Archives Journals
Pediatricians willing to disclose medical errors but consider current reporting systems inadequate

Most pediatricians support both reporting medical errors to hospitals and disclosing them to patients' families, but believe formal error reporting systems are inadequate and struggle with personal disclosure, according to survey results published in the February issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

Physicians are encouraged to openly communicate about errors to improve patient safety, according to background information in the article. However, many errors remain unknown to both the medical institution and the patient involved. This could be due to the medical culture of autonomy and individual accountability, the threat of legal action or fear of damage to the physician's professional reputation. Pediatricians face additional challenges in error disclosure because a third party, the patient's parents, are involved.

Jane Garbutt, M.B.Ch.B., Washington University School of Medicine, and colleagues surveyed 439 pediatric attending physicians and 118 pediatric residents in St. Louis and Seattle. The survey, distributed by mail and on the Internet between July 2003 and March 2004, contained 68 questions examining the physicians' attitudes about and experiences with error communication. Types of errors included serious errors, which cause permanent or life-threatening injury; minor errors, which cause harm that is temporary and not life-threatening; and near misses, errors that could have caused harm but did not because of chance or intervention.

Seventy-six percent of the responding physicians agreed that medical errors were one of the most serious problems in health care, and most reported that they had been involved in at least one error: 39 percent a serious error, 72 percent a minor error and 61 percent a near miss. Among the physicians:

- 97 percent believed that serious errors should be reported to the hospital, 90 percent that minor errors should be reported and 82 percent that near misses should be reported

- Most (92 percent) had used a formal error reporting mechanisms, such as an incident report (65 percent)

- Many (74 percent) also used informal error reporting mechanisms, such as telling their supervisors (47 percent) or a senior physician (38 percent), and 72 percent had discussed errors with colleagues

- Only 39 percent thought that current formal error reporting systems were adequate

- 99 percent thought serious errors should be disclosed to patients' families, 90 percent that minor errors should be disclosed and 39 percent that near misses should be disclosed

- 36 percent had ever disclosed a serious error to a patient's family and 52 percent had disclosed a minor error in the past 12 months

- 96 percent of residents and 86 percent of attending physicians believed that disclosing serious errors would be difficult

- 69 percent of residents and 56 percent of attending physicians wanted disclosure training

"While pediatricians endorse reporting errors to the hospital and disclosing errors to patients' families, system changes are required to facilitate these communications," the authors write. "The hospital must facilitate the reporting of errors and near misses by pediatricians so that effective, safer systems of care can be developed and implemented. In additional, open and honest discussions following pediatric errors must occur to maintain and improve patient trust. Such open communications about errors are likely to benefit current and future pediatric patients, their families, pediatricians and the hospital."

### (Arch Pediatr Adolesc Med. 2007;161:179-185. Available pre-embargo to the media at www.jamamedia.org.)

More literature on exclusion by physicans of litigious patients from medical care, USA and NZ 2006.

Comment :
These two articles on New Zealand and the USA describe the refusal of medical care -in terms of avoidance or withdrawal- to litigious patients of ao victims of medical errors.
Various physicians have confirmed that refusal of medical care to litigious patients occurs.
Some physcians do not appreciate assertive patients and regard them as potential adversaries. This is certainly a negative development.
We plead for mutual honesty, transparancy and evidence-based medicine, in order to develop and maintain a positive physician-patient relation.

N Z Med J. 2006 Oct 27;119(1244):U2283
Defensive changes in medical practice and the complaints process: a qualitative study of New Zealand doctors.
Cunningham W, and Dovey S. Department of General Practice, Dunedin School of Medicine, Dunedin. wayne.cunningham@stonebow.otago.ac.nz

