Medical Malpractice and Patient safety: Exploring uncharted territory in Eastern Mediterranean Region

Transcription

1 Draft Report Medical Malpractice and Patient safety: Exploring uncharted territory in Eastern Mediterranean Region Thalia Arawi, Mondher Letaief, Sameen Siddiqi and Calvin WL Ho 1 Thalia Arawi, Founding Director, Salim El-Hoss Bioethics and Professionalism Program- American University of Beirut Faculty of Medicine and Medical Center. Sameen Siddiqi, World Health Organization, Regional Office for the Eastern Mediterranean. Mondher Letaief, World Health Organization, Regional Office for the Eastern Mediterranean. Calvin WL Ho, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore; Ethox Centre, Nuffield Department of Population Health, University of Oxford. 1 Calvin Ho is the corresponding author. On contribution: all four authors contributed to the drafting of the report, and an initial draft was prepared by Calvin Ho and Thalia Arawi. The initial concept outline was prepared by Calvin Ho, with comments from Thalia Arawi, Mondher Letaief and Sameen Siddiqi. Thalia Arawi, Mondher Letaief and Sameen Siddiqi contributed situational information on the Eastern Mediterranean region. We are thankful to Assil Araji, RA at the Salim El Hoss Bioethics and Professionalism Program at the American University of Beirut Faculty of Medicine and Medical Center, for assisting with this manuscript. 1

2 I. Introduction This draft Report is concerned with medical malpractice and its implications on patient safety, from a health systems point of view. It has two key purposes: (1) To review the current situation related to medical malpractice and patient safety; and (2) to broadly explore the existing regulatory mechanisms and challenges for medical malpractice. While the report has its focus on the Eastern Mediterranean Region (EMR), relevant experiences from beyond this region are discussed and considered. Essentially, medical malpractice has been construed in relation to regulation by law (principally litigation and professional conduct), monitoring and ethical (or professional) conduct. Financial control is an important regulatory mechanism that is not considered here, and may be included in future versions of the report. Medical malpractice is also broadly defined in this report as relating to medical errors. The types and causes of medical errors are varied (to be discussed further below), and could include deficiencies in foundational knowledge, mistakes in perception or judgement, attention deficiencies, imprecise or incomplete information, insufficient time spent with patients, medical uncertainties, and communication breakdown. These errors could be attributed to particular individuals especially healthcare providers and system failures. It should be emphasied that there is a wide range of approaches to identifying, measuring, monitoring and redressing medical errors that could or could potentially impact on patient safety, as well as the benchmarks used in assessment. Clearly, an important benchmark relates to quality of care and patient safety more broadly. While quality of care is discussed in this report to consider means of relating quality of care with medical errors and malpractices, it is not the focus of this present draft. There is no simple way to understand and address concerns with malpractice or medical errors more generally. There are also serious deficiencies in empirical evidence in 2

3 the literature on the incidence of medical errors, particularly in developing countries. With very limited exceptions, published data on medical errors that is available is largely drawn from healthcare institutions and regulatory bodies in developed countries. II. Medical Malpractice and Medical Error: Conceptual framework Medicine revolves around three main stakeholders: patients, healthcare providers and managers (Quershi, Neyaz, Khoja, Magzoub, Haycox & Walley, 2011). Different factors that affect each of these stakeholders can lead to unwanted results and dissatisfaction. Healthcare providers typically become legally accountable to patients when a therapeutic relationship is formed, such as through mutual consent between the patient and the healthcare provider, when the provider working for a healthcare management organization is assigned a patient, or when the provider is on-call in an emergency room where patients randomly arrive (Choctaw, 2008). Errors might occur at every stage of the medical process, starting with the provision of medical advice or diagnosis. In a broad sense, medical malpractice typically refers (but is not necessarily limited) to a provider s (and especially a doctor s) act of negligence while providing patient care which led to injury, even if the doctor did not intend to cause this harm. In most jurisdictions, negligence is determined with reference to sound standard of medical practices, which could be based on how doctors would reasonably act given the same circumstances (Choctaw, 2008). Medical negligence as medical malpractice is discussed later in this paper. Compromises to patient safety are not limited to medical malpractice and could arise with medical errors that may or may not have been caused by a negligent act or omission. Often, the focus is on medical errors that result in some form of harm, such as iatrogenic (or healthcare-caused) injury and healthcare associated (hospital-acquired) infections. On such occasions, an adverse event defined as an event that results in unintended harm to the 3

