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

21 below sets out the expected impact for each of the interest groups set out above (Healy 2012: 212): Table IV: Benefits of regulatory mechanisms to six groups Focusing on initiatives directed at enhancing patient safety, the international consensus is that good governance requires policymakers to put in place some form of adverse event reporting. Internal reports provide an important internal quality improvement opportunity, and a lot of effort has gone into training staff in analyzing adverse events. However, adverse event reporting is also more problematic relative to other forms of performance reporting, as providers and professionals fear that transparency could incur punishment and lead to legal liability. Consequently, it is often framed as a confidential quality assurance activity rather than as a transparent measure of performance. Reporting in many countries is usually 21

22 voluntary and anonymous, and if published, data tends to be used internally for quality improvement purposes or published in aggregate and de-identified form. Countries also differ on whether they have national or regional systems for reporting of adverse events. In addition, different systems tend to adopt different incident classifications that limit comparability. In the light of these limitations, there is a lack of strong research evidence on whether adverse event reporting produces safer patient care, in spite of the effort and cost involved in setting up and maintaining reporting systems. With the exception of certain Canadian provinces where legislation has been passed to require patients and their families to be told of the occurrence of an adverse event, many countries do not legally mandate such disclosures although there may be provisions to ensure that an apology will not be regarded in court as an admission of liability (Levinson and Gallagher 2007). While some countries have endorsed a national open disclosure standard, it is unclear how this can be implemented in practice. Understandably, individual clinicians find such disclosures to be personally very difficult, particularly with the prospect of legal liability or professional (or regulatory) sanctions. Regulation by litigation is generally regarded as an important mechanism for improving patient safety. Malpractice lawsuits are intended to minimise unsafe practices, compensate for the patient s injury and ensure justice (Studdert, Mello & Brennan, 2004). From a policy standpoint, it serves as a societal integrity mechanism in that it requires a person (i.e. a clinician) to account for his or her action, or lack thereof. Litigation is typically regarded as a last resort for a patient who has suffered harm due to medical negligence. However, there are serious limitations to litigation as a regulatory mechanism for ensuring patient safety, 22

23 particularly in a prospective sense. First, it could lead to high rates of litigation without producing better patient safety outcomes. Some countries have responded to this concern by reducing the scope of claims that aggrieved patients could make and the size of awards that they could obtain. Second, fear of litigation could undermine learning from medical errors, especially since the tort law system is adversarial. Third, most cases are settled out of court through confidential agreements and hence do not prevent learning opportunities for the profession as a whole. VI. Regulation by Litigation In common law countries (including Australia, Canada, India, Malaysia, New Zealand, Singapore, United States, and United Kingdom), patients who suffered medical injuries can bring a legal claim under the tort of medical negligence, for instance, for compensation. Medical negligence is a specialised area of law concerned with standard of medical conduct that is considered acceptable in law. It imposes a duty on doctors to take reasonable care to avoid injury to those under their care. A duty of care generally exists in law on a doctor looking after her patient, the latter being someone who has relied on the former s expertise. For doctors in general, the law in some common law countries (like Singapore) has primarily deferred to professional medical knowledge in the determination of an appropriate standard of care relating to medical diagnosis and advice, including obtaining consent and treatment (or what is commonly known as the Bolam Test ). By this standard (also described as the professional practice standard), a doctor is not guilty of negligence if he or she has acted in accordance with a practice accepted as proper and responsible by a responsible body of medical practitioners skilled in that particular art, subject to the test of logical reasoning. So a doctor would not be legally negligent for a diagnosis, advice or treatment if it is supported by a respectable body of medical opinion, so long that opinion can be logically defended. For 23

24 instance, a doctor could decide as a matter of medical judgement whether it would be appropriate to disclose a particular risk to his or her patient based on such a body of knowledge and usual practice. A doctor could be negligent for failing to disclose a particular risk that was substantial and where there was no cogent clinical reason for non-disclosure. In the following excerpt from Principles of Biomedical Ethics (2009: ), the essential characteristics of the professional practice standard in relation to the disclosure of material risks have been described by James Childress and Tom Beauchamp, alongside some challenges to its application: The professional practice standard. The first standard [of disclosure] holds that a professional community s customary practices determine adequate disclosure. That is, professional custom establishes the amount and kinds of information to be disclosed. Disclosure, like treatment, is a responsibility of physicians because of their professional expertise and commitment to the patient s welfare. As a result, only expert testimony from members of this profession could count as evidence that a physician violated a patient s right to information. Several difficulties affect this standard, which some call a reasonable doctor standard. First, it is uncertain in many situations whether a customary standard exists for the communication of information in medicine. Second, if custom alone were conclusive, pervasive negligence could be perpetuated with impunity. The majority of professionals could offer the same inadequate level of information or have total discretion to determine the scope of disclosure. Third, it is questionable whether many physicians have developed the skills to determine the information that serves their patients best interests. Empirical studies cast doubt on this claim. The weighing 24

25 of risks in the context of a person s subjective beliefs, fears, and hopes is not an expert skill, and information provided to patients and subjects sometimes needs to be freed from the entrenched values and goals of medical professionals. Finally, and perhaps most compellingly, the professional practice standard subverts the right of autonomous choice. Professional standards in medicine are fashioned for medical judgments, but decisions for or against medical care, which are nonmedical decisions, are rightly the province of the patient. Two other standards have been described by James Childress and Tom Beauchamp: the reasonable person standard and the subjective standard : The reasonable person standard. Although many legal jurisdictions rely on the traditional professional practice standard, a reasonable person standard has gained acceptance in over half of the states in the United States. According to this standard, the information to be disclosed should be determined by reference to a hypothetical reasonable person. Whether information is pertinent or material is to be measured by the significance a reasonable person would attached to it in deciding whether to undergo a procedure. Hence, the authoritative determination of informational needs shifts from the physician to the patient, and physicians may be found guilty of negligent disclosures even if their behavior conforms to recognized professional practice. The subjective standard. Finally, the subjective model judges adequacy of information by reference to the specific informational needs of the individual person, rather than by the hypothetical reasonable person. The subjective standard 25

26 requires the physician to disclose the information a particular patient needs to know, if it is reasonable to expect the physician to know that patient s informational needs. [But] exclusive reliance on a subjective standard does not suffice for either law or ethics because patients often do not know what information is relevant for their deliberations, and we cannot reasonably expect a doctor to do an exhaustive background and character analysis of each patient to determine the relevant information. While it is generally recognised in common law countries that the ability for an individual to bring a legal claim in medical malpractice is a critical feature in empowering patients to safeguard their legal entitlements and to meet just ends where compensation is due, most (if not all) of these jurisdictions do not support an excessively robust medical malpractice approach in healthcare governance. Some common law jurisdictions have augmented professional regulation and limited legal claims through medical malpractice lawsuits (such as in Australia, Singapore and the United States), others have moved progressively towards a no-fault system (such as New Zealand). A similar trend is observed among other noncommon law OECD countries, although regulatory approaches are relatively varied (OECD, 2006). Broadly speaking, systemic changes continue to be made to enhance patient safety through incentivising disclosure and learning from adverse events and near misses, with less focus on fault, but without compromising on fair and appropriate treatment of the patients (and their families, broadly construed) involved. In Lebanon, the law on medical ethics encompasses a set of articles on doctors conduct that are registered in the syndicate of Lebanese doctors. The law states that the role of doctors in 26

27 society is to promote the physical and psychological well-being of the human being, alleviate pain and suffering, and improve the quality of public health. Articles 3 and 4 of the Lebanese law emphasise the doctor s duty to treat all patients without prejudice and to respect their wishes. However, Article 7 on confidentiality states that although the doctor-patient confidentiality is imperative, therapeutic privilege allows the doctor to conceal information from the patient if the doctor believes such information would lead to adverse results, such as suicide. Although this privilege exists to protect patients in extreme cases from emotional and psychological harm, it is a subjective assessment. The doctor relies on his/her judgement on deciding when to use this privilege. Additionally, although deteriorating health brings an emotional and psychological toll, it is usually not a good reason to conceal information from the patient. Ageing, serious health risks and death are facts which every rational human being knows are inevitable. Most of us devise wills and have plans on what should be done at such instances. One can argue that concealing important information from patients prevents them from carrying on these plans before deterioration in health or death and from exercising autonomy choice. According to Erik Erikson s stages of psychological development, during our lifetime, we go through a series of stages where we either triumph or fail. These stages begin with our birth and end with our death. The final stage being ego versus despair, where we contemplate in retrospection on our lives, and it can be initiated with feelings of approaching death (Nevid, 2011). Accordingly, concealing important information concerning the patient s health robs 27

28 him/her the right to grief, the right to say final words and the right to come to terms with reality. Under the same Article, the law states that in cases of sexual harassment or rape, the doctor is obliged to report the incident upon written consent by the victim. Although this clause intends to respect the wishes of the patient, it does not serve to protect the patient from further attacks. Rape and harassment victims commonly decline to report such attacks for several reasons. These include fear, family pressure and social stigma. Reporting such acts should be completely mandatory yet confidential. The role of doctors is not limited to physical care; it also takes account of several relevant considerations, such as the psychological, social, spiritual, financial and emotional well-being of patients. The rise of malpractice lawsuits in countries such as the United States have led some to question the goals achieved by these lawsuits and how they might affect the development of the medical practice. At an institutional level, the field of risk management emerged in the mid-1970s as a response to the increasing costs of medical malpractice suits on insurance companies. The field continues to develop as new approaches are investigated and further improvements are made to the hospital environments. In essence, risk management is the field of identifying and assessing risks in advance, with the main goal of minimising adverse outcomes. It also aims to protect the assets of hospitals and to reduce financial losses, promote a positive image of the medical facility and build a relationship of trust between the staff and patients. Risk management is an on-going process of continuously identifying risks and exploring the ultimate methods of elimination. According to Singh and Ghatala (2011), a risk manager is expected to complete several tasks to fulfill his/her duties, which include: 28

29 identifying potential risks that could lead to various kinds of losses, assessing those risks by monitoring them while comparing them with the situation in other hospitals, eliminating dangerous procedures and checking equipment performance, transferring liability by having hold harmless agreements with drugs and equipment manufacturers and obtaining good insurance coverage. Risk managers are people that possess strong critical thinking skills, are able to sense potential risks in advance and devise efficient plans accordingly. In addition, the patient-safety movement which was initiated in around 1996 acknowledges the need to minimise medical errors and to ensure patient safety (Hendee, 2004). However, the movement recognises that minimising errors starts with providing physicians a safe environment where identifying and reporting errors are encouraged as a tool of learning and improving healthcare (Studdert, Mello and Brennan, 2004). Moreover, the movement considers that patient safety can be achieved when healthcare providers, as well as patients, collaborate to ensure utmost safety and minimise erroneous conduct. These various initiatives work towards the same ends, and are grounded in the recognition that the ethical and professional foundations of the medical practice should be secured (Hendee, 2004). VII. Ethical / Professional Governance Ethical and professional foundations are broadly recognised as a critical component to ensuring patient safety, although there is no clear consensus over how they should be measured, monitored or inculcated through a medical curriculum. Medical malpractices have been traced to different failings in ethical and/or professional attributes. These include: 1. Communication Practices Medical malpractices are the result of many factors combined. One of the key constituents that lead to medical malpractice and jeopardise patient safety is patient-physician 29

30 miscommunication. Indeed, as found by the Joint Commission International, communication is the greatest root causes of sentinel events. Communication however is not only verbal, but also extends to nonverbal and written forms. Ralph Nichols, a researcher in the field of listening, identifies a set of bad listening habits that can lead to patient-physician miscommunication. Among these are: failure to pay attention as the subject may seem uninteresting, losing interest in lengthy explanations and becoming distracted (Gorney, 2005). Effective patient-physician communication is critical in preventing medical errors and thus should be properly emphasised in healthcare environments and in the training and education of future physicians. This involves formal and informal training, taking into account challenges posed by the hidden curricula. Several practices can enhance the physician s communication skills. These include providing reflective feedback (which refers to asking the patients questions and providing visual cues), exerting effort to focus on the patient s complaints and exhibiting body language cues of attentiveness and interest. On the other hand, an appropriate form of verbal communication is another vital factor. A physician should exhibit a reassuring tone of voice and avoid the use of medical jargon, bearing in mind the varying intellectual and educational levels of patients. The physician s body language holds an equivalent value of significance from facial expressions to eye contact and body position (Gorney, 2005). 2. Failure to Maintain Proper Documentation Failing to properly document the patient s case can lead to avoidable errors. Documenting all aspects of the patient s case can improve the quality of healthcare provided as well as protect the doctor from allegations of negligence or misconduct. Several documentation formats are available; the S.O.A.P (or an abbreviation for Subjective-Objective-Assessment- Plan) format of documentation is especially popular among physicians (Choctaw, 2008). 30

31 3. Prescription Errors Physicians should always take the time to present a prescription with a legible handwriting; this simple yet vital rule can prevent miscommunication and its potentially damaging consequences. Additionally, prescriptions should be thorough, complete and correctly spelled out (Choctaw, 2008). 4. Behaviour inappropriate to Patient Care With reference to the standards set out by the American Medical Association, inappropriate behaviour could relate to a style of interaction between a physician, patients, family members, hospital personnel or others, that interferes with patient care. Aberrant behaviour could also be manifested in personal interaction which interferes with patient care or could reasonably be expected to interfere in the process of delivering quality care (Choctaw, 2008). 5. Prejudice From a psychological perspective, prejudice as well as patient compliance can lead to medical malpractice. Although physicians aspire for utmost objectivity, they bring their cultural norms, values, beliefs and stereotypes into their clinics, and these can sometimes affect their judgment. Additionally, the widely held notion of doctors know best discourages the patient from questioning the physician s judgement and recommendation (Qureshi et al., 2011). In Lebanon, for instance, socioeconomic and political constructs affect the practice of medicine in times of conflict and turmoil. Lebanon s social and religious divisions have lingered into the field of medicine, resulting at times in the marginalisation of patients as human beings. Prejudices and stereotypical beliefs, mostly from religious and 31

32 social suppositions, can play a role in blurring a physician s correct judgments (Abou-Mrad & Tarabey, 2012). 6. Conflicts of Interest Ordering unnecessary tests, postponing discharge from hospitalisation or even preferring certain medication over another for financial gain could all be viewed as inappropriate professional behaviour and malpractice. This is especially true in regions that are financially disadvantaged, such as Lebanon (Abou-Mrad & Tarabey, 2012). The medical profession is a moral enterprise and medicine is a humane profession that is both art as well as science. Thus although physicians are expected to make a living out of their profession, the ethical aspects of their profession limit how financial gains are achieved. Famously, the Hippocratic Oath that unites physicians all over the world mandate that the interests and well-being of the patient should always come first. VIII. Quality of Care Improving quality of care and patient safety is being prioritised by countries of the Eastern Mediterranean Region (EMR). According to the World Health Organization, 14 out of 22 countries have chosen patient safety as a priority for the operational planning of the With regards to their health status, countries of the EMR can be divided into three distinct categories: their population health outcomes, health system performance and level of health expenditure. The first group comprises of countries where socioeconomic and health status has remarkably developed over the past decade. This group is comprised of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates. The second group is 32

33 middle-income countries with a solid public health infrastructure but suffer from resource constraints. This group includes: Egypt, Islamic Republic of Iran, Iraq, Jordan, Lebanon, Libya, Morocco, occupied Palestinian territory, Syria and Tunisia. Last but not least, the third group of countries comprises those whose population health outcomes suffer due to political instability, lack of resources as well as other complex challenges. Afghanistan, Djibouti, Pakistan, Somalia, Sudan and Yemen belong to this group. There is a serious commitment to improve and develop the quality of healthcare in the first group countries. The governments of these countries are implementing regulations to promote better performance in healthcare facilities. As for the status of primary healthcare, some countries excel in certain areas (or healthcare services) more than others. For instance, immunization, maternal health and control for epidemic diseases are services of high quality in a number of countries, but chronic disease management and interpersonal care are not as equally impressive. One of the factors that impede the improvement of the quality of primary healthcare is a financial one; in some places, health insurance is not mandatory such as in Dubai. Lack of financial resources might prevent patients from seeking the care they need. Other factors include malfunctions in governance systems of hospitals, as well as delivering timely but inefficient care. As for the second group of countries, although healthcare is a priority in public policy, they face several challenges, such as the inefficient delivery of services and inadequate use of resources. Governments of these countries, however, are especially interested in improving their primary healthcare facilities. Rural areas are getting increased attention as minimum facilities are becoming available everywhere. In some countries, such as Lebanon, the private sector as well as non-government organizations are contributing to the development of the health sector and the services provided. In the third group of countries, access to 33

34 quality healthcare is not equally available as social class determines the kind of care received. Inexperienced and poorly skilled physicians are another barrier to quality care in these countries. The governments, however, are partnering with international organizations to improve the standards of healthcare, such as the collaboration between the government of Yemen and World Health Organization (WHO) to improve services over the course of five years. The Universal Health Coverage initiative (or UHC) is based upon the availability of good quality healthcare to all people independent of their financial status. There are three main elements to UHC, these are: population, services and cost. It also encompasses services pertaining to health promotion, disease prevention, rehabilitation and palliative care. These stem from a prerequisite of equal access to medicine and needed technology to achieve its goals. The evaluation of healthcare facilities is based upon three criteria, which are: licensure, accreditation and certification by either government authorities or internationally recognised organizations. However, making the right priorities depends on a complex set of factors. For example, if there is insufficient financing, healthcare facilities should invest in improving the quality of care rather than obtaining accreditation. The notion of clinical governance refers to the ability to thoroughly understand and learn to develop the fundamental components of quality care using a no-blame, questioning, learning culture, excellent leadership, and an established partnership between staff and patients. However, this approach has proved too broad and intangible to implement. Clinical governance is more or less an approach to medicine that observes the field as non-static and in continuous development; a learning process with a sole goal of providing the ultimate healthcare possible for all. The WHO has developed several initiatives in order to develop and improve the quality of healthcare worldwide; these initiatives are also available in the 34

35 EMR region. For example, the Clean Care is Safer Care global challenge has been developed by WHO to ensure that health facilities are meeting the required international hygiene standards that protect patients from healthcare associated infections. It especially emphasises hand hygiene as an easy yet essential component in preventing the spread of infections. So far, only 1,317 facilities from the EMR region have joined the initiative, a small number compared to other regions. The Safe Surgery Saves Lives challenge is another initiative developed to recommend a set of standards that ensure safe surgeries at an international level. Other interventions at the global level include the development of a Patient safety Multiprofessional curriculum guide, the patient safety friendly hospital initiative and the patient safety toolkit for assessment and improvement of patient safety practices. IX. Interim Conclusion As indicated in the IOM report, patients who end up with long stay at the hospital or with infirmity as a result of errors suffer physical as well as psychological discomfort. Members of the healthcare team involved in the case suffer a loss of morale and weariness at not being able to provide the best possible care for the patient. In sum, society suffers the negative social costs of reduced motivation and trust within its healthcare system and lower quality of care and patient safety standards overall. However, studies have shown that with adequate leadership, attention, and resources, improvements can be made. Disclosing errors to patients is critical, as any decision to deny information about mistakes necessitates ethical justification. There is growing evidence that full disclosure with apology and compensation noticeably reduces the number of lawsuits and the total expenditure in malpractice appeals. In addition, full, frank and timely disclosure 35

36 of near misses and adverse events are pre-requisites to an effective culture of learning from mistakes. Hence, suitable systems of reporting and tracking should be developed to promote this. These endeavours should complement continuing ethical and professional emphasis on respect for patients and promoting their welfare and overall wellbeing. As James Reason explains, error is inevitable. Although we cannot change the human condition, we can change the conditions under which people work. Patients need to be educated. They need to understand and to be appeased. Physicians need to listen to them to understand their cultural backgrounds, level of education, fears and worries in order to address them. Checks and balances need to be installed, good communication should be taught and encouraged as it is vital in minimizing errors. As Leap explains, full disclosure is an ethical imperative, and this report has set out a number of considerations that pertain to health systems and workforce governance. Select Bibliography Abou-Mrad, F, Tarabey, L Cultural Diversity and Quality Care in Lebanon. J Clinic Res Bioeth 3:140. Retrieved from: Al Hamid, N. (2014). Jeddah tops in medical malpractices. Arab news. Retrieved from: Bell, J. (2014). More than 500 medical complaints made in Dubai last year. The National/UAE. Retrieved from: medical-complaints-made-in-dubai-last-year Braithwaite, J Regulatory Capitalism: How it Works, Ideas for Making it Better. Cheltenham. Northampton, MA: Edward Elgar. 36

37 Childress, J and Beauchamp, T Principles of Biomedical Ethics. Oxford: Oxford University Press. Choctaw, W Avoiding medical malpractice: A physician s guide to the law. Springer New York. Doi: / Gorney, M Medical malpractice: a physician s sourcebook. Anderson, R (ed). Humana Press. Gray, A Adverse Events and the National Health Services: An Economic Perspective A Report to the National Patient Safety Agency. London: National Patient Safety Agency. Healy, J Improving Health Care Safety and Quality: Reluctant Regulators. Farmham: Ashgate. Healy, J Regulating the Health Professions: Protecting Professionals or Protecting Patients? In Health workforce governance, edited by SD Short and F McDonald. Surrey: Ashgate, Hendee, W The patient safety movement. Applied Radiology. 33(8). Retrieved from: HG.org-Legal Resources. What are the surgical errors that can lead to a medical malpractice case? Retrieved from: Jena, A, Seabury, S, Lakdawalla, D, Chandra, A Malpractice risk according to physician specialty. The New England Journal of Medicine. Doi: /NEJMsa Leap, LL. Full Disclosure and Apology. Available at: me-a

38 Levinson, W and Gallagher, TH Disclosing medical errors to patients: a status report in Canadian Medical Association Journal, 177(3), McDonald, F Scandals, Public Inquiries and Health Professional Regulation, in Health workforce governance, edited by SD Short and F McDonald. Surrey: Ashgate, McDonald, F The regulation of health professionals, in Health Law in Australia, edited by B. White, et al. Sydney: Thomson, Mello, M., Kelly, C and Brennan, T Fostering rational regulation of patient safety. Journal of Health Politics, Policy and Law, 30(3), Nevid, J Psychology: Concepts and Applications. Canada: Wadsworth. OECD, Medical Malpractice: Prevention, Insurance and Coverage Options. Paris: OECD Publications. Poortinga, W and Pidgeon, N Trust in risk regulation: cause or consequence of the acceptability of GM food? Risk Analysis, 25(1), Qureshi, NA, Neyaz, Y, Khoja, T, Magzoub, MA, Haycox, A, Walley, T Physicians medication prescribing in primary care in Riyadh city, Saudi Arabia. Literature review, part 3: prescribing errors. Eastern Mediterranean Health Journal. Vol. 17. Retrieved from: Reason, J Human Error. Cambridge: Cambridge University Press. Siddiqi S et al Patient Safety Friendly Hospital Initiative: from evidence to action in seven developing country hospitals. Int J Qual Health Care 24: Sorrell, T Safety, accountability and choice after the Bristol Inquiry, in Informed Consent and Clinical Accountability: The Ethics of Report Cards on Surgeon Performance, edited S Clarke and J Oakley. Cambridge: Cambridge University Press,

39 Samarkandi, A. (2006). Medico-legal liabilities of anesthesia practice in Saudi Arabia. Middle East Journal of Anesthesiology. 18 (4). Sari, A, et al Sensitivity of routine system for reporting patient safety incidents in an NHS hospital: retrospective patient case note review. British Medical Journal 334:79. Singh, B, Ghatala, M Risk management in hospitals. International Journal of Innovation, Management and Technology. Vol. 3(4). The Royal Liverpool Children s Inquiry, Report of the Royal Liverpool Children s Inquiry. London: HMSO. The Shipman Inquiry Death Disguised. London: HMSO. The Shipman Inquiry Safeguard Patients: Lessons from the Past Proposals for the Future. London: HMSO. Walshe, K Regulation in Health Care, edited by J Heally and P Dugdale. Crows Nest NSW: Allen & Unwin, Wilson RM, Michel P, Olsen S, Gibberd RW, Vincent C, El-Assady R, et al Patient safety in developing countries: retrospective estimation of scale and nature of harm to patients in hospital. BMJ;344:e832 World Health Organization Project Proposal: Establishing a framework for patient safety in the Eastern Mediterranean Region: The Patient Safety Friendly Hospital Initiative. Available at: %20proposal%20July%2008.pdf World Health Organization World Alliance for Patient Safety: The Conceptual Framework for the International Classification for Patient Safety: Final Technical Report. Geneva: World Health Organization. 39