AIM: To characterise doctors' responses to complaints.
METHOD: Survey of a systematic sample of New Zealand doctors, and indepth interviews with 12 doctors who recently received complaints.
RESULTS: 714 written survey responses and 12 indepth interviews revealed changes consistent with positive and negative defensive medicine as well as changes in the direction of "good practice". Positive defensive medicine changes were increased investigation and referral rates, active identification of potential problem patients, over-documentation and consenting, and altered approaches to time and workload. Negative defensive medicine changes involved withdrawal from the doctor-patient relationship and particular fields of practice. Good practice changes included reflective practice, greater sensitivity to societal and professional expectations, and initiating systemic change.
CONCLUSIONS: The complaints process in New Zealand has the potential to improve healthcare delivery at a systemic level and to reinforce appropriate standards of professional behaviour, but it may cause individual doctors to practice defensively. Unless an appropriate educational process is allied to the complaints process, defensive medicine may compromise patient care and constrain potential improvements in healthcare delivery overall.
PMID: 17072358 Pub Med

The doctor-patient relationship: A casualty of the medical liability crisis
By Stuart L. Weinstein, MD
Bulletin American Academy of Orthopedic Surgeons, December 2006.
Important parts of the text are printed in bold.

The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns,” reads the AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons.1 But the current medical liability crisis is jeopardizing that relationship on several levels.

The current medical liability crisis has been ongoing for the past five years. Although there has been some progress in passing tort reform on the state level, a federal solution remains elusive. The success of California’s Medical Injury Compensation Reform Act (MICRA) legislation over the past 30 years, and the more recent constitutionally sustained reforms in Texas in 2003, give objective evidence that meaningful liability reform can bring common-sense resolution to the crisis.2 Medical liability insurance premiums may have stabilized, but they remain exorbitant in most states.

National debate on tort reform centers on the two main effects of the crisis—decreasing access to care and increasing health care costs. But the most important aspect of medicine and the delivery of health care—the doctor-patient relationship—is also one of the unintended casualties of the crisis. The evolution of this relationship—a direct result of the current crisis—will affect all aspects of health care for a generation to come. This article briefly addresses the changing doctor-patient relationship and its impact on other aspects of the medical liability crisis.

Turning patients into adversaries
The AAOS Code of Medical Ethics and Professionalism states that: “The physician-patient relationship has a contractual basis and is based on confidentiality, trust, and honesty…The orthopaedist shall not decline to accept patients solely on the basis of race, color, gender, sexual orientation, religion, or national origin or on any basis that would constitute illegal discrimination.” But can a physician decline to accept trauma patients, who evidence suggests are more litigious than other patients, or patients that the physician “perceives” to be litigious? In fact, an increasing number of physicians are doing just that.3,4

Recent articles on the doctor-patient relationship in the current medical liability crisis indicate that physicians are increasingly viewing patients as potential adversaries. This has profound effects on physician behavior, on health care costs (resulting from defensive medicine expenditures), on the distribution of physicians and on the career choices of medical students.

In a 2004 study, researchers reported that 40 percent of Pennsylvania specialist physicians surveyed were dissatisfied with the practice of medicine as a result of the medical liability crisis, and many said that they viewed every patient as a potential lawsuit.5

Residents—regardless of medical discipline—are beginning to reflect similar attitudes. One study examined the effects of the liability crisis on residents who took their training in Pennsylvania. Of 360 residents in anesthesiology, emergency medicine, general surgery, orthopaedic surgery and radiology, 80 percent stated that they viewed every patient as a potential malpractice lawsuit. One-third stated that they were less candid with patients because of medical liability concerns. Sadly, two out of three said they were less eager to practice medicine than they had once been, and nearly 28 percent regretted choosing medicine as a career.6

The impact of the crisis even reaches medical students; according to statistics from the American Medical Association, 95 percent of medical students are aware of the current crisis and almost half say that it played a part in their career choices. Because of the high liability risks associated with the practice of obstetrics and gynecology (Ob-Gyn), approximately one-third of U.S. Ob-Gyn residency slots went unfilled during the last few years.7

The Common Good Web site quotes one emergency physician as saying, “I now view every patient I see as a potential lawsuit” and “The threat of lawsuit is hovering out there, hovering somewhere in the air between me and the patient on the stretcher, invisible but with a presence as strong as a third person sitting and listening to the conversation waiting for the right time to simply come out in the open.” These attitudes profoundly affect the doctor-patient relationship and upset the entire health care dynamic. They also result in increased health care spending and decreased access to care.

Practicing defensive medicine
Doctors who view patients as potential adversaries can contribute to increasing health care costs by practicing defensive medicine. A survey of specialists in Pennsylvania found that 93 percent reported practicing defensive medicine, and 92 percent reported “assurance behavior.”4

Assurance behavior can be defined as “supplying additional services of marginal or no medical value with the aim of reducing adverse outcomes, deterring patients from filing malpractice claims or persuading the legal system that the standard of care was met.” It includes ordering tests (particularly imaging tests), performing diagnostic procedures and referring patients for consultation. Other assurance behaviors include ordering more medications than medically necessary, particularly antibiotics; suggesting invasive procedures—such as breast biopsies—to confirm diagnoses; and performing extensive workups and requiring hospitalization for atypical chest pain in low-risk patients. As the study authors pointed out, the more this practice is perpetuated, the more likely it is to become the “standard of care.”4 Assurance behavior has also been documented in a recent study of emergency physicians.9

The Pennsylvania study also found that 42 percent of surveyed physicians reported “avoidance behavior.”4 Avoidance behaviors reflect physicians’ efforts to distance themselves from sources of legal risk and may include restricting practice, eliminating high-risk procedures and procedures prone to complications (trauma surgery, pediatric surgery, vaginal deliveries, cancer surgery, spine surgery, cranial surgery, aneurysm surgery), and avoiding patients with complex problems or patients “perceived” as litigious. This profoundly affects access for patients in rural areas where alternative choices of care are limited.

In Pennsylvania, 42 percent of specialists have reduced or eliminated high-risk aspects of their practice and 50 percent are likely to do so over the next two years.11

Limiting access
The Institute of Medicine’s recent report on emergency care in the United States documented the critical shortage of specialists in certain areas of the country. As a result, many emergency rooms are closing and patients must travel long distances for basic care.3, 10 Access is also restricted because physicians change their practices, stop doing high-risk procedures, stop taking emergency room duty, and stop taking care of trauma patients.

A survey of AAOS members in four crisis states found that 58 percent have discontinued or limited their emergency room coverage, 33 percent have stopped doing spine surgery and 33 percent have eliminated other high-risk procedures or complicated trauma cases. At the same time, increased referrals to academic health centers placed greater pressure on these facilities.

Nationwide, the two groups most affected by the access issue are women and those who live in rural areas. Women are affected because one in seven Ob-Gyns no longer delivers babies. In some areas, such as Washington, D.C., that number is up to 40 percent. Of those who do deliveries, a significant number will not take any high-risk cases. Women are also affected because of the shortage of physicians willing to read mammograms. Rural residents are affected because of the lack of availability of on-call specialists, which contributes to the closure of emergency rooms and increases the distance patients must travel for basic care.

The U.S. House has repeatedly passed liability reform measures, but these have not passed the Senate, where Republicans have generally supported reform while Democrats have prevented the measure from even coming up for a vote. However, the effects of the crisis are now being recognized even by those senators who have voted against reform.12 During the summer of 2006, both chambers held hearings on medical liability reform.

Without prompt resolution of the current medical liability crisis, the change in the doctor-patient relationship may be irreparable. The practice of “defensive medicine” will establish standards of care that can only lead to continued increases in health care costs.

Stuart L. Weinstein, MD, is chair of the Orthopaedic Political Action Committee. He also serves on the AAOS Medical Liability Committee, representing Doctors for Medical Liability Reform.

References:

AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
Hull MS, Cooper RB, Bailey CW, Wilcox DP, Gadberry GJ, Wallach MD. “House Bill 4 and Proposition 12: An Analysis with Legislative History.” Texas Tech Law Review. Special Supplement to Volume 36, 2005.
Institute of Medicine. Emergency Medical Services At the Crossroads. National Academy of Science, June, 2006.
Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005;293:2609-2617.
Mello MM, Studdert DM, DesRoches CM, et al. Caring for patients in a malpractice crisis: physician satisfaction and quality of care. Health Affairs. 2004;23:42 -53
Mello MM, Kelly, CN. Effects of a professional liability crisis on residents’ practice decisions. Obstet Gynecol 2005;105:1287-1295
Personal communication, John Gibbons, MD, American College of Obstetrics and Gynecology.
Common Good Web site
Katz DA, Williams GC, Brown RL, et al. Emergency physicians’ fear of malpractice in evaluating patients with possible acute cardiac ischemia. Ann Emerg Med: 2005;46:525–33
www.acep.org/webportal/Newsroom/NR/general/2006/050206.htm
Mello, MM, Studdert DM, DesRoches CM, et al. . Effects of a malpractice crisis on specialist supply and patient access to care. Ann Surg. 2005;242(5):621-628.
Clinton HR, Obama B. Making patient safety the centerpiece of medical liability reform. New Engl J Med. 2006;354:2205-2208
costs.

Physicians exclude litigious patients from medical care, JAMA 2005.

Defensive Medicine Among High-Risk Specialist Physicians in a Volatile Malpractice Environment

Research shows that physicians exclude patients who are medically complex and litigious patients e.g. victims of medical errors from medical care.

David M. Studdert, LLB, ScD, MPH; Michelle M. Mello, JD, PhD, MPhil; William M. Sage, MD, JD; Catherine M. DesRoches, DrPH; Jordon Peugh, MA; Kinga Zapert, PhD; Troyen A. Brennan, MD, JD, MPH
JAMA (Journal of American Medical Association). 2005;293:2609-2617.

Context How often physicians alter their clinical behavior because of the threat of malpractice liability, termed defensive medicine, and the consequences of those changes, are central questions in the ongoing medical malpractice reform debate.

Objective To study the prevalence and characteristics of defensive medicine among physicians practicing in high-liability specialties during a period of substantial instability in the malpractice environment.
Design, Setting, and Participants Mail survey of physicians in 6 specialties at high risk of litigation (emergency medicine, general surgery, orthopedic surgery, neurosurgery, obstetrics/gynecology, and radiology) in Pennsylvania in May 2003.

Main Outcome Measures Number of physicians in each specialty reporting defensive medicine or changes in scope of practice and characteristics of defensive medicine (assurance and avoidance behavior).
Results A total of 824 physicians (65%) completed the survey. Nearly all (93%) reported practicing defensive medicine. "Assurance behavior" such as ordering tests, performing diagnostic procedures, and referring patients for consultation, was very common (92%). Among practitioners of defensive medicine who detailed their most recent defensive act, 43% reported using imaging technology in clinically unnecessary circumstances. Avoidance of procedures and patients that were perceived to elevate the probability of litigation was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years, including eliminating procedures prone to complications, such as trauma surgery, and avoiding patients who had complex medical problems or were perceived as litigious. Defensive practice correlated strongly with respondents’ lack of confidence in their liability insurance and perceived burden of insurance premiums.

Conclusion Defensive medicine is highly prevalent among physicians in Pennsylvania who pay the most for liability insurance, with potentially serious implications for cost, access, and both technical and interpersonal quality of care.

Author Affiliations: Department of Health Policy and Management, Harvard School of Public Health (Drs Studdert, Mello, DesRoches, and Brennan), Department of Medicine, Harvard Medical School (Dr Brennan), and Department of Medicine, Brigham and Women’s Hospital (Dr Brennan), Boston, Mass; Columbia Law School, New York, NY (Dr Sage); and Harris Interactive Inc, Rochester, NY (Mr Peugh and Dr Zapert).

WHO developments

The WHO acknowledges the necessity of:
political will, professional will and moral leadership to improve patient safety.
See: Eight Futures Forum WHO report on Governance of Patient Safety
Erpendorf, Austria 2005

The chance to die in an air crash is one in three million.
The change to be subject of a serious medical error is one in three hundred according to the WHO.
Various prestigious researchers conclude that one in six patients in hospitals are subjected to medical errors.
In more than 30 public researches on fatal medical errors within the National Health Service, the same causes were mentioned: isolation, inefficient systems and processes, poor communication and inadequate management/leadership.
The WHO report on the Futures Forum 2005 describes the following seven major sins in dealing with patients and their safety:
1. arrogance
2. denial
3. blaming others
4. attacking the messenger
5. to turn away/ not willing to see
6. inability to think about systems
7. passive learning

Co-operation and systematic evaluation
WHO-Europe concludes that in order to achieve solutions for more patient safety the following items are essential:
Political will, professional will, leadership, trustworthy data, patient empowerment.
Also a change of culture is necessary ,which implies more teamwork. As communication is vital for teamwork it will have a preventive influence. Last but not least systematic evaluation is necessary a.o. via the development of quality-indicators.

New Zealand: open and honest approach and no Fault Compensation system

Publications by Marie Bismark and Ron Paterson clarify the situation of patient safety in New-Zealand,give recommendations to approach victims of medical errors and their families in an open and honest way (see nr. 1) and describe and comment on the No Fault Compensation System in New-Zealand (see nr. 2).

1."Doing the right thing" after an adverse event.Bismark M, Paterson R. N Z Med. J. 2005 Jul 15;118 (1219):U1593
Citation from PMID: 16059413 [PubMed - indexed for MEDLINE]

Each year, the New Zealand Health and Disability Commissioner receives over a thousand letters of complaint from patients and their families, many of whom have suffered an adverse event. Often, the focus of their hurt and anger is not the injury itself, but the failure of a health professional to 'do the right thing' in the aftermath of the event. And in most cases, 'the right thing' requires no more, and no less, than living up to the ethical standards that we practise in everyday life: honesty, compassion, saying sorry, and a willingness to learn. Acknowledging that an adverse event has occurred can be hard, and facing up to an injured patient or bereaved family can be even harder. But the alternative scenario of silence and abandonment is worse: for patients, their families, and their health professionals.

2. No-fault compensation in New Zealand: harmonizing injury compensation, provider accountability, and patient safety. Bismark M, Paterson R. Health Aff (Millwood) 2006;25:278–83. [PubMed]
Citation from PMID: 16403765 [PubMed - indexed for MEDLINE]

In 1974 New Zealand jettisoned a tort-based system for compensating medical injuries in favor of a government-funded compensation system. Although the system retained some residual fault elements, it essentially barred medical malpractice litigation. Reforms in 2005 expanded eligibility for compensation to all "treatment injuries," creating a true no-fault compensation system. Blame-free compensation increases confidence, speeds resolution, and promotes safety, although corrections are still necessary.
Compared with a medical malpractice system, the New Zealand system offers more-timely compensation to a greater number of injured patients and more-effective processes for complaint resolution and provider accountability.
The New Zealand system for patients’ harmed by treatment puts litigation to shame
Fear of litigation is one of the biggest barriers to creating a culture of safety in health care. Finding the individual ‘at fault’ and proving negligence is at the core of the tort based legal process for compensating patients harmed by health care and this is entirely at odds with error reporting, open communication with patients, and the development of a collective responsibility for safety within health care.
But it doesn’t have to be this way, as Bismark and Paterson explain in a comprehensive description of the no-fault compensation system in New Zealand. Compensation can be delivered to patients quickly—in a system that expects claims to be settled within nine months, without pitching patient against doctor—as medical error has been re-framed as ‘treatment injuries’ and efficiently. In the New Zealand system 10% of the total budget is spent on administration compared with the 50–60% costs incurred in medical litigation in the USA—not to mention the massive difference in insurance premiums for those practising in New Zealand (NZ$1000 for all specialisms) with those in the USA.
The authors are aware that the system is not without its faults; compensation tends to be lower, favours those who are in employment, and has been criticised for not promoting accountability within health care. However, one cannot help conclude that the system is better for patients, the healthcare professionals treating them, and the tax payer who ultimately foots the bill of both New Zealand’s healthcare and compensation system. The only people who lose out, it would appear, are those in the legal profession. Could that be why a system with so many obvious benefits has failed to inspire the mass rejection of tort and malpractice by health systems striving to reduce expenditure beyond the antipodes?

The IEU-alliance appreciates the honest approach towards victims of medical errors as recommended in these articles by M. Bismark and R. Paterson and values the advantages of a No Fault Compensation System.

Veterans Health Administration adopts disclosure and remedial medical care for iatrogenic patients

October 2005 this department published VHA Directive 2005 – 049 entitled:
Disclosure of Adverse Events to Patients

Institutional disclosure of adverse events must include:
1. An apology including a complete explanation of the facts
2. An outline of treatment options.
3. Arrangements for a second opinion, additional monitoring, expediting clinical
consultations, bereavement support, or whatever might be appropriate depending on the adverse event.
4. Notification that the patient has the option of obtaining outside legal advice for further guidance.
5. After complete investigation of the facts, the patient or representative is to be given information about compensation under Title 38 United States Code (U.S.C.) Section 1151 and the Federal Tort Claims Act claims processes, including information about procedures available to request compensation and where and how to obtain assistance in filing forms. […]
6. If a patient or personal representative asks whether an investigation will be conducted and whether the patient or representative will be told of the investigation, the patient or representative is to be informed that only the results of an administrative board of investigation (AIB) may be released.

This VHA Directive expires October 31, 2010.

March 2006 the HARVARD HOSPITAL GROUP published its consensus report:
When Things Go Wrong: Responding To Adverse Events
Massachusetts Coalition for the Prevention of Medical Errors, March 2006
This group clearly chooses for open and honest disclosure as well as providing genuine follow-up diagnostics and remedial medical care to iatrogenic patients. See further under News.

Apparently and justly the VHA initiative served as an example. May all hospitals follow soon.

Denial and cover-up of medical errors by physicians acknowledged by Dutch medical association

See inaugural speech of top lawyer Dutch medical association, May 2006.

Johan Legemaate, lawyer of the Royal Dutch Medical Association
receives the Declaration of the IEU-Alliance. July 2006.

Patient Safety and Patient Rights, Inaugural speech Prof. J. Legemaate, Free University Amsterdam
The most important message of this inaugural speech by the top lawyer of the Royal Dutch Medical Association KNMG, who represents the interests of the physicians is the following:
Generally physicians do NOT inform the victims of medical errors nor their family about the fact that a medical error has occurred. The insurances of physicians and hospitals do not allow them, for fear of litigation. The medical error is “silenced to death” to the unknowing victims, unless e.g. the wrong leg has been amputated.

Legemaate pleads to delete these clauses from the insurance-policies* and pleads for open disclosure to the patient, to which the physicians in fact are already obliged on the basis of the Law on the Agreement of Medical Treatment ( WGBO).
Legemaate is however silent about the fact that as a consequence of the silence, victims of medical errors do not receive genuine follow-up diagnostics nor remedial medical care. If the physicians , who committed the error, would give adequate remedial medical care it would be the equivalent of informing the victim of the error, who would be able to start legal procedures.
The denial and silence on the medical error implies that the victim is sent away without adequate medical care. Unfortunately it is useless for the innocent victims of a medical error to consult another physician. Than it becomes clear that all physicians cover up, close ranks and send the victim away.

This is the important principle of the medical professional allegiance, which is a national and international phenomenon. It causes that not only the original physician who caused the error is silent, but it involves all other physicians who choose to be silent as well.
The overwhelming silence and cover-up leads to the horror position of a victim of a medical error: no access to adequate medical care! One can wonder whether victims of medical errors are blacklisted as potential litigants and whether those who have dared to challenge physicians and hospitals in court, have been blacklisted....

As Prof. Legemaate justly pleads for open disclosure to the victims, and has acknowledged in public that this has not been the standard approach, the following question arises:
What is the position of the present group of victims of medical errors, the iatrogenic patients?
Will he be willing to change his former advice of non-disclosure to a culture of change and convince his employer the Dutch Medical Physicians Association (KNMG), based on their ethical, legal and professional obligations to provide extra good medical care to those who have been harmed by a medical error?

Recently a prestigious group of Harvard hospitals has adopted this approach**, which was already outlined in a Directive to Veteran Affairs Hospitals by the Veteran Health Administration, october 2005, see above.

Is the Dutch practice part of an international code of silence, as experienced by thousands of patients and their families? Let us hope that the call for open disclosure by Prof. Legemaate will be followed by the development and implementations of international guidelines for full open disclosure and genuine follow up diagnostics and remedial medical care for damaged patients, worldwide.

*research has shown that MEDIRISK the largest Dutch insurer is owned by 74 Dutch hospitals.
This means that the silence about medical errors is imposed by the hospitals themselves!!
**Harvard Consensus When Things Go Wrong: Responding To Adverse Events, Massachusetts Coalition for the Prevention of Medical Errors, March 2006