4 patient by an act of commission or omission rather than by the underlying disease or condition is said to have arisen (World Health Organization 2009). Given that an adverse event can result in prolonged hospital stay, permanent disability and even death, its causes and the responses elicited have been a primary concern of discussions on patient safety in the literature. Another large but unquantifiable concern relates to near misses, where errors have not resulted in harm to patients but could result in a future adverse outcome if not addressed. A near miss is defined as an event or situation that could have resulted in an adverse event but did not, either by chance or through timely intervention (World Health Organization 2009: 28). It has been suggested that up to half of adverse events could have been prevented if the patient had received ordinary standards of care appropriate for the time (World Health Organization 2009: 32). A number of published papers on retrospective reviews of patient medical records provide general support for this proposition, although the proportion of preventable adverse events may not be as high as 50% (see for example, Sari et al. 2007). Medical negligence referred to above could be viewed as a subset of preventable events, and the contributory act or omission constitutes a malpractice if there is a failure of care or skill, or a deliberate deviation from accepted practices (also referred to as a violation). Violations that are intended to cause harm to patients are relatively rare, but if commissioned, they could constitute a criminal offence and perpetrators could be subject to criminal prosecution, and independently from civil and/or professional sanctions. The relationship between near misses and different types of adverse events has been depicted in the following manner (Gray 2003: 2): 4

5 Figure 1: Venn diagram representing near misses and adverse events Two influential reports in the United States (Institute of Medicine 2000) and in the United Kingdom (Donaldson Report 2000) proposed that adverse events are largely unintentional and that improvements in patient safety are more likely to be secured by identifying and remedying system failures rather than personal failings. As we shall see below, public inquiries into medical scandals particularly in the United Kingdom have highlighted system failures, although malpractice litigation continues to emphasise individual (or institutional) failings. In the literature, there is considerable breadth in the classification of adverse events. An analysis into the causes of adverse events has contributed to much discussion on issues that are technical (e.g. sufficiency of incident reports and patient records), theoretical (e.g. human as opposed to system errors) and classificatory (e.g. multi-cause events). Other categories of adverse events in the literature include: Types of errors; Types of interventions; 5

6 Types of institution, healthcare unit and/or staff; Types of patients; Types of patient management; and Types of incidents (or harmful outcomes), such as pressure ulcers, hospital acquired infections, medication errors, patient falls, surgical errors, and blood safety issues. For instance, in an effort to inspect the relationship between malpractice risk and physician specialty in the United States, Jena et al. (2011) examined three elements pertaining to malpractice among 25 different specialties, these were: the proportion of physicians facing malpractice claims, the proportion of physicians faced with indemnity payments and the size of these payments. The data was obtained from a physician-owned professional liability insurer from 1991 to 2003 with a cumulative of 40,916 cases. The results showed that while 7.4% of physicians had a claim on yearly basis, 1.6% of which faced an indemnity payment. An interesting finding was that the number of claims faced was not significantly correlated with the number of indemnity payments made or with their size. Neurosurgeons faced an annual 19.1% of claims followed closely by thoracic-cardiovascular surgeons with 18.9% and general surgeons at 15.3%. The numbers drop to 5.2% of claims faced by physicians in family medicine, 3.1% for paediatricians and 2.6% in psychiatry. Gynaecology ranked highest in the proportion of indemnity payments made. As for the size of the payments, neurosurgery and neurology took the lead, followed by internal medicine, pulmonary medicine, general surgery, pathology and pediatrics. Jena et al. concluded that surgical specialists were at highrisk on an overall scale of medical malpractice claims followed by obstetrics and gynaecology. 6

7 Research findings on relative prevalence of malpractice claims are important for various reasons. To begin with, medical and allied health students should be aware of the prospect of facing a medical claim. Such knowledge could better prepare them in choice of specialty and also possibly in appropriately managing a near miss or adverse event when it should arise. In addition, it gives insight (particularly to regulators and institutional managers) on high-risk specialties that enables further study into the factors that contribute to a higher risk of facing malpractice claims. Risk management programmes should be, and often are, tailored to respond to the various risks faced by each specialty, as a uniform approach across all specialties is doomed to fail. On surgical errors, it was found that several surgical errors have led to litigation claims: when sorting these errors, several categories emerge which includes wrong-site surgery, wrong patient surgery, nerve damage, organ or tissue damage, incision error, foreign object in patient and cross-contamination (HG.org-Legal Resources). Some arise from gross negligence (such as carrying out a surgical intervention on the wrong patient), others can be fatal (such as cross contamination through the use of unsanitary surgical instruments). While investigating the reasons behind these errors, several factors emerge. These include: incompetence of the surgeon, lack of planning, communication failure in the operating room, fatigue, substance abuse and neglect. The wide range of approaches to identifying, measuring and monitoring patient safety, as well as the benchmarks used in assessment, shows that there is no simple way to understand and address concerns with malpractice or medical errors more generally. It follows that there is no simple or generic solution in redressing these concerns. There are also serious deficiencies in empirical evidence, as data on medical errors (and malpractice) is limited, as are large scale review of patient medical records. With very limited exceptions 7

8 (discussed in the section that follows), published data on medical errors that is available is largely drawn from healthcare institutions and regulatory bodies in developed countries. For this reason, discussion on regulatory mechanisms relates primarily to healthcare settings in these countries. III. Adverse events and medical malpractice in the Eastern Mediterranean Region (EMR) A. Adverse events From 2006 to 2008, a study was carried out in six EMR countries on a sample of designated hospitals from the region to estimate the magnitude and the scope of adverse events in hospital settings. The objective of the study was not to compare countries or regions. Instead, it was to obtain broad-based data on the magnitude of patient harm, the most frequent harmful incidents and their severity, when they had occurred, what their causes were, and their preventability and contributing factors. The results of the study provide data about the reality of these countries which cannot be ignored, and represent an urgent appeal to improve patient safety in developing and transitional countries more generally. On average, health care-related harmful incidents affected 8 in 100 of the patients. According to the study, four out of five incidents were preventable. This speaks to the substantial human and financial costs that could have been averted. Added to these costs are the erosion of trust among patients and the unnecessary surcharge of the healthcare system, which may lower the overall quality of care (See Table I; Source: Wilson RM et al. BMJ 2012). Table I: Frequency of adverse events (AEs), % of preventable adverse events, and % of admissions associated with adverse events that resulted in death in six EMR countries 8

9 AEs rate/100 % preventability % admissions resulting in Country admissions (CI 95%) (CI 95%) death Egypt 6.0 (4.7 to 7.3) 72.5 (62.8 to 82.2) 1.25 Jordan 2.5 (2.0 to 2.9) 83.3 (75.7 to 90.9) 0.61 Morocco 14.8 (12.6 to 17.0) 85.6 (79.9 to 91.3) 3.58 Sudan 8.2 (6.4 to 10.0) 55.1 (43.9 to 66.3) 0.75 Tunisia 8.3 (6.5 to 10.1) 85.7 (77.9 to 93.5) 1.29 Yemen 18.4 (16.5 to 20.3) 92.8 (89.9 to 95.7) 4.28 Total The rate of adverse events by length of stay is indicated as average for index admission in sampled records, per hospital. Rates increases with length of stay, starting at 4% and increasing to 25% for stays of 30 days. Length of stay is shown as average for index admission in sample record per hospital (See Figure 2; Source: Wilson R M et al. BMJ 2012; 344:bmj.e832). 9

10 Figure 2: Rate of adverse events by length of stay, indicated as average for index admission in sampled records, per hospital It is also known which procedures and areas of activity are most likely to lead to adverse outcomes: 34% of the observed incidents resulted from therapeutic errors. Others came from diagnostic errors (19%) or surgical mistakes (18%), and were related to obstetrics (9%), neonatal procedures (8%) and non-surgical procedures (5%), or were caused by drug-related incidents (4%), fractures (2%), anaesthesia (0.5%) and falls (0.5%) (See Figure 3; Source: Wilson R M et al. BMJ 2012). Figure 3: Type of error related to occurrence of adverse event shown as percentage of 890 adverse events with codes for this classification A prospective study on the incidence and contributing factors of adverse events in three general surgery departments from three tertiary hospitals shows that the overall incidence rate of adverse events was 18.1%, the most frequent surgical adverse events were operative adverse events and hospital acquired infections at a rate of 34.9% and 30.3% respectively. Patients over 65 years were more exposed to adverse events than those under age 65 years (cumulative incidence 21.9% vs. 14.3%; identified intrinsic risk factors, extrinsic risk factors, 10

11 length of stay > 7 days (p<0.01) and duration of surgery > 60 min (p<0.01)). The consequences were prolonged hospital stay (at 90%), permanent disability (at 6%) and death (at 4%). A majority (62%) of the identified adverse events were considered to be moderately to highly preventable (See Table II). Table II: Adverse events and patient characteristics Patient characteristics Relative Risk CI 95% Elderly ( 65 years) Male Gender Intrinsic risk factors Extrinsic risk factors ASA score (> II) Duration of surgery (> min) Unplanned admission LOS (> 7 days) None of the seven hospitals assessed achieved the 20 critical patient safety standards that are necessary to enroll a hospital in the Patient Safety Friendly Hospital Initiative (World Health Organization 2008). The shortcomings were consistently distributed across all domains, suggesting that any improvement initiative would need to be comprehensive and should address all critical areas. 11

12 Figure 4: Achievement of critical standards across domains of patient safety (Source: Siddiqi S et al. 2012) B. Medical Malpractice With limited exceptions, systematic study on medical malpractice in the EMR region is generally lacking. In an attempt to analyse the medico-legal liabilities in anaesthetic practice in Saudi Arabia, a study was conducted on collected data of 1765 cases referred to the Medico-Legal Committee in the Ministry of Health in Riyadh, Saudi Arabia between 1999 and 2003 (Samarkandi 2006). The Saudi community has experienced an increase in the number of medical cases filed against professionals or organizations. This has been attributed to an increase in the patient population, as well as in the awareness of individuals of their legal rights. Anaesthesia is considered as a high risk specialty because the induced anaesthetized state might result in airway obstruction, pulmonary aspiration or trauma. About 3.8% of the total number of claims where anaesthesia-related of which 9.1% ended with legal action against anesthesiologist. Some of these cases resulted in dental loss during intubation, death outcome from severe bleeding, failed intubation and inadequate post-operative care. 12

13 Other studies have shown that cardio-respiratory arrest and cerebral damage resulting from hypoxemia are leading causes of adverse effects or even death in anaesthesia-related malpractice cases. These adverse effects can be due to oxygen shortage or equipment malfunction, neuroaxial deficits resulting from regional anaesthesia is another cause for adverse events. After examining the filed cases, Samarkandi recommends a set of precautions that would protect physicians from anaesthesia-related legal consequences. These are: consult with physicians of different specialties so that different aspects of the patient s case, estimate the risks of the case and discuss them with both the surgeon and patient (as an anaesthesiologist), discuss the risks of anaesthesia with the patient and the course of action that will be followed during the surgery, document all aspects of the case, follow-up with patients after surgeries so that adverse events can be identified early on, update knowledge on the latest developments in the field of anaesthesia and finally, in case of litigation, go over every detail of the case and research similar cases. In 2013, around 200 malpractice cases were registered in Jeddah alone, ranking the highest region with medical errors in Saudi Arabia (Al Hamid 2014). The errors have been mostly identified pertaining to operations and anaesthetics. This has prompted Jeddah Health Affairs to implement a new project in an effort to control the problem which mainly requires hospitals to install a Central Monitor in their operation rooms. The monitor will videorecord the happenings of the operation rooms and thus can be used to evaluate cases of malpractice. The system has already been implemented in a set of hospitals and will continue to be implemented in all Jeddah hospitals. The Dubai health authority revealed that in 2013, more than 500 medical complaints were filed against doctors operating in private, public and clinical settings (Bell 2014). This staggering number calls for a re-evaluation of health management and an inspection of its 13

14 systems of governance. In Dubai, a victim of medical malpractice can choose from three courses of action, which are: filing a civil case, filing a complaint at the Dubai Police or Public Prosecutor which has the potential to result in a criminal case or filing a complaint at the Dubai Health Authority. It is worth mentioning that unlike many other countries, malpractice that results in disability or death is regarded as a crime in the United Arab Emirates. Although such a legal sanction is intended to hold physicians responsible for their acts, it discourages doctors from admitting to mistakes. In Abu Dhabi, for instance, licensed practitioners are required by law to report not only mistakes but also near misses. Moreover, anonymity is not allowed (Bell, 2014). Such legal requirements have been criticised as setting unrealistic standards that are impossible to meet, since errors are inevitable. They also result in distrust between doctors and patient, as perhaps reflected in the high number of complaints registered against doctors in these systems. IV. Key Components of Regulatory Mechanisms for addressing Medical Malpractice Regulation of healthcare providers is necessary as the provision of healthcare services is not without risk (McDonald 2010). In many countries, regulatory approaches have conventionally focused on individuals (essentially through litigation) or control through professional bodies, such as government-sanctioned self-regulation (Mello, Kelly and Brennan 2005). Perceptions of risk are generally accepted in the literature as under the influence of trust, which in turn influences perceptions as to the acceptability of policies. An associationist model suggests that trust influences and is influenced by perceptions of policy acceptability, and this in turn influences and is influenced by risk (Poortinga and Pidgeon 2005). There is empirical evidence to support this model, as well as other interpretations that draw a more direct association between risk and trust. These approaches are themselves not exhaustive, and there is growing emphasis on other values, 14

15 such as accountability. In her comparative analysis of public inquiries and quasi-public inquiry (e.g. parliamentary inquiries and coronial inquests) into scandals concerning the health profession in the UK and Canada, Fiona McDonald (2012) explains policy acceptability in terms of the interrelationship among four key components: trust-risk-accountabilitycontrol. In the context of this study, scandals relate to medical events or actions that are regarded as ethically or legally unacceptable and have caused general public outrage. Key components of regulatory mechanisms: From the standpoint of policy analysis at least, there are four essential characteristics of these key components: Trust, Risk, accountability and Control. These are explained in the following manner: Trust component: o Duration of scandal The revelation through 14 public inquiries of many problems that persisted for a long time in Britain showed a failure in the regulatory system such that trust was seriously undermined. In contrast, two of the three Canadian scandals examined by public inquiries were of a limited duration (of less than a year) before definitive action was taken, and consequently less detrimental to public trust in the regulatory framework. o Narrative of scandal Narratives can influence trust because they graphically illustrate reasons why the public should mistrust certain actors in the health system. Scandals may illustrate governance failures by individual health professionals or professional bodies and/or by the regulators. In Britain, regulatory reforms introduced to de-emphasise professional self-regulation and to strengthen regulatory mechanisms outside of the medical profession could be attributed to the many cases that illustrated the reluctance of the 15

16 profession to self-regulate (without external compulsion or oversight), even when the conduct or performance of colleagues placed patients at risk. Risk component: o Frequency The frequency of public scandals and public inquiries convened in response to these scandals. It was found that between 1980 and 2005, 14 public inquiries were commissioned within Britain s National Health Service (NHS), raising issues that touched on professional regulation. In contrast, there were only three scandals relating to health professionals in Canada during that period. The relative infrequency of these events in Canada suggests that there was unlikely to be any aggregate effect on perceptions about the level of risk associated with the way in which health professionals were regulated, whereas there was more likely an aggregate effect in Britain. o Scale of scandal The number of victims generally affects the impact upon the public. For instance, in the Shipman Inquiry of 2002, Dr Harold Shipman was suspected of killing around 245 of his patients. Aggregation in this context similarly contributed to amplification of perceived risks. o Location of risk Risks that were more likely to be regarded as not isolated or restricted to one bad hospital or bad doctor could accentuate perceptions of adverse risk attributable to the system in general. Where a health system is fragmented and composed of different regulatory frameworks (such as in Canada), it would be more difficult to regard malpractices or scandals that occurred in one jurisdiction (or state) to be as impactful in another 16

17 jurisdiction (or state), even if they are both part of one national health system. o Narrative of scandals As indicated above, narratives of scandals enable the public to identify and empathise with the individuals caught up in the scandals, thereby raising the impact of the level and degree of risks perceived. The aggregation effect also served to amplify the inability of existing regulatory structures in dealing with the risks posed to patients. For instance, the Royal Liverpool Children s Hospital Inquiry (2001) revealed that the hospital retained 2,080 children s hearts, other organs from more than 800 children, and 400 foetuses, all without the knowledge and consent of parents. The scale of this scandal, together with other scandals reported in public inquiries, highlighted the inadequacies of professional self-regulation in Britain during that period. o Responses to scandals Responses to the risk event could define the risk itself. Accountability component: Mechanisms of accountability could be retrospective in attributing responsibilities for certain wrongs or malpractices. But they can also be prospective in specifying the obligations of actors and in orientating them towards compliance. It has been argued that it is not the publication of standards but the enforcement of the standards that matters to whether trust is well placed (Sorrell 2007). On this rationale, accountability is absent if there is no real mechanism through which the public could turn to hold healthcare professionals or professional regulatory bodies accountable for failings or malpractices. 17

18 Control component: Increased perception of risks, together with a mistrust of regulators and perceptions that current accountability mechanisms are ineffective, could result in increasing demands for greater control. Public inquiries during periods of crisis, change, growth or adjustment have been seen as a means of determining if self-regulation is effective or not. In view of the significant and lasting impact that they can have on perceptions of risks, public inquiries tend to be reserved to serious violations of public interests or issues of serious public concerns. V. Responsive Regulation and Regulatory Plurality A more commonplace understanding of regulation is encapsulated in the responsive regulation model, which presents regulatory actions as a means of steering the flow of events, rather than strictly limited to the enforcement of rules and regulations. By this approach, regulators should be responsive to context, culture and behaviour of those being regulated, and soft regulation should always be used first, on the understanding that noncompliance will lead to an escalation towards hard regulation (typically more restrictive and with harsher sanctions) (Braithwaite 2008). Judith Healy (2012: 206) presents the responsive regulation model in the following graphical manner: 18

19 Figure 5: Pyramid of selected regulatory mechanisms While the two most common regulatory strategies in the health sector remain voluntary regulation by individual themselves and self-regulation by healthcare professions, there has been a regulatory shift upwards towards stronger intervention by the state. Stronger regulation involves strategies of co-regulation with the professions (such as accreditation of training programmes), meta-regulation by the state or its agents in ensuring that the professions better regulate themselves (such as public reporting on performance indicators), and enforcement strategies (command and control) at the apex of the pyramid (such as legislation and court orders). The pluralisation of professional regulation has been attributed to an international regulatory trend from the 1980s that shifted mechanisms designed to protect professionals towards those that protect patients (Walshe 2009). A shift to pluralist regulation led to the involvement of multiple regulatory actors and multiple regulatory strategies, so that certain concerns are no longer exclusively the mandate of professional decision-making. In Britain and Australia, for instance, important aspects like access to the profession, good clinical practice and means of ensuring patient safety are no 19

20 longer exclusively controlled by a professional (medical) body. The following table illustrates the shift in regulatory mechanisms in Australia (Healy 2012: 210): Table III: Regulatory mechanisms protecting professionals vs. patients This shift in emphasis is expected to have significant impact on six interest groups, namely: Policy makers, that include politicians, senior health department administrators, purchasers and funders, and regulators; Providers, which include health service organizations and employers, such as hospital directors; Professions, including professional associations, colleges and boards; Professionals; Public, or the general population; and Patients. In relation to access to the profession in many countries, decisions on who will be admitted to the profession are no longer within the discretion of the profession. Instead, the state is involved in a variety of ways. Similarly, good practice initiatives directed at producing better professionals to achieve better health outcomes for patients, as well as mechanisms to ensure patient safety would involve a rubric of many regulatory mechanisms. The table 20