Sunday September 16, 2012
First, do no harm
By Dr MILTON LUM
There is an urgent need for the promotion of a culture of safety in healthcare, with every healthcare provider encouraged to identify and learn from errors.
MEDICINE has made tremendous progress in the past five decades. There is better understanding and knowledge about many conditions and diseases today.
It is now possible to diagnose and/or treat conditions which were once not diagnosable and/or untreatable. The diagnosis and/or treatment of many conditions and diseases have also been refined with increased effectiveness and fewer side effects for patients.
Yet, the practice of medicine is not without risks. The harms which resulted from medical treatment were called iatrogenic. The situation was aptly put by Professor Sir Cyril Chantler, who wrote in the Lancet in 1999: “Medical care used to be simple, ineffective and relatively safe; now, it is complex, effective and potentially dangerous.”
According to the World Health Organization (Source: www.who.int/ features/ factfiles/patient_safety), there is a one in a million chance of being harmed while in an aeroplane compared to one in 300 chance of harm during healthcare. Hazards of healthcare (modified from Leape)
The publication of “To err is human: building a safer health system”, “An organisation with a memory”, and “The quality in Australian healthcare study” in the 1990s reported on the hazards of healthcare. Whilst it was known for a long time that there were risks in healthcare, these studies quantified the hazards.
When the harms caused by healthcare were compared to other human activities, there was concern, even alarm, amongst governments and the medical profession.
The chances of harm from aviation and nuclear power stations, which are perceived by the public to be of high risk, are considerably less than healthcare.
According to the World Health Organization (Source: www.who.int/features/factfiles/patient_safety), there is a one in a million chance of being harmed while in an aeroplane compared to one in 300 chance of harm during healthcare.
As many as one in 10 patients in developed economies suffer harm from hospital care. A study done in some of the Health Ministry’s hospitals in 2010 reported of similar statistics.
Patient Safety Council of Malaysia
An incident which left an indelible imprint on the writer’s memory occurred when he was a first year medical officer. A 15-year-old boy who had a splenectomy for a ruptured spleen following a road traffic accident developed malaria on the third day after the operation and was prescribed chloroquine.
On the third day after the commencement of drug therapy, he developed blurred vision, ringing sound in the ears (tinnitus), vomiting, and suddenly collapsed. Resuscitation attempts were unsuccessful. A hospital inquiry concluded that the patient succumbed to chloroquine toxicity due to the dispensing of 10 times the dose prescribed. This medication error was certainly preventable.
Most doctors who have been in medical practice for some time will have direct or indirect knowledge of episodes of iatrogenic conditions and/or harms.
It is evident from various studies and reports that the provision of safe and effective care require not only competent doctors, but also well designed care processes and organisational supports. It was evident from various studies and the reports above that the provision of safe and effective care required not only competent doctors, but also well designed care processes and organisational supports. There was recognition of a need for the promotion of a culture of safety, with every healthcare provider encouraged to identify and learn from errors.
Cognizant of and alarmed by the quantified data on the hazards of healthcare, Puan Sri Dr Wong Hee Ong and the writer approached the government in 2002 to establish a Patient Safety Council with functions akin to that of similar organisations in some developed countries.
“The Patient Safety Council of Malaysia (PSCM) was formally established in January 2003 following a Malaysian Cabinet directive to ensure that the public receive safe healthcare. The formation of the Patient Safety Council of Malaysia has been formalised by the Malaysian Cabinet following the recommendations of the Honourable Minister of Health on 29th January 2003. This council is chaired by the Director General of Health Malaysia and will advise the Honourable Minister of Health on the situation of preventable adverse events as well as the measures taken to overcome them, in an effort to promote systemic improvements in the safety and quality of healthcare in Malaysia.” (patientsafety.moh.gov.my/modules/mastop_publish/?tac=Introduction)
Much has been done by the PSCM, but much more needs to be done to address issues of patient safety, which has been defined by WHO as, “the absence of preventable harm to a patient during the process of healthcare” and which involves “coordinated efforts to prevent harm, caused by the process of healthcare itself, from occurring to patients”.
Legal requirements
The Health Ministry has taken many steps to address patient safety issues in its facilities. Some private sector facilities have taken similar steps. However, there is still a gap in awareness of the fact that there are legal requirements in regard to patient safety.
The Private Health Care Facilities and Services Act (PHCFSA) require the licensee or holder of a certificate of registration to ensure only qualified and registered persons treat patients. The facility has to make available its policy statement on its obligations to patients, have a grievance mechanism, report unforeseeable or unanticipated incidents or assessable deaths, ensure safe blood transfusion, conduct mortality assessment under strict confidential rules, as well as comply with directives, orders and guidelines from the Director General of Health to ensure the quality, standards and appropriateness of the facilities and services.
In addition, the licensee has to ensure that “the medical management of patients vests in a registered medical practitioner” and that “there is established a Medical Advisory Committee whose members shall be registered medical practitioners representing all medical practitioners practising in the facility or service to advise the Board of Management, the licensee and person in charge on all aspects relating to medical practice”.
The licence of a facility can be suspended if it has “policies or issued directives that result in healthcare professionals contravening the code of professional conduct of the medical, dental or nursing or other healthcare profession issued by the Malaysian Medical Council, Malaysian Dental Council, Nursing Board or Midwifery Board or any other healthcare regulatory body”.
The PHCFSA regulations, which have been enforced since November 2006, stipulate in detail the patient safety requirements of all facilities and services. There is, however, no publication available on the degree of focus on patient safety by the regulators.
