By Prof. Susirith Mendis

Preamble

The newspapers and social media have been full of news during the last few weeks about incidents in hospitals, which led to the death of patients. Obviously, we are aware of such incidents more now than then due to the feverish activity of social media.

The latest was the untimely and unnecessary death of Chamodi Sandeepani, a 21 year-old girl in the Teaching Hospital, Peradeniya. According to the mother of Chamodi, her daughter’s condition deteriorated and her body turned blue after the administration of two medications by a nurse. One of them had been identified as Ceftriaxone (a Cephalosporine antibiotic).

I was also truly disturbed when a very good friend of mine, a consultant anaesthesiologist – a long-time resident of UK, lost his brother, who was a card-carrying patient on his sensitivity to penicillin. He was injected with ‘Augementin’ (a combination drug of amoxicillin and clavulanic acid) in a major private hospital in Colombo and died immediately afterwards. It was alleged that the emergency tray was not readily available at the time of injection. There was hardly a ripple in the media about this incident.

Both these incidents point to anaphylactic shock. Death by anaphylactic shock occurs in all parts of the world – including the best of centres. But that does not mean that many of those were necessarily fatal. Some patients could have been revived with immediate appropriate response and emergency care. Too many incidents have been exposed in recent times about unexpected and untimely deaths of patients in hospitals. Allegations of negligence abound. These incidents must be investigated by independent investigators to ascertain the facts of each of these cases. The manner in which inquiries have been done in the past by the Ministry of Health leaves much to be desired. Most often, the end result is absolving the medical/health professionals and issues swept under the carpet. As in this case of Chamodi, where the inquiry panel is headed none other than by the DGHS – ‘a home and home affair’.

Nonetheless, as a medical professional, a medical teacher for over 40 years and a medical ethicist of some standing within and without our profession, I am most troubled by the responses and reactions I see in social media posted by doctors. There is a uniform response of criticising the victims and a myriad of excuses. There is not even a remote consideration of whether there has been negligence on the part of the medical/health professionals directly involved in the incident. There was a very recent case where a daughter who posted a bitter experience she had at the Nagoda Hospital of indifference and lack of concern and care in a facebook post. She was hounded and harassed by the police on a complaint from the hospital authorities. She was coerced by the Police to delete her post. A case of the combined effect of medical and police muscle.

A more conciliatory and introspective approach by the doctors will in the log run be more fruitful in improving the quality and standards of healthcare in the hospitals. Exuding arrogance, intimidatory self-defence and a mindset of ‘attack is the best form of defence’ is without doubt, counterproductive.My objective in this article is to look at the issues of medical negligence and medical errors in general and how they pertain to our perspective of the recent events that have taken hold of our attention during the last few weeks.

What I will not delve into in this article are the existent economic crisis that has lead to shortage of drugs, inferior drugs imported without due diligence to quality and standards, short-circuiting the due process and regulatory oversight of the National Medicines Regulatory Authority (NMRA) and the role played by the Minister of Health and the Ministry of Health. The last, but importantly, ‘clinician burnout’ due to the difficulties faced by medical and health professionals struggling to provide minimal patient care under dismal supply conditions. Collectively or singularly all of the above have directly or indirectly been responsible for these unfortunate deaths.

My comments herein, are issues related to medical negligence and medical error that are systemic as well as global.Let me start with a comment in a book that happened to catch my eye at the University of Georgetown Medical School Medical Ethics Library over 2 decades ago:

The book was “Examining your doctor: A patient’s guide to avoiding harmful medical care.” by Timothy B. McCall, MD (Carol Publishing Group, New York, 1995). This is the personal experience/confession of a doctor when he was training as a medical student in a University Hospital in te USA.

“My first experience taking care of patients as a medical student changed forever the way I viewed doctors. I was appalled. In the university hospital I was assigned, we treated one patient after another transferred from hospitals where they had received medical care that had nearly killed them. We saved some of them, though many of those we saved ended up disabled. We didn’t tell these patients or their families that they had been victims of poor medical care; we intentionally misled them. Covering up malpractice is just one example of the systematic way that doctors withhold information from their patients.”

Well, that says many things that most doctors in Sri Lanka would refuse to accept or even consider. Their arrogance ensures that they are never wrong. They can ever be wrong.

But, it is ironical that with better technology in healthcare available today, even in Sri Lanka, doctors are more likely to be found negligent. Is this because (i) medical standards have deteriorated? (ii) more doctors are now less skillful? (iii) they are now more careless? (iv) lawyers have realised that there is good money to make from ligigation against doctors? (v) patients have become more aware of their conditions (thanks to the internet) and therefore, more litigious? (vi) Insurance companies are paying good compensation? Or is it a relative permutation and combination of all of the above? I have not seen any serious scientific study done to ascertain the real situation in our country.

Let us now, look at a non-binding classification.

Medcal Negligence

It is an act of commission or omission by a healthcare provider in which care provided deviates from accepted standards of practice in the medical community and causes injury or death to the patient. To establish negligence, it is necessary to first establsih ‘duty of care’. A reasonable, foreseeable and actual loss or injury caused by or materially contributed to by a breach of duty of care will lead to an accusation of negligence.

This can be of two basic types: Criminal Negligence and Medical (or Clinical) Negligence. Criminal negligence is such that the negligence is grave enough for a police investigation and a prosecution by the Attorney General. It can lead to judicial sentencing and even imprisonment. Medical negligence, on the other hand, is a civil procedure, that could lead to damages being awarded by a Court of Law.

But prior to legal measures in a Court of Law, it is possible to pursue a lesser path of ‘pre-litigation’. This entails a departmental inquiry (Ministry of Health) which can lead from warning, transfer, punishment, reporting the the Sri Lanka Medical Council (SLMC) to even dismissal from service. A complaint to the SLMC can lead to periods of temporary suspension of registration. And in extreme instances, to complete erasure from the Medical Register.

There are even less serious avenues in instances where pateinet or their next of kin, can seek redress through a process of ‘conflict resolution’. Mediation is one of them. It has to be a voluntary process. There cannot be coercion on either parties – i.e., the doctors concerned or the patient. The parties meet privately with a neutral mediator who facilitates a negotiated agreement. This then binds the parties to that mutualyy agreed conditions of resolution of the conflict. This could be an unqualified apology to a meagre financial compensation for losses incurred. It is seen as a much more constructive and less adversarial process than conventional litigation. If agreement is not reached, the parties are free to initiate or continue with litigation.

Another non-litigious option for patients is to make a formal complaint to the Parliamentary Commissioner for Administration (better known as the Ombudsman). The present Ombudsman is a former Judge of the High Court of Sri Lanka. The former Secretary-General of Parliament, Sam Wijesinghe was the first – if my memory serves me right.

The positives of a non-litigious process is that it is (i) a non-threatening environment; (ii) it may give an increased sense of ‘fairness’ and justice for doctors; (iii) the legal and other costs are minimal and affordable to most.

The negatives are: (i) Will it give justice to the grievances of patients or their next of kin? (ii) Will the whole process be transparent and devoid of obvious bias? (iii) Will the process retain the confidence of both patients and doctors that justice has been done?

To ensure that the process is transparent and devoid of bias, there would be a need for non-medical or legal representation. Would it not be ideal, as in the Court process of ‘trial by a jury’, to have a committee of inquiry made up of competent civilians?

We, in Sri Lanka have no estimates of negligence. But, if we go by the many anecdotes of serious events of gross negligence we hear, and the number of litigation that have failed in a court f law or settled out of court, they are still a matter of very serious concern.

There are other conditions that I will not dwell at any length here. That is ‘medical misadventure’ where there is error or unexpected outcome during medical intervention leading to serious deleterious effect on patient. This happends most often in surgical and anaesthetic practice. An ‘adverse event’ is defined as an undesirable and unintentional, though not necessarily unexpected, result of medical treatment. Examples of an adverse event is discomfort in an artificial joint that continues after the expected recovery period, painful cheloids developing after open-heart surgery or a chronic headache following a spinal tap.

Medical Error

Medical error has been defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome; the failure of a planned action to be completed as intended (an error of execution); the use of a wrong plan to achieve an aim (an error of planning); or a deviation from the process of care that may or may not cause harm to the patient. Patient harm from medical error can occur at the individual or system level.

There are many ways that medical care can go wrong. Errors can occur around the administration of medications (including adverse drug events/reactions), during laboratory testing, pathology reports, hospital infections, as a result of surgery or even in documentation or data entry tasks.

Medication error are the leading cause of negligence, error and adverse events. They include; (i) prescribing errors; (ii) failure to prescribe, administer, or dispense a medication; (iii) a patient receiving a medication too late or too early; (iv) a patient receiving a drug not authorized for them; (v) improper use of a medication; (vi) wrong dose prescription or preparation; (vii) administration errors; (viii) failure to take into account a patient’s medical conditions or potential drug interactions; and (ix) not following proper dispensing/prescribing rules for a medication.

“To err is human”

An average of 195,000 people in the USA died due to potentially preventable, in-hospital medical errors in each of the years 2000, 2001 and 2002, according to a study of 37 million patient records. (The Health Grades Patient Safety in American Hospitals study (2000-02).

According to Dr. Lucien Leape, lead the author of a Harvard study, the number of deaths from medical errors in hospitals account for the equivalent to the death toll from three jumbo jet crashes every two days.( Public Health Reports , 1999; 114: 302-317 July/August, 1999).More people die each year in the United States from medical errors than from highway accidents, breast cancer or AIDS, a federal advisory panel has reported.

The report from the National Academy of Sciences’ Institute of Medicine cited studies showing between 44,000 and 98,000 people die each year because of mistakes by medical professionals. “That’s probably an underestimate for two reasons, one is, there are many different kinds of errors we never learn about — even in retrospective studies — because they are never written down. Second, these studies did not include other areas of care like home care, nursing homes and ambulatory care centers.” (Dr. Donald Berwick of the National Academic of Medicine, Washington DC). Medical error is the third leading cause of death in the US according to a BMJ article (BMJ 2016;353:i2139).

Here are some more statistics from the USA. The FDA receives more than 100,000 reports every year that are associated with medication errors (FDA, 2019). Forty-one percent of Americans report having been involved with a medical error either personally or secondhand (Institute for Healthcare Improvement/NORC at the University of Chicago, 2017). More than 7 million patients in the U.S. are impacted by medication errors every year (Journal of Community Hospital Internal Medicine Perspectives, 2016). Ten percent of hospital patients will be subject to a medication error (NCBI, 2019).By 2023, medication errors in the US has been tied to $40 billion in spending and up to 9000 deaths each year.

What about Sri Lanka?

To my knowledge, there are neither records of ‘medical error’ nor surveys or audits done for us to have an understanding, or even estimates, of medical negligence or errors in Sri Lanka. I am open to correction, if there are. The only record I know of is Professor Carlo Fonseka’s seminal article in the BMJ (Volume 313 21-28 December 1996) titled “To Err was Fatal”. In it he writes of five fatal errors he made that caused the death of five patient. I think it is compulsory reading for all doctors who have not yet read it. In it he makes five important and profound observations: (i) All doctors are fallible; (ii) The natural reaction of doctors to errors is to hide them or to rationalise them away; (iii) It is unscientific and unethical to refuse to face our errors; (iv) There is no cathartic ritual in our profession to expiate the sense of guilt generated by our errors; (v) Since knowledge grows mainly by error recognition, facing our errors squarely is the path to medical wisdom.

As Prof. Carlo Fonseka stated, doctors are not infallible, no matter how much patients would like them to be. While doctors’ mistakes are not usually intentional, they are often preventable and typically occur when doctors fail to exercise the proper level of care and skill. Hence, it is not difficult to accept that doctor errors occur more frequently than patients realise. The recent events are the tip of the proverbial iceberg.

Unfortunately, when doctors’ mistakes do happen, the consequences can be disastrous – even fatal. In which direction should we in Sri Lanka tread? The path traced by the West? Or go back to our own traditions and culture? Our social relations are based on the ‘Eastern Philosophical Tradition’. The Sri Lankan social milieu is predominantly based on Buddhist Philosophy – ‘The Four Noble Truths’ and ‘The Eightfold Path’ and the values of Meththa, Karuna, Muditha and Upeksha.

We are ‘serendipitously’ placed. We are a nation where all 4 major religions are practiced. Do we need to follow or abide by the Western medical ethical tradition coming down from Aesclepius and Hippocrates ?

We practice Modern Western Scientific Medicine in a socio-cultural milieu seeped in ancient Eastern traditions. Can we take inspiration from those traditions and synthesise a ‘New Medical ethical tradition’ by bridging this philosophical divide?

Do we have both the creativity and the courage to do so? If we have, we can in all probability avoid the pitfalls that the practice of medicine has fallen in the West (and in particular, the USA).Let these recent unfortunate and possible unavoidable deaths open us as medical professionals to a more humane and humanistic approach to patient care in Sri Lanka.