The Health Ministry has similar policies and procedures to ensure patient safety in its facilities.
Ethics requirements
All doctors and medical students know the aphorism, Primum non nocere, which is Latin for “first, do no harm”, and ad infinitum, which is Latin for “forever, without limit”.
The Malaysian Medical Council (MMC) requires all doctors to provide and maintain a good standard of medical care to patients. The Medical Act confers upon the MMC disciplinary jurisdiction over all registered doctors.
In exercising its functions, the MMC is guided by its Code of Professional Conduct (mmc.gov.my/v1/docs/Code_of_Professional_Conduct) and guidelines. The MMC can reprimand, suspend or deregister a doctor after due inquiry.
Upon receipt of a complaint, the MMC will institute disciplinary proceedings when a doctor appears to have seriously disregarded or neglected his professional duties to his patients.
Reports of incidents like medication errors, transfusion of tainted blood, inappropriate operations, ceiling collapse, and leakage of sewage materials into wards and operating theatres are a source of concern to patients and doctors. However, it should be noted that “the Council is not ordinarily concerned with errors in diagnosis or treatment, or with the kind of matters which give rise to action in the civil courts for negligence, unless the practitioner’s conduct in the case has involved such a disregard of his professional responsibility to his patients or such a neglect of his professional duties as to raise a question of infamous conduct in a professional respect”.
The MMC’s guideline, “Duties of a doctor”, provides detailed guidance to doctors on safe medical practice (mmc.gov.my/v1/docs/Good%20Medical%20Practice). Although teamwork is encouraged, it reminds that “on the other hand, a doctor may have good reason or grounds to believe that a colleague is practicing unethically or immorally, or is mentally or physically incapable of handling or treating patients. It is then his duty to bring the matter up to the attention of the Malaysian Medical Council, in the interests of the public”.
Accreditation requirements
Many hospitals are accredited by the Malaysian Society for Quality in Health (MSQH). There are 60 public and 31 private hospitals accredited as at 13 July 2012. A handful of private hospitals are also accredited by the Joint Commission International of the United States.
The International Society for Quality in Health Care, of which MSQH is an accredited member, defined accreditation in its operating rules in 1998 as “a self-assessment and external peer review process used by healthcare organisations to accurately assess their level of performance in relation to established standards and to implement ways to continuously improve the healthcare system”.
One of the six major areas of the MSQH’s Malaysian Hospital Accreditation Standards is patient safety. It is pertinent to note the MSQH’s position that safety aspects cannot be compromised. It states unequivocally that “an organisation that does not meet the safety requirements of the standards will not be accredited although it has met the rest of the standards”.
Patients for Patient Safety
However, there are reports of incidents like medication errors, transfusion of tainted blood, inappropriate operations, ceiling collapse, leakage of sewage materials into wards and operating theatres as well as private hospitals having contracts with other organisations and/or policies which contravene the MMC’s Code of Professional Conduct.
These incidents have given rise to concerns among patients and doctors. They do not help in fostering confidence that patient safety is indeed the focus of healthcare. Instead, it engenders the perception that healthcare is a commodity to be bought and sold, with corporate visions of exponential growth and turnover in the billions.
That patients need to play an active role in the healthcare provided to them is recognised globally as a crucial factor in addressing the issues of patient safety.
The socio-cultural milieu of healthcare has changed markedly in the past few decades. Patients today have access to credible information on the internet. Doctors are trained in and amenable to shared decision making and communication of risks. Paternalism in healthcare is living on borrowed time.
As many as one in 10 patients in developed economies suffer harm from hospital care. A study carried out in some of the Health Ministry’s hospitals in 2010 reported of similar statistics. The WHO “Patients for Patient Safety” is an initiative worthy of the public’s support and participation. Its London Declaration of 2006 is self-explanatory: “We, Patients for Patient Safety, envision a different world in which healthcare errors are not harming people. We are partners in the effort to prevent all avoidable harm in healthcare. Risk and uncertainty are constant companions. So we come together in dialogue, participating in care with providers. We unite our strength as advocates for care without harm in the developing as well as the developed world.
“We are committed to spread the word from person to person, town to town, country to country. There is a right to safe healthcare and we will not let the current culture of error and denial continue. We call for honesty, openness and transparency. We will make the reduction of healthcare errors a basic human right that preserves life around the world.
“We, Patients for Patient Safety, will be the voice for all people, but especially those who are now unheard. Together as partners, we will collaborate in:
● Devising and promoting programmes for patient safety and patient empowerment.
● Developing and driving a constructive dialogue with all partners concerned with patient safety.
● Establishing systems for reporting and dealing with healthcare harm on a worldwide basis.
● Defining best practices in dealing with healthcare harm of all kinds and promoting those practices throughout the world.
“In honour of those who have died, those left disabled, our loved ones today and the world’s children yet to be born, we will strive for excellence, so that all involved in healthcare are as safe as possible as soon as possible. This is our pledge of partnership.”
Can there be a similar voice in Malaysia?
Healthcare carries with it risks, some of which may result in harm to patients. There are legal and ethics requirements in respect of patient safety, which owners and managers of healthcare facilities and doctors respectively have to comply with. The activities of the Patient Safety Council of Malaysia and the accreditation bodies complement the regulators.
Current and potential patients, which means everyone, have a crucial role to play in patient safety as illness does not discriminate and can affect anyone.
Together, with the efforts of regulators and other agencies, we can all minimise the risks, and hence, the harm of health thecare.
■ Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organisation the writer is associated with